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Surgalign Gains FDA 510(k) for HOLO Portal Surgical Guidance

The HOLO Portal represents the world's first artificial intelligence-driven augmented reality guidance system for spine surgery.

VUZE Medical Gains FDA 510(k) for Spinal Surgery Software

Real-time image processing enables software-only guidance and verification in minimally invasive spine surgery.

Nextremity Solutions Gains FDA 510(k) for Subtalar Joint Fusion

The InCore Subtalar system offers a three-part intraosseous fixation option for subtalar joint arthrodesis

Inspan Gains FDA 510(k) Clearance for Interspinous Plate

Inspan received FDA clearance for the Inspan interspinous plate fixation to be used for spinal fusion and spinal stenosis.

VySpine Gains FDA Clearance of VySpan PCT System

VySpan PCT features various screw and hook options, multiple transition rods and crosslink versatility.

NuVasive Gains Clearance for Expanded Use of Attrax Putty

The expanded FDA clearance applies to indications for use with NuVasive's thoracolumbar spinal interbody portfolio.

Paragon 28 R3ACT Stabilization System Cleared by FDA

R3ACT Stabilization bolsters Paragon 28's fracture and syndesmotic product offering, focused on the foot and ankle.

Spinal Simplicity Granted New Indication for Minuteman Spinal Implants

The device is FDA cleared for lumbar spinal stenosis, degenerative disc disease, spondylolisthesis, trauma and tumor treatment.

Nextremity Solutions Gains FDA Clearance for Ankle Fusion Plating

The Stratum Ankle Fusion System is a comprehensive system of anatomical plates to support anterior, lateral and posterior fusion options.

Bioventus Gains FDA Clearance for BoneScalpel Access

The BoneScalpel Access handpiece allows for en-bloc resection and the shaving and sculpting of bone.

Paragon 28’s Patient Specific Titanium Talus Spacer Approved by FDA

The supplemental approval order allows the Patient Specific Talus Spacer to be additively manufactured in titanium alloy with a titanium nitride coating.

3D-Side Gains FDA 510(k) for 3D-Cut Patient-Matched Instrument

3D-Cut is a patient-matched additively manufactured instrument to guide the marking of bone and surgical instruments in bone tumor resection.

CoreLink Launches CentraFix Midline Fixation System

The system features modular cobalt chrome tulip heads for intraoperative flexibility and increased visualization in smaller incisions.

FDA 510(k) Clearance for Active Life Scientific Bone Score Measurement Device

Active Life Sciences' assessment allows physicians to physically test bone tissue at a microscopic level.

Eminent Spine Gains FDA 510(k) for Cervical Standalone System

The system is accompanied by cervical IBFD cages in PEEK, Machined Titanium and 3D Printed Titanium and also an Anterior Cervical Plate.

PrecisionOS Gains FDA 510(k) for InVisionOS Planning Tool with Virtual Reality

The patented software, to be available in early 2022, lets surgeons use an Oculus Quest 2 device to do preoperative planning.

FDA 510(k) for nView s1 Surgical Navigation

nView s1 integrates low-dose x-ray imaging and AI-enabled imaging algorithms to provide multiplanar, fluoroscopic and augmented views.

Trice Medical Granted FDA 510(k) for mi-eye 3 needlescope

The device provides maneuverability and expanded views into small joints that are inaccessible to other available arthroscopes.

Naviswiss Gains FDA Clearance for Hip Replacement Planning

Naviplan is a digital pre-operative planning application enabling surgeons to perform navigated CT-based total hip replacement.

Life Spine Gains FDA 510(k) Clearance for ProLift Micro Expandable Spacer

ProLift micro is designed to support micro invasive procedures ranging from endoscopic TLIFs to MIS TLIFs/PLIFs.

ChoiceSpine Granted FDA Clearance of Triton SI Joint System

The 3D-printed screw is intended for conditions including degenerative sacroiliitis and sacroiliac joint disruption.

NGMedical Gains FDA 510(k) for AM Titanium Lumbar Interbody BEE PLIF

The BEE PLIF interbody cage has been created to benefit from additive manufacturing features.

Kleiner Device Gains FDA 510(k) for KG2 Interbody System

The KG 2 Surge flow-thru interbody maximizes bone graft delivery volume and distributes graft bilaterally into the intervertebral disc space.

Anika’s Tactoset Injectable Bone Substitute Now FDA-Cleared for Hardware Augmentation

The injectable bone substitute is now FDA 510(k) cleared for augmenting suture anchor fixation.

Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

The clearance follows existing clearances by the FDA for the use of MagnetOs Granules and MagnetOs Putty in the spine.

Royal Biologics Gains FDA 510(k) for Maxx Concentration System

Maxx-PRP is a next-gen device to concentrate autologous whole blood for the safe and rapid preparation of platelet-rich plasma.

Intelivation Technologies Gains FDA 510(k) for Advantage-C

Advantage-C was developed to optimize fusion, while maintaining elasticity that is similar to bone and radiolucency of the cage body.

joimax Gains FDA Clearance to Market EndoLIF Delta-Cage and DoubleWedge-Cage

The devices are used for intervertebral body fusion in the lumbar spine for diseases such as degenerative disc disease.

Radiobotics Gains FDA 510(k) for Knee Osteoarthritis Analysis Tool

RBknee is an AI-based analysis tool aimed at improving the efficiency and accuracy of radiographic knee osteoarthritis diagnosis.

In2Bones Receives FDA Clearance for Pre-Surgery OrthoPlanify

The clearance includes the pre-surgery patient-specific planning software and 3D-printed cutting guides for the QUANTUM Total Ankle.

Tyber Medical Granted FDA 510(k) Clearance for Anatomical Plating

This represents the company's largest FDA 510(k) and marks expansion into fixation devices for all long and short bones.

Intelivation Technologies Gains FDA 510(k) for Golden Isles Pedicle Screw

Golden Isles features both standard and reduction tulips, along with a comprehensive set of insertion and reduction instruments.

MiRus Gains FDA 510(k) for IO Expandable Lumbar Interbody

The IO Expandable Lumbar Interbody, powered by the MoRe Expansion Engine, offers the lowest profile interbody on the market.

FDA De Novo Classification Grant for Zimmer Biomet Persona IQ Knee

The Persona IQ Knee combines Zimmer Biomet's Persona Knee with Canary Medical's canturio™ te Tibial Extension sensor technology.

Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

The InSet Platform is designed to simplify shoulder replacement technology to improve outcomes for patients.

Zimmer Biomet Gains FDA Clearance for ROSA Hip System

ROSA Hip and ONE Planner Hip complement current robotic solutions for total and partial knee replacement.

Globus Medical Announces FDA 510(k) Clearance for Excelsius3D

The 3-in-1 platform consolidates 360 cone-beam CT, fluoroscopy and high-res digital radiography, eliminating the need for multiple imaging systems in one procedure.

Auctus Surgical: FDA Breakthrough Device Designation

The designation is a recognition that the Auctus dynamic vertebral body tethering system is unique and will meet a clear clinical need.

Camber Spine Gains FDA 510(k) for SPIRA-P and SPIRA-T Technologies

These lumbar interbody fusion devices are indicated to treat Degenerative Disc Disease at one or two contiguous levels from L2-S1.

The Orthopaedic Implant Company Launches DRPx Wrist Fracture Plate

DRPx is the only distal radius plating system with an ergonomic design to meet the technique preferences of surgeons while increasing cost savings.

Aurora Spine Gains FDA 510(k) Clearance for DEXA-C Cervical Interbody

The clearance is the first in the world using Aurora's proprietary DEXA Technology for custom made implants based upon matching patient's bone density.

NuVasive Gains Latest FDA 510(k) for Pulse Platform

NuVasive announced the commercial launch of Pulse, which is now available for sale in targeted global regions.

ARVIS Augmented Reality Gains FDA 510(k) Clearance

ARVIS is the first wearable surgical navigation system to be cleared for both hip and knee arthroplasty.

SeaSpine Gains FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery

This clearance represents a new application and increased functionality for its 7D Flash Navigation System.

Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

HYALEX Cartilage is intended to repair defects and restore function for patients with loss of knee articular cartilage and bone requiring surgery.

Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

This is the first closed-loop suture fixation for soft tissue to soft tissue repair of certain types of injuries, designed for less-invasive procedures.

Interventional Systems Gains FDA 510(k) for Micromate Head-to-Toe Medical Robot

Micromate, available in the U.S. spine fusion landscape through partner company Fusion Robotics, can perform almost every non-invasive image-guided procedure.

CoreLink Gains FDA Clearance for F3D Corpectomy System

CoreLink expands 3D printed spine implant portfolio with a wide range of implant size options, intuitive instrumentation and Mimetic Metal technology.

Onkos Surgical Gains FDA 510(k) Clearance for BioGrip Modular Porous Collars

The new offering, part of the ELEOS Limb Salvage System, is designed to support bone ingrowth in musculoskeletal oncology and complex orthopaedic limb salvage cases.

Breakthrough Designation for MIScoli Vertebral Body Tethering

MIScoli is a vertebral body tethering device designed to treat scoliosis in young adolescents.

Regulatory Clearances for NEO Pedicle Screw with BonOs Inject Cement

Neo received 510(k) clearance and approval under the CE Mark for the system plus BonOs Inject cement from OSARTIS in an advanced stage tumor indication.

Breakthrough Designation for BONESUPPORT CERAMENT G for Trauma

CERAMENT G is classified as a breakthrough device for the indication osteomyelitis since March 2020.

OXOS Medical Gains FDA Clearance for Micro C in Pediatrics

FDA recommends that pediatric medical x-ray imaging exams use the lowest radiation dose necessary, and that efforts should be made to minimize risk.

Vuzix Smart Glasses to Support Shoulder, Knee and Spine Surgeries

Vuzix announced the market expansion to support the NextAR surgical augmented reality platform developed by Medacta.

Medtronic Gains FDA Clearance for UNiD Patient-Specific Rods with CD Horizon Solera Voyager and Infinity OCT

The compatibility of Medicrea UNiD Rods with Medtronic's spinal systems supports integration of AI-driven surgical planning, robotic assisted surgery, etc.

Medacta Gains Regulatory Clearances for NextAR Surgical Planning Applications

Medacta's knee, shoulder and spine applications received CE Mark approval, and its shoulder application obtained FDA 510(k) clearance.

FDA Clearance for ChoiceSpine Blackhawk Ti Cervical Spacer

Blackhawk Ti improves and builds upon the already successful original Blackhawk PEEK device with integrated anchor technology.

Breakthrough Designation for PerQdisc Nucleus Replacement for Degenerative Disc Disease

PerQdisc replaces the nucleus pulposus of the intervertebral disc in the L1 - S1 spinal region in patients with single-level discogenic pain.

CUREXO Gains FDA 510(k) Clearance for CUVIS-spine Surgical Robot

Using a high-precision robot arm, CUVIS guides the insertion of a pedicle screw according to the surgery plan.

Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

The implant is the first biocomposite soft tissue scaffold designed to reinforce tendon and ligament repairs and fully resorb.

Orthofix Gains FDA Clearance of OrthoNext Digital Platform for the JuniOrtho Plating System

The OrthoNext platform enables deformity analysis and preoperative planning for pediatric orthopedic procedures with the JuniOrtho Plating System.

FDA Clearance for Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot

THINK Surgical and Ortho Development gained FDA clearance for use of the Balanced Knee System and BKS TriMax Implants with the TSolution One Total Knee Application Active Robot.

Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

Identity Imprint is designed to match patients' anatomy while offering efficiency, cost savings, intraoperative flexibility and faster delivery.

Genesis Software Innovations Gains FDA 510(k) Clearance For Preview 3D Shoulder Arthroplasty Planning Software

PreView software allows surgeons to perform surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model.

Paragon 28 Gains FDA 510(k) Clearance for MAVEN Patient-Specific Instrumentation Surgery

MAVEN PSI is a platform technology designed to expedite accurate positioning of the APEX 3D Total Ankle Replacement.

Life Spine Gains FDA 510(k) Clearance for PROLIFT Lateral HELO Fixation

PROLIFT Lateral HELO is an expandable lateral spacer with integrated plating to restore disc height plus additional lateral stabilization.

Next Science Gains FDA 510(k) for Antimicrobial Solution

XPERIENCE residual solution remains in the surgical site after closure and continues to help defend against pathogens for several hours.

Pixee Medical Receives FDA Clearance for Knee+

Knee+ is designed to provide real-time positioning of instruments, right in the surgeon's field of view.

Osteotec Gains FDA 510(k) Clearance for ChiroKlip

ChiroKlip is a self-fixing disposable device that protects the protruding ends of K-wires.

Conformis Hits Regulatory Milestone in Agreement with Stryker

With FDA clearance for patient-specific instrumentation, Conformis achieved its 3rd milestone and will receive $11 million from Stryker.

Orthofix Gains FDA Clearance for 3D-Printed FORZA Titanium TLIF Spacer

The system expands the line of PEEK, PTC and now titanium interbody offerings from Orthofix for transforaminal lumbar applications.

Zimmer Biomet Gains FDA Clearance for ROSA Partial Knee

The clearance addresses the ROSA Partial Knee System for robotically-assisted partial knee replacement surgeries.

Spinal Elements Gains FDA Clearance of Lucent 3D-Printed Interbodies

Lucent 3D spinal devices are designed to maximize bone graft volume and contain delivery of graft material.

Avitus Orthopaedics Gains FDA Clearance for Expanded Indications of Avitus Bone Harvester

The Avitus Bone Harvester is now indicated for debridement and capture of diseased cancellous bone such as osteomyelitis and tumors.

Empirical Spine Receives Breakthrough Device Designation for LimiFlex

Key potential benefits cited in the application include less invasive/shorter surgery, improved outcomes, reduction of hospitalization length of stay, etc.

Orthofix Gains FDA Clearance for 3D-Printed CONSTRUX Mini Ti Spacer

Designed with nanoscale surface features, CONSTRUX Mini Ti is Orthofix's first 3D-printed titanium interbody introduced to the market.

Premia Spine’s TOPS Granted Breakthrough Device Designation

The TOPS Spinal Arthroplasty system is designed to offer a new treatment option for patients with spinal stenosis and spondylolisthesis.

NGMedical Receives FDA Clearance for BEE HA Cervical Cage

The BEE HA cervical interbody is made of PEEK-OPTIMA HA Enhanced from Invibio Biomaterial Solutions.

GE Healthcare Gains FDA Clearance of New 3D Surgical Imaging

OEC 3D combines the benefits and familiarity of 2D imaging with greater efficiency to increase access and usability to 3D.

Aurora Spine Gains FDA 510(k) Clearance for APOLLO Anterior Cervical Plate

APOLLO is part of the DEXA portfolio, positioned to reshape the market through patent focused innovation and address the next advancement in spine surgery.

Life Spine Announces FDA 510(k) Clearance for the PROLIFT Wedge Expandable Spacer System

PROLIFT Wedge Expandable marks the company's 11th expandable 510(k) clearance, including expandable solutions for PLIF, TLIF and LATERAL procedures.

4WEB Medical Receives 510(k) Clearance for Lumbar Plating Solution

The company has procedural-based solutions for Direct Lateral, Anterior-to-Psoas and Prone Lateral approaches to the lumbar spine.

Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder System

Catalyst can now address stemless anatomic and reverse TSA, the two fastest growing segments of the shoulder replacement market.

Cuptimize Gains 510(k) for Cup Placement Software

The proprietary software is designed to identify and treat spinopelvic motion abnormalities in total hip replacement.

Acuitive Technologies Gains FDA Clearance for CITRESPLINE and CITRELOCK Ligament Reconstruction

CITRESPLINE/CITRELOCK is intended to engage tendons and ligaments within a bone tunnel while preserving soft tissue integrity during insertion.

Fusion Robotics Gains FDA Clearance for Spinal Navigation & Robotics

Fusion Robotics addresses limitations of current navigation and robotics with greater procedural efficiency at significantly less expense.

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

The biomimetic graft for osteochondral lesions is the company's second Breakthrough Device designation granted in 2021.

FDA Clearance for G21 SpaceFlex Shoulder

The SpaceFlex Shoulder is now available in the U.S., joining G21's hip and knee modular spacer mold systems.

Altior Trauma Gains FDA Clearance for Artemis Proximal Femoral Nail

Artemis offers a hip fracture treatment that combines the strength of titanium with a blend of Solvay Zeniva carbon fiber reinforced PEEK.

Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Receive FDA Clearance

Loop-X is the first fully robotic mobile intra-op imaging device on the market, and Cirq Robotic Alignment will be used with Brainlab navigation software.

Episurf Medical Plans to Submit Patellofemoral System for 510(k)

The application for the two-component patellofemoral implant is slated for filing in 2021, followed by launch in 2022.

FX Solutions Gains FDA Clearance for Easytech Stemless Anatomic Shoulder

Easytech is the only primary peripheral fitting anatomic stemless shoulder on the market.

FDA Approves Additive Orthopaedics’ Patient Specific Talus Spacer

Additive Orthopaedics received an approval order for its Humanitarian Device Exemption application for treatment of avascular necrosis.

Medacta Gains Clearance for Total Hip Planning Tools

MyHip Planner and MyHip Verifier are personalized solutions used in primary total hip replacement.

Acuitive Technologies Gains FDA 510(k) Clearance for CITREFIX Knotless Suture Anchor

The CITREFIX Knotless Suture Anchor features CITREGEN material technology, a new generation bioresorbable synthetic polymer.

LimaCorporate Gains Regulatory Approvals for Smart SPACE Digital Platform

The Smart SPACE digital platform features novel orthopedic technology and a pipeline of landscape-changing applications for the shoulder.

Precision Spine Receives FDA 510(K) Clearance for Dakota ACDF Standalone System

The system features a titanium plate PEEK cage with cortical cancellous screws and a large cavity for autogenous bone graft.

NGMedical Granted FDA Clearance for AM Titanium Cervical Interbody BEE

This is NGMedical's first FDA clearance for its spinal devices.

BioPoly Gains FDA Clearance of Great Toe Implant

With this FDA clearance, BioPoly technology is available for the first time in the U.S.

icotec Begins U.S. Launch of BlackArmor Anterior Cervical Plate

icotec's Anterior Cervical Plate is the only 100% nonmetallic and radiolucent ACP with a plate and screws made of Carbon/PEEK available in the U.S.

Inspired Spine Gains FDA Clearance for Trident SI Joint Screw

The system can significantly improve procedure efficiency, resulting in surgery durations less than 15 minutes.

Spinal Elements Gains FDA Clearance of Lucent XP-Curved Expandable TLIF

The device allows for steerable placement of the implant followed by the expansion of the implant's height, once surgically placed.

ChoiceSpine Gains Additional Clearance for Cervical Spacer

The latest 510(k) for the Tiger Shark Cervical Spacer addresses sizes that enhance the ability to treat a wider variety of patient anatomies.

OrthoSpin Gains FDA Clearance for G2 System

This is the company's second generation robotic digitally-enabled external fixation system for orthopedic treatments.

DePuy Synthes Gains FDA Clearance for VELYS Robot with ATTUNE Knee

The VELYS Robotic-Assisted Solution adapts to the surgical workflow, and helps surgeons execute accurate bony cuts.

CognitOss Granted FDA Breakthrough Device Designation

Locate Bio developed CognitOss resorbable antibiotic-loaded bone graft to treat osteomyelitis.

OrthoPediatrics Launches Sterile Implants for PNP|FEMUR

Worldwide, the PNP | FEMUR system has been used to treat over 1,000 children since its launch in 2018.

Carbon22 Granted FDA 510(k) Clearance for Creed Cannulated Screw

Carbon22's ortholucent manufacturing technology offers several key benefits, including radiotransparency.

Miach Orthopaedics Granted FDA De Novo Approval for Treatment of ACL Tears

The Bridge-Enhanced ACL Repair (BEAR®) Implant is the first medical technology to clinically demonstrate or restoration of a torn ACL.

Medtronic Gains Clearance for Robotic Guidance Tools

FDA cleared Midas Rex Drills and Navigated Disc Prep and Interbodies for use with the Mazor Robotic Guidance.

SeaSpine Gains FDA Clearance for Amended Indication for NanoMetalene Surface Technology

SeaSpine is permitted to describe the surface technology as offering a "microscopic roughened surface with nano-scale features” and amends indications across 12 implant systems.

Carlsmed aprevo Interbody Gains FDA Clearance, Breakthrough Device Designation

FDA has determined that aprevo provides for more effective treatment of an irreversibly debilitating condition than the current standard of care.

Zebra Medical Gains FDA 510(k) for AI Technology

The company's AI solution extracts 3D bone reconstruction from x-ray scans at the same quality as CT, enabling use of standard X-rays for surgery planning.

Ensemble Orthopedics Gains FDA Clearance For PyroCarbon CMC Interpositional Implant

The Ensemble CMC was designed to treat early-stage osteoarthritis of the carpometacarpal joint using a minimally invasive procedure.

THINK Surgical Gains FDA Clearance of Second-Generation Active Robot

The clearance brings enhancements to the TSolution One Total Knee Application currently in use in hospitals and ASCs in the U.S.

Armis Biopharma Gains FDA Clearance for VeriFixx Small Bone Implant

VeriFixx is cleared for fixation of osteotomies and reconstruction of lesser toes following correction procedures for claw, mallet and hammertoe.

CurveBeam Gains FDA 510(k) Clearance for HiRise Weightbearing CT for Lower Extremities

The HiRise weight bearing CT imaging system addresses all orthopedic lower extremity applications, and can scan anywhere from the hip & pelvis to the feet.

icotec Gains FDA Clearance for VADER Pedicle System

VADER is designed to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors.

NuVasive Gains FDA Clearance for Thoracolumbar Interbodies

NuVasive's thoracolumbar interbodies are the only implants to be clinically validated in and indicated for the treatment of sagittal deformities.

IlluminOss Medical Receives FDA Clearance for Use in Femur, Tibia Fractures to Support Hardware

The clearance allows Photodynamic Bone Stabilization to be used in femur and tibia fractures as supplemental fixation to FDA-cleared fracture systems.

Nvision Biomedical Gains 1st 510(k) for a PEEK-OPTIMA HA Enhanced Osteotomy Wedge

After initially focusing on spinal implants, Nvision is now applying many of the same technologies to lower extremity surgery.

Anika Announces FDA 510(k) Clearance for its WristMotion Total Arthroplasty System

WristMotion is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis or post-traumatic arthritis.

Embody Gains FDA 510(k) Clearance of TAPESTRY Biointegrative Implant for Tendon and Ligament Repair

TAPESTRY is a bioengineered collagen-based implant with a proprietary micro-architecture specifically designed for tendon and ligament repair.

Acuitive Technologies Gains FDA Clearance for CITREGEN CITRELOCK Tendon Interference Screw

The CITREGEN CITRELOCK Tendon Interference Screw is made from the first FDA-cleared thermoset bioresorbable synthetic polymer.

Tyber Medical Receives FDA Clearance on Foot and Ankle Plating Systems

The clearance covers 42+ indication-specific anatomical plating families, developed via CT scans, cadaveric labs and surgical consultation.

OSSIO Granted FDA 510(k) for OSSIOfiber Compression Screw

The company also successfully surpassed the 1,000th implantation of its bio-integrative OSSIOfiber implants in the extremities.

Implanet and SeaSpine Gain FDA Clearance of the Mariner Cap System

Mariner Cap was developed to facilitate the treatment of adult degenerative disorders by offering novel stabilization of pedicle screws.

WishBone Medical Granted FDA Clearance for Smart Correction External Fixator

The Smart Correction external fixator and proprietary software offer greater efficiency and accuracy for surgeons treating children.

FH Ortho Gains FDA Clearance for Telegraph Evolution Humeral Nail

Telegraph Evolution is a next generation system for use in proximal and/or mid-shaft humeral fractures.

Captiva Spine Granted U.S. Patent for Posterior SI Joint Fusion

The patent addresses Quadracentric carpentry which prepares the sacroiliac joint for an easy, repeatable SI joint fusion.

Orthofix Granted Additional FDA Clearance for FIREBIRD SI Fusion

FIREBIRD SI Fusion System is the first 3D-printed titanium bone screw with nanotechnology to compress and stabilize the SI joint during fusion.

SurGenTec Gains FDA Clearance for 3D GraftRasp System, Including Key Spine Indications

3D GraftRasp is the only device to receive FDA clearance for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft.

Conformis Granted 510(k) Clearance for Cordera Hip

Cordera Hip with optional patient-specific instrumentation and personalized surgical plans joins the 3D Conformis Hip System,

Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System

The circular external fixator can treat complex foot and ankle deformities as well as provide a static frame for various indications.

AMDT Gains 510(k) clearance for SixFix Circular Fixation System Accessories

SixFix addresses extremity applications in trauma, foot and ankle, and deformity correction for both adults and pediatrics.

RTI Surgical Gains FDA Clearance for Dynamic Active Compression Plate

The zero-step locking plate provides continuous compression and torsional stability.

Life Spine Gains FDA 510(k) for SI Joint Revision, New Claims for SImpact Sacroiliac Joint Fixation System

The new clearance adds a 14.5mm screw to Life Spine's SI fixation portfolio, and also new SImpact claims, indications and lengths have been cleared.

Spineology Gains De Novo Grant for OptiMesh Expandable Interbody Fusion

Spineology is preparing for a 1Q21 launch of the OptiLIF lumbar spinal procedure using the OptiMesh device.

ExsoMed Gains FDA Clearance of 4 Corner Fusion System for Wrist Arthritis

ExsoMed will sell the asset to remain focused on its sterile-packed, single-use business of fracture repair devices.

Medacta Receives FDA Clearance for the Lateralized Glenosphere

The clearance expands Medacta's shoulder replacement offerings, broadening the range of options for reverse shoulder arthroplasty.

MicroPort Orthopedics Focuses on Portfolio Expansion During COVID Slowdown

The company's exposure in global markets caused revenue declines of -24% in 1H20, but MicroPort launched several new products to spur future growth

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CTL Amedica Gains FDA Clearance for MONDRIAN LIF Cage

MONDRIAN LIF features a large graft window, radiographic markers, a self-distracting bullet tip and a bi-convex profile and lateral aperture.

ExsoMed Gains FDA Clearance of InFrame Intramedullary Micro Nail for Proximal Phalanx Fractures

The threaded micro nail provides surgeons with a minimally invasive solution to optimize outcomes of proximal phalanx fracture surgeries.

SurGenTec Gains FDA Clearance for OsteoFlo NanoPutty

OsteoFlo NanoPutty bone graft features the world's first quadphasic synthetic bone graft particles with nano-surface technology.

IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures

The indication expansion follows recent clearance for use in fractures of the pelvis, the clavicle and small bones of the hand and foot.

Innovasis Gains FDA 510(k) for Interbody Fusion Devices with HAnano Surface Technology

The company is growing its hydroxyapatite spine portfolio with first to market HAnano Surface modified 3D-printed IBF titanium implants.

Life Spine Gains FDA 510(k) for the PLATEAU-X Ti Lateral Lumbar Spacer

The PLATEAU-X Ti Lateral Lumbar Spacer enables surgeons to effectively provide anterior column support through a lateral approach.

Safe Orthopaedics Gains FDA 510(k) for Next-Gen SteriSpine PS

The acceleration of outpatient spine surgeries in ASCs represents a new business opportunity for Safe Orthopaedics in the U.S.

FDA Clears joimax Intracs em Electromagnetic Navigation System for Endoscopic Minimally Invasive Spine Surgery

The Intracs em Navigation System allows for spinal procedures to be carried out with minimal X-ray control, reducing radiation exposure and access time.

Life Spine Announces FDA 510(k) Clearance for the PLATEAU-A Ti Anterior Lumbar Spacer System

The device joins the DYNA-LINK Titanium Stand-Alone ALIF Spacer and SENTRY ALIF Plating System, expanding the ALIF portfolio.

Nextremity Solutions Gains FDA 510(k) Clearance for Reduced Size Foot Plating System

This expansion of the Stratum brand will result in close to 70 options to treat deformities and fractures in the human foot.

Orthofix Gains Regulatory Clearances for JuniOrtho Plate

The JuniOrtho system is now FDA 510(k) cleared and has CE Mark approval supporting advanced deformity and trauma reconstruction of the lower extremities in pediatric patients.

Anika Launching Sports Medicine and Extremities Products in 3Q20

The FDA-cleared systems mark the first products launched from acquisitions of Parcus Medical and Arthrosurface, completed in early 2020.

Subchondral Solutions Gains FDA Clearance for S-Core Platform

S-Core Core-preserving Osteochondral Reconstruction and Joint Repair Platform Technology addresses the fundamental issue of joint damage.

Paragon 28 Gains FDA Clearance for APEX 3D Total Ankle

APEX 3D features porous 3D-printed implants and Vitamin E infused highly cross-linked polyethylene.

Medacta Gains FDA Clearance for Augmented Reality Knee Platform

NextAR Augmented Reality for total knee arthroplasty is the first application of a new technology that will extend to hip, shoulder and spine.

Nextremity Solutions Gains FDA Clearance for Cannulated Hammertoe System

The DuoHex CH System addresses hammertoe deformity and provides surgeons with a novel two-piece threaded implant construct.

Spinal Elements Gains FDA Clearance of Sapphire X Anterior Cervical Fixation

While MIS procedures typically focus on incision size, MIS Ultra considers post-op implications such as disruption of skeletal and muscle tissue.

Engage Surgical Gains FDA Clearance for Cementless Partial Knee

This is reported to be the only cementless partial knee system available in the U.S. It is cleared for both cementless or cemented fixation.

CoreLink Gains FDA Clearance of Stand-Alone Cervical System

F3D-C2 features the only 3D-printed technology with both a trabecular structure and directional support lattices.

IlluminOss Gains FDA Clearance for Treatment of Pelvic, Clavicle and Small-Bone Fractures

The new indication expansion significantly broadens the Photodynamic Bone Stabilization System to address the geriatric fragility fracture market.

Orthofix Gains FDA Clearance for FIREBIRD SI Fusion

The 3D-printed bone screw is designed to relieve pain from sacroiliac joint dysfunction.

Conformis Gains FDA Clearance for iTotal Identity PS

iTotal Identity PS joins iTotal Identity CR as the latest personalized knee joint replacement technology from Conformis.

SIRAKOSS Receives FDA Clearance for Osteo3 ZP Putty

Osteo3 ZP Putty combines best-in-class bone repair with intraoperative ease-of-use for spine and trauma bone grafting applications.

Naviswiss Gains FDA Clearance for Miniature Hip Navigation

The clearance addresses primary and revision hip procedures. The system can be used with a variety of surgical approaches and most implants on the market.

4WEB Medical Gains FDA Clearance for Stand-Alone Anterior Lumbar Interbody Fusion

The company is expanding its Anterior Spine Truss System with the addition of integrated fixation.

Nexxt Spine Gains FDA Clearance for ALIF and Lateral Systems

ALIF launches August 2020 and Lateral in September 2020. An integrated plate system is slated for for each product in 4Q.

Axis Spine Gains FDA Clearance for Axis-ALIF

Axis has developed a platform technology of build in situ modular cages as an alternative to conventional designs.

Nextremity Solutions Gains FDA Clearance for Metatarsophalangeal Joint Arthrodesis System

The continued expansion of Nextremity Solutions' portfolio addresses additional complications in the foot.

Zebra Medical Vision Gains FDA Clearance for Spine Fracture AI Solution

Zebra-Med secured clearance for a product helping to identify more patients at risk of osteoporosis, as 70% of VCFs are underdetected globally.

Back 2 Basics Gains FDA Clearance for eCarbon Spinal Rod

This is the first carbon composite spinal rod cleared for market as an adjunct in the treatment of spinal indications, other than oncological.

HD LifeSciences Gains FDA Clearance for Hive ALIF Standalone

Hive lattice devices with NanoHive Surface Technology is designed to offer ideal elastic modulus, diagnostic imaging and osteogenic properties.

Medacta Expands its Hip and Shoulder Portfolio

Medacta gained FDA clearance for its M-Vizion Femoral Revision System and its Long Humeral Diaphysis for shoulder joint replacement.

Corin’s OPSInsight Gains FDA Clearance for Total Hip Replacement

The new cloud-based software brings Corin's Optimized Positioning System onto a dynamic online platform for use in total hip arthroplasty.

Camber Spine Launches New Anterior Cervical Plates

The SPIRA-C Standalone Integrated Interbody and the FORTICO Anterior Cervical Plate are FDA 510(k)-cleared and ready for U.S. launch.

NuVasive Expands Advanced Materials Science Implant Portfolio

The AMS implant portfolio includes proprietary surface and structural technologies to enhance biomechanical properties of materials for spine procedures.

Life Spine Gains FDA Clearance for Additions to ARx

The clearance addresses implant and instrument additions to the system. ARx is Life Spine's fourth 510(k) clearance in 2020 with 92 total since inception.

Nanovis Awarded FDA Clearance for Nano FortiFix Pedicle Screw

This is the first pedicle screw system with a Nanotechnology designation and osteoblast/stem cell data comparing performance to other surface types.

Atlas Spine Gains FDA Clearance for Expandable Stand-Alone Cervical Interbody

HiJAK SA joins first-to-market HiJAK AC and the V3 segmental plating system as the latest technology in Atlas Spine's disruptive design portfolio.

Hyprevention Receives FDA Clearance for V-STRUT Vertebral Implant

With the V-STRUT system, two PEEK polymer implants are inserted in the vertebral body through the pedicles and combined with PMMA bone cement to treat VCFs.

TDi SonoVision Gains FDA Clearance for Ultrasound Spinal Imaging

SonoVision visually differentiates spinal nerve, muscle, bone and vessels in real time.

Bodycad Gains FDA Clearance for BC Fine Osteotomy

BC Fine Osteotomy is the first personalized planning and plating system for osteotomies around the knee.

OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet’s Persona Knee

OrthoSensor was granted FDA 510(k) clearance for Alignment capabilities with VERASENSE™ Sensor-Assisted Technology for use with Zimmer Biomet's Persona Knee.

Nexxt Spine Launches Nexxt Matrixx Corpectomy

Nexxt Spine received FDA 510(k) clearance of the Nexxt Matrixx® Corpectomy System, and commenced product launch.

Gramercy Extremity Orthopedics Gains FDA Clearance for GEO FirstFuse MTPJ Fusion Plate

Gramercy Extremity Orthopedics was granted FDA 510(k) clearance for the GEO FirstFuse MTPJ Fusion Plate.

OrthoPediatrics Gains Expanded Indications for RESPONSE Scoliosis System

OrthoPediatrics was granted FDA 510(k) clearance to expand indications for the RESPONSE™ Scoliosis System to include neuromuscular implants.

Extremity Medical Gains FDA Clearance for KinematX Total Wrist

Extremity Medical received FDA 510(k) clearance for the KinematX Total Wrist. Launch will occur by the end of 2020.

CoNextions Gains FDA Clearance of Coronet Tenodesis Product

CoNextions was granted FDA 510(k) clearance for the Coronet™ tenodesis system for fixation of tissue to bone and tissue to tissue.

OSSIO Gains FDA Clearance for OSSIOfiber Hammertoe Fixation

OSSIO was granted FDA 510(k) clearance to market the OSSIOfiber® Hammertoe Fixation system.

Medacta Gains FDA Clearance for Mecta-C Stand Alone ACIF Implant

Medacta received FDA 510(k) clearance to market the Mecta-C Stand Alone Implant.

Biogennix Gains Additional FDA Clearance for Agilon Moldable Bone Graft

Biogennix received FDA 510(k) clearance to market Agilon™ moldable bone graft for use in posterolateral spine procedures when mixed with autograft.

Medacta Gains FDA Clearance for Multiple Sports Medicine Products

Medacta received FDA 510(k) clearance to market the MectaLock All-Suture Anchor, MectaTap TI Suture Anchor and Mectafix CL Fixation Button with Continuous Loop.

Life Spine Gains Additional FDA 510(k) for Lateral PROLIFT Expandable System

Life Spine received an additional FDA 510(k) clearance for the Lateral PROLIFT® Expandable System.

Medicrea Gains FDA Clearance for Patient-Matched Interbody Cages

Medicrea was granted FDA 510(k) clearance for UNiD® IB3D Patient-Matched interbody cages.

Paragon 28 Gains FDA Clearance for Phantom ActivCore Nail

Paragon 28 was granted FDA 510(k) clearance to market the Phantom® ActivCore Nail.

Life Spine Gains FDA Clearance of Steerable PLATEAU Ti Interbody

Life Spine gained FDA 510(k) clearance for the Steerable PLATEAU® Ti System.

In2Bones Gains FDA Clearance for Quantum Total Ankle

In2Bones received FDA 510(k) clearance to market the Quantum™ Total Ankle.

Cutting Edge Spine Gains FDA Clearance of EVOLha-DLIF

Cutting Edge Spine received FDA 510(k) clearance of the EVOL®ha-DLIF direct lateral interbody fusion system.

Nextremity Solutions Gains Clearance for Lesser TMT Joint Arthrodesis System

Nextremity Solutions received FDA 510(k) clearance to market the InCore® TMT system, a three-part construct for fixation for Lesser Tarsometatarsal Joint Arthrodesis.

Medacta Gains FDA Clearance for MyShoulder Placement Guides

Medacta was granted FDA 510(k) clearance to market MyShoulder Placement Guides for use with the Medacta Shoulder and associated instrumentation.

Shoulder Innovations Gains Clearance for InSet Plus Augmented Glenoids

Shoulder Innovations received FDA 510(k) clearance to market InSet Plus™ augmented glenoids for the InSet™ Total Shoulder.

OrthoGrid Systems Gains FDA Clearance for Trauma Surgical Imaging Application

OrthoGrid Systems received FDA 510(k) clearance to market a PhantomMSK Trauma application for intraoperative surgical imaging.

LimaCorporate, TechMah Gain FDA Clearance for Smart SPACE Digital Technology

LimaCorporate received FDA 510(k) clearance to market the Smart SPACE Shoulder 3D Planner & 3D Positioner.

Life Spine Gains FDA Clearance for LONGBOW Titanium Spacer

Life Spine was granted FDA 510(k) clearance to market the LONGBOW® Titanium Lateral Expandable Spacer.

NuVasive Gains Additional FDA Clearance for CoRoent Small Interlock

NuVasive received FDA 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system.

Conformis Gains FDA Clearance for Next-Gen Hip

Conformis received FDA 510(k) clearance for a next-generation Conformis Hip System.

DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial

DiFusion received FDA 510(k) clearance for the Xiphos-ZF spinal interbody device made from ZFUZE biomaterial. Product launch will occur within 4Q19.

Stryker Gains FDA Clearance for SAHARA Lateral 3D Expandable Interbody

Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.

Implanet Gains FDA Clearance for MADISON Total Knee

Implanet received FDA 510(k) clearance to market the cemented version of its Madison total knee.

Nanovis Gains FDA Clearance for Bioceramic Nanotube Surface

Nanovis received the first FDA 510(k) clearance for a bioceramic nanotube surface that demonstrates FDA's requirements for nanotechnology.

CarboFix Gains FDA Clearance for Carbon Fiber VBR

CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber Vertebral Body Replacements.

THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application

THINK Surgical received FDA 510(k) clearance to market the TSolution One® Total Knee Application for pre-surgical planning.

Aegis Spine Gains FDA Clearance for AccelFix Expandable Cage

Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage System.

Turner Imaging Gains FDA Clearance for Smart-C Mini-C Arm

Turner Imaging Systems received FDA 510(k) clearance to market the Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.

Back 2 Basics Gains FDA Clearance for Carbon Interbody Cages

Back 2 Basics received FDA 510(k) clearance to market eCarbon anterior cervical and posterior lumbar Interbody devices.

DeGen Medical Gains New FDA Clearances

DeGen Medical received FDA clearance to market the F1 MPS Modular Pedicle Screw System for JOUST Minimally Invasive Surgery and the Cyclops Anterior Cervical Plate.

SpineWelding Gains FDA Clearance for Elaris Pedicle Screw

SpineWelding received its first FDA 510(k) clearance, addressing the Elaris Pedicle Screw.

Life Spine Gains FDA Clearance for Hinged Laminoplasty System

Life Spine was granted FDA 510(k) clearance to market a Hinged Laminoplasty System.

Brainlab’s Cirq Robotics Gains FDA Clearance for Spine

Brainlab received FDA 510(k) clearance to market Cirq® Robotics in the U.S. for spinal applications.

CarboFix Gains FDA Clearance for Carbon Fiber Fenestrated Screw

CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber fenestrated pedicle screws to treat spinal tumors.

Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA Cervical VBR

Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement.

Viseon Gains FDA Clearance for Voyant Imaging for MIS Spine

Viseon announced FDA 510(k) clearance and initial clinical use of Voyant high-definition real-time imaging technology for minimally invasive spine surgery.

OrthoSpin Gains FDA Clearance for Robotic ExFix System

OrthoSpin received FDA 510(k) clearance to market its smart robotic external fixator.

Zimmer Biomet Receives FDA Clearance of JuggerStitch Meniscal Repair

Zimmer Biomet was granted FDA 510(k) clearance for the JuggerStitch device for meniscal repair.

Arthrosurface Gains FDA Clearance for BOSS Toe Fixation

Arthrosurface received FDA 510(k) clearance to market the BOSS Toe Fixation system, a motion-preserving alternative to toe fusion.

4WEB Receives FDA Clearance for Cervical Stand Alone System

4WEB received FDA 510(k) clearance for its Cervical Spine Truss System-Stand Alone interbody.

aap Implantate Gains FDA Clearance for LOQTEQ VA Calcaneus Plates

aap Implantate received FDA 510(k) clearance to market LOQTEQ® variable angle calcaneus plates 3.5 to treat heel fractures.

OrthoPediatrics Gains FDA Clearance for PediFoot Deformity Correction

OrthoPediatrics received FDA 510(k) clearance to market the PediFoot Deformity Correction system. Product launch is slated for 3Q19.

Cutting Edge Spine Gains FDA Clearance of EVOL-SI Joint Fusion

Cutting Edge Spine received FDA 510(k) clearance to market EVOL-SI, a sacroiliac joint fusion system.

Medicrea Gains FDA Clearance of TULIP GENESIS Top loading Screw

Medicrea received FDA clearance to market the TULIP GENESIS top loading screw, the final element in its UNiD ASI spine surgical planning platform.

MiRus Gains FDA Clearance for CYGNUS Anterior Cervical Plate

MiRus received FDA 510(k) clearance to market the molybdenum alloy-based CYGNUS Anterior Cervical Plate.

Life Spine Gains Additional FDA 510(k) Clearance for PROLIFT Expandable Spacer

Life Spine received an additional 510(k) market clearance from FDA for the PROLIFT® Expandable Spacer System, addressing new sizes.

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.

OrthoPediatrics Gains FDA Clearance for Next-Generation Cannulated Screw

OrthoPediatrics received FDA 510(k) clearance to market its next-generation Cannulated Screw to treat smaller stature patients.

MiRus Receives FDA 510(k) Clearance for GALILEO Spine Alignment Monitoring System

MiRus received FDA 510(k) clearance for the GALILEO Spine Alignment Monitoring System.

aap Gains FDA Clearance for LOQTEQ VA Plates

aap Implantate received FDA 510(k) clearance to market LOQTEQ® VA foot plates 2.5. Launch will commence in 2020.

icotec Gains FDA Clearance for VADERone Pedicle Screw

icotec was granted FDA 510(k) clearance for VADER®one pedicle screws for minimally invasive and open spine procedures.

Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody

Benvenue Medical received FDA 510(k) clearance for the Luna® XD MIS expandable interbody device. Controlled launch will proceed at select centers.

Innovasis Gains FDA Clearance of LxHA Spinal Fusion System

Innovasis was granted FDA 510(k) clearance to market the LxHA Lateral Interbody Fusion Device.

Life Spine Gains FDA Clearance for PROLIFT Lateral Expandable Spacer

Life Spine received FDA 510(k) clearance to market the PROLIFT® Lateral Expandable Spacer system.

Aidoc Gains FDA Clearance for AI in Spinal Fracture Detection

Aidoc was granted FDA 510(k) clearance to market an artificial intelligence solution to triage cervical spine fractures.

Zavation Receives FDA Clearance for Ti3Z Interbody

Zavation received FDA 510(k) clearance to market the Ti3Z lumbar interbody system.

Ignite Orthopedics Gains FDA Clearance for Radial Head Arthroplasty System

Ignite Orthopedics received FDA 510(k) clearance to market a Radial Head Arthroplasty System, its first product to be cleared.

Metalogix Gains FDA Clearance for Revolution External Plating System

Metalogix received FDA 510(k) clearance for the Revolution External Plating open ring fixation system.

Misonix Gains FDA Clearance for Nexus Ultrasonic Surgical Platform

Misonix received FDA 510(k) clearance to market the Nexus surgical platform, including BoneScalpel ultrasonic bone cutting technology.

AMDT Gains FDA Clearance for SixFix Hexapod External Fixator

AMDT Holdings received FDA 510(k) clearance to market SixFix, a hexapod external fixation device.

Launch of ControlRad Trace Radiation Reduction Technology for Mobile C-Arms

ControlRad launched ControlRad Trace for mobile C-arms, technology that can reduce unnecessary radiation up to 89% during fluoroscopic imaging.

ChoiceSpine Gains FDA Clearance for Two Cervical Spinal Fusion Devices

ChoiceSpine received FDA 510(k) clearance to market the TIGER SHARK C interbody device and the BOOMERANG Anterior Cervical Plate.

Tenex Health Gains FDA Clearance for TX-Bone

Tenex Health received FDA 510(k) clearance to market TX®-Bone ultrasonic technology to remove bone and calcific tissue.

Treace Medical Gains FDA Clearance for Lapiplasty in Pediatric Patients

Treace Medical Concepts received FDA clearance to expand indications of the Lapiplasty® 3D Bunion Correction system to treat pediatric patients.

Artoss Gains FDA Clearance of NanoBone SBX Putty for Standalone Use in Fusion

Artoss gained FDA 510(k) clearance to market NanoBone® SBX Putty for standalone use in posterolateral spinal fusion.

Konica Minolta Healthcare Gains FDA Clearance for Dynamic Digital Radiography

Konica Minolta Healthcare Americas received FDA 510(k) clearance to market Dynamic Digital Radiography enhanced x-ray imaging that can capture movement in a single exam.

Regulatory Report: 42 Companies that Received their First Orthopedic-Related FDA 510(k) in 2018

Small companies around the world continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or first FDA 510(k) in a new market segment. The companies and products we mention here are excerpted from chapters of the upcoming 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.

Medicrea Gains Additional FDA Clearance for Surgical Planning Software

Medicrea enhanced the UNiD ASI (Adaptive Spine Intelligence) platform with addition of a device selection and surgical planning service, integrating a complete database of all Medicrea spine implants.

SI-BONE Gains FDA Clearance of iFuse Bedrock Fixation Technology

SI-BONE received an additional FDA 510(k) clearance for use of iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.

Collagen Matrix Gains FDA Clearance for Bioactive Moldable Bone Graft Matrix

Collagen Matrix received FDA 510(k) clearance to market OssiMend® Bioactive Moldable Bone Graft Matrix.

Nextremity Solutions Gains FDA Clearance for Stratum Foot Plating

Nextremity Solutions received FDA 510(k) clearance to market Stratum, a comprehensive system of plates indicated for fixation of small bones and bone segments in the foot.

ChoiceSpine HAWKEYE Ti VBR Cleared for All Spine Segments

ChoiceSpine received expanded FDA 510(k) clearance for the HAWKEYE Ti vertebral body replacement for use in the cervical spine.

MiRus Gains FDA Clearance for Molybdenum Rhenium Pedicle Screw

MiRus received FDA 510(k) clearance for the Europa pedicle screw made of MoRe® molybdenum rhenium superalloy material.

SpineEX Receives Additional FDA Clearance for Sagittae LLIF

SpineEX gained additional FDA clearance for the Sagittae Lateral Lumbar Interbody Fusion system, covering new instrumentation and an updated surgical technique.

Zimmer Biomet Gains FDA Clearance of ROSA ONE Spine System for Robotically-Assisted Surgeries

Zimmer Biomet received FDA 510(k) clearance to market the ROSA® ONE Spine System for robotically-assisted spine procedures.

Atreon Orthopedics Receives FDA Clearance for Rotator Cuff Regeneration Device

Atreon Orthopedics received FDA 510(k) clearance to market the Rotium Bioresorbable Wick for the treatment of rotator cuff injuries.

Implanet Gains FDA Clearance for JAZZ Cap

Implanet received FDA 510(k) clearance to market JAZZ Cap® to secure screws in poor quality bone in vertebral fusion procedures.

Exactech Gains FDA Clearance for Alteon Cup and XLE Liner

Exactech received FDA 510(k) clearance to market the Alteon® Acetabular Cup and XLE® Liner for hip reconstruction.

Nvision Gains FDA Clearance for PEEK Hammertoe System

Nvision Biomedical Technologies received FDA 510(k) clearance to market the Vector Hammertoe Correction System, the first foot/ankle implant made from PEEK.

Kuros Biosciences Gains FDA Clearance for Intervertebral Body Fusion Device

Kuros Biosciences received FDA clearance to market the Kuros TLIF cage.

Maxx Orthopedics Gains FDA Clearance for the Freedom Knee Ultra-Congruent Liner

Maxx Orthopedics received FDA 510(k) clearance to market the Freedom® Ultra-Congruent liner for the Freedom Knee® system.

CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew

CurvaFix was granted FDA 510(k) clearance to market the CurvaFix® Intramedullary Rodscrew for less-invasive pelvic trauma surgery.

OrthoGrid Gains FDA Clearance for PhantomMSK Platform

OrthoGrid Systems received FDA 510(k) clearance to market PhantomMSK distortion adaptation technology for use in orthopedic surgery.

Alphatec Gains FDA Clearance for SafeOp Neuromonitoring

Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.

NuVasive Receives Regulatory Clearances for Bone Transport System

NuVasive received FDA 510(k) clearance and CE Mark approval to market Precice® Bone Transport, an all-internal treatment for segmental bone loss in the tibia and femur.

FDA Clears Next SIG Medical AdvantageRib System

SIG Medical received FDA 510(k) clearance for its enhanced AdvantageRib system for rib fracture repair. Full U.S. launch will occur within 1Q19.

Gramercy Extremity Orthopedics Gains FDA Clearance for GEO Nitinol Staple System

Gramercy Extremity Orthopedics received FDA 510(k) clearance for its GEO® Nitinol Staple for fixation of small bone fragments, osteotomies and joint arthrodesis.

Additive Orthopaedics Gains FDA Clearance for Patient Specific 3D Printed Locking Lattice Plates

Additive Orthopaedics received FDA 510(k) clearance to market Patient Specific 3D Printed Locking Lattice Plates for use in small bones.

OSSIO Gains FDA Clearance for OSSIOfiber Bone Pin

OSSIO received FDA 510(k) clearance to market OSSIOfiber bone pins, made of a bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind.

Zimmer Biomet Gains FDA Clearance for ROSA Knee System

Zimmer Biomet received FDA 510(k) clearance to market the ROSA® Knee System for robotically-assisted total knee replacement.

PeekMed Gains FDA Clearance for Pre-Op Planning Software

PeekMed® received FDA 510(k) clearance to market its 3D pre-operative planning software.

Kuros Gains FDA Clearance for Expanded MagnetOs Putty Indications

Kuros Biosciences was granted FDA 510(k) clearance to market MagnetOs Putty as a standalone bone graft in the extremities and pelvis.

NuVasive Gains FDA Clearance for Monolith Corpectomy

NuVasive received FDA 510(k) clearance to market an expanded indication for the Monolith® corpectomy system in the cervical spine.

United Orthopedic Gains Clearance for E-XPE Hip Liner

United Orthopedic received FDA 510(k) clearance to market the E-XPE vitamin E highly cross-linked polyethylene-based hip liner.

SIG Medical Gains FDA Clearance for AdvantageRib Anterior System

SIG Medical received FDA 510(k) clearance to market the AdvantageRib® intrathoracic and anterior rib plating system.

NuVasive Gains FDA Clearance for COHERE in XLIF

NuVasive received FDA 510(k) clearance for the COHERE® Porous PEEK device in eXtreme Lateral Interbody Fusion.

Spinal Elements Receives Additional FDA 510(k) Clearance for Ti-Bond Coating Technology

Spinal Elements received additional FDA 510(k) clearance for claims related to the macro-, micro- and nano-surface structure of its Ti-Bond® surface coating technology.

Siemens Healthineers Gains FDA Clearance for Cios Spine Mobile C-Arm

Siemens Healthineers received FDA clearance to market Cios Spin, a mobile C-arm that provides interoperative 3D imaging for orthopaedic procedures.

Shoulder Innovations Gains FDA Clearance for InSet Humeral Short Stem

Shoulder Innovations received FDA 510(k) clearance to market the InSet Humeral Short Stem.

Medacta Gains FDA Clearance for Kinematic Knee Alignment

Medacta received FDA 510(k) clearance to market the GMK® Sphere “ Kinematic Alignment surgical technique and technique-specific instruments for total knee arthroplasty.

Innovasive Gains FDA Clearance for DualX Expanding Interbody

Innovasive received FDA 510(k) clearance to market the DualX titanium dual expanding interbody device for lumbar fusion procedures.

Zimmer Biomet Gains FDA 510(k) Clearance for PERSONA Revision Knee

Zimmer Biomet received FDA 510(k) clearance to market the PERSONA® revision knee, featuring patient-specific components.

Centric Medical Gains FDA 510(k) Clearance for SATURN External Fixation System

Centric Medical received FDA 510(k) clearance to market its SATURN external fixation system.

VISEON Gains FDA Clearance for Voyant Surgical Platform

Viseon received FDA 510(k) clearance to market the Voyant System for Minimally Invasive Spine Surgery access, visualization and illumination.

X-Bolt Orthopaedics Gains FDA Clearance for Hip Nailing and Hip Plating

X-Bolt Orthopaedics achieved FDA 510(k) clearance for X-Bolt Hip Nailing and Hip Plating fixation.

Medacta Gains FDA Clearance, Announces First U.S. Procedure for Hip Implants

Medacta received FDA 510(k) clearance to market its Mpact 3D Metal and Augments 3D Metal implants for use in total and revision hip arthroplasty.

K2M Expands MESA Platform with FDA Clearance for Sagittal Imbalance Application

K2M received additional FDA 510(k) clearance for the MESA® Spinal System, supporting use of sagittal plane correction in idiopathic scoliosis.

SpineEX Gains FDA Clearance for Sagittae LLIF

SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar interbody fusion.

FDA Approves Update of Mobi-C Cervical Disc Labeling to Include 7-Year Clinical Results

FDA approved an update to the labeling for Zimmer Biomet's Mobi-C® Cervical Disc to include 7-year clinical results, showing the device to be statistically non-inferior in overall study success for 1-level use and statistically superior in overall study success for 2-level use.

Baxter Receives FDA Clearance for ALTAPORE Bone Graft

Baxter was granted FDA 510(k) clearance to market ALTAPORE Bioactive Bone Graft as an autograft extender in posterolateral spinal fusion.

Renovis Surgical Receives FDA Clearance for Tesera X Lateral Interbody Fusion System

Renovis Surgical received FDA 510(k) clearance to market the Tesera® X Lateral Interbody Fusion system.

Alphatec Gains FDA Clearance for OsseoScrew

Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw.

OrthoXel Gains FDA Clearance for Apex Femoral Nail

OrthoXel received FDA 510(k) clearance to market the Apex Femoral Nailing System.

Stryker Gains FDA Clearance for SpineJack Fracture Reduction

Stryker received FDA 510(k) clearance for the SpineJack® implantable reduction system to treat osteoporotic vertebral compression fractures.

Synergy Biomedical Gains FDA Clearance of BIOSPHERE FLEX Graft

Synergy Biomedical received FDA 510(k) clearance to market BIOSPHERE® FLEX bone graft.

Synergy Biomedical Launches BIOSPHERE MIS PUTTY

Synergy Biomedical received FDA 510(k) clearance and commenced full launch of BIOSPHERE® MIS PUTTY for open, mini-open and percutaneous minimally invasive procedures.

b-ONE Ortho Gains FDA Clearance for Total Hip

b-ONE Ortho received FDA 510(k) clearance to market the b-ONE cementless total hip system.

Meditech Spine Gains FDA Clearance for Cure Opel-C Plating System

Meditech Spine gained FDA 510(k) clearance to market the CURE Opel-C Plate implant system, an add-on technology to its CURE anterior cervical plate system and Talos-C HA interbody systems.

SpineVision Gains FDA Clearance, CE Mark for HEXANIUM TLIF Cage

SpineVision received FDA (510)k clearance and CE Mark approval for the 3D-printed HEXANIUM TLIF cage.

IlluminOss Medical Gains FDA Clearance to Expand Trauma Indications

IlluminOss Medical received additional FDA clearance for the IlluminOss Bone Stabilization System to treat impending and pathological fractures.

Captiva Spine Gains FDA Clearance for TowerLOX-EXT Tab Pedicle Screws

Captiva Spine announced FDA 510(k) clearance for the TowerLOX-EXT® MIS Extended Tab pedicle screw.

Genesys Spine Gains FDA Clearance for AIS-C Interbody System

Genesys Spine announced FDA 510(k) clearance and launch of the AIS-C Stand-Alone interbody system for cervical spine.

Baxter Gains FDA Clearance for Bone Graft Substitute

Baxter International received FDA 510(k) clearance for its Actifuse Flow bone graft substitute.

Captiva Spine Gains FDA Clearance for TirboLOX-L Cage

Captiva Spine announced FDA 510(k) clearance and launch of the TirboLOX-L 3D-printed titanium lumbar cage.

Eden Spine Gains FDA Clearance for SPHYNX Thoracolumbar Plate

Eden Spine received FDA 510(k) clearance to market the SPHYNX thoracolumbar locking plate.

Ceterix Orthopaedics Gains FDA Clearance of Size 0 Suture Cartridge

Ceterix Orthopaedics received FDA 510(k) clearance of a size 0 suture cartridge for use with the NovoStitch® Pro Meniscal Repair System.

Osseus Fusion Gains FDA Clearance for 3D-Printed Lumbar IBFs

Osseus Fusion Systems received FDA 510(k) clearance to market Aries 3D-printed lumbar interbody fusion devices.

CoreLink Gains FDA Clearance for Foundation 3D ALIF

CoreLink received FDA 510(k) clearance to market the Foundation 3D Anterior Lumbar Interbody Fusion device.

Field Orthopaedics Gains FDA Clearance for 1.5mm Micro Screw

Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm.

OrthoPediatrics Announces Expanded Indication for FIREFLY Pedicle Screw Navigation

OrthoPediatrics announced an additional FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide to include S2AI screw trajectory for sacral-iliac fixation in complex spinal reconstruction.

NuVasive Gains FDA Clearance for Pulse Surgical Automation

NuVasive received FDA 510(k) clearance to market Pulse surgical automation, the foundation for the company's Surgical Intelligence system.

CarboFix Gains FDA Clearance for Pedicle Screw

CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological patients.

FBC Device Gains FDA Clearance for Interbody Implant

FBC Device received its first FDA 510(k) clearance, granted for the FBC 921 ALIF interbody implant.

K2M Gains FDA Clearance, CE Mark Approval for CAYMAN United Plate

K2M received FDA 510(k) clearance and CE Mark approval for the CAYMAN® United Plate.

Vallum Gains FDA Clearance of Nanotextured PEEK Interbody

Vallum received FDA 510(k) clearance to market a PEEK interbody fusion device with a PEEKplus® nanotextured surface created with proprietary Accelerated Neutral Atom Beam technology.

Cutting Edge Spine Gains FDA Clearance for EVOL ha-C Interbody

Cutting Edge Spine received FDA 510(k) clearance to market the EVOL ha-C cervical interbody system.

Arthrosurface Gains FDA Clearance of Patellofemoral WaveKahuna System

Arthrosurface gained FDA 510(k) clearance to market the Patellofemoral WaveKahuna Arthroplasty System.

Corin Gains FDA Clearance for Trinity PLUS Cup

Corin received FDA 510(k) clearance to market the Trinity PLUS acetabular cup.

Lipogems Gains FDA Clearance for Adipose Tissue Transplant

Lipogems received FDA 510(k) clearance to market a Microfragmented Adipose Tissue Transplant system for use in orthopaedic and arthroscopic procedures.

Renovis Surgical Gains FDA Clearance for New Tesera ALIF System

Renovis Surgical Technologies received FDA 510(k) clearance to market Tesera® SA Hyperlordotic ALIF, a standalone interbody fusion system.

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here's what I found.

Tenon Medical Gains FDA Clearance for Catamaran Sacroiliac Joint Fixation

Tenon Medical received FDA 510(k) clearance to market the Catamaran Sacroiliac Joint Fixation system, indicated for sacroiliac joint fusion to treat joint disruptions and degenerative sacroilitis.

Medtronic’s Kyphon Cement Cleared for Sacral Fracture

Medtronic gained FDA 510(k) clearance for Kyphon HV-R Bone Cement for use in sacroplasty.

Arcuro Medical Gains FDA Clearance for SuperBall Meniscus Repair

Arcuro Medical received FDA 510(k) clearance to market its SuperBall all-suture meniscus repair system for the knee.

Medacta Gains FDA Clearance for Short Humeral Diaphysis

Medacta received FDA 510(k) clearance for a Short Humeral Diaphysis used with the Medacta Shoulder System.

Wright Medical Gains FDA Premarket Approval for AUGMENT Injectable Bone Graft

Wright Medical received FDA premarket approval for AUGMENT® Injectable Bone Graft, serving as an alternative to autograft in hindfoot and ankle fusion.

Centinel Spine Gains FDA Clearance of FLX 3D Printed Titanium Interbodies

Centinel Spine received FDA 510(k) clearance to market the FLX platform of Integrated Interbody and non-integrated interbody fusion devices.

EOS imaging Gains FDA Clearance for hipEOS 3.0 Software

EOS imaging received FDA 510(k) clearance to market hipEOS 3.0 surgical planning software for THA.

Diamond Orthopedic Announces FDA Clearance for Sterile Faceted Screw

Diamond Orthopedic received FDA 510(k) clearance for sterile packaged faceted bone screws.

Spineology Rampart One Standard ALIF Interbody Gains Standalone FDA Clearance

Spineology received FDA 510(k) clearance to market the Rampart One Standard ALIF device without supplemental fixation.

Camber Spine Gains FDA Clearance for ENZA-A Titanium ALIF

Camber Spine received FDA 510(k) clearance to market the ENZA-A Titanium Anterior Lumbar Interbody Fusion system.

Medicrea Gains FDA Clearance for Patient-Specific Spinal Cage

Medicrea obtained what is reported to be the first FDA 510(k) clearance to market patient-specific spinal cages.

K2M Receives FDA Clearance for BACS Patient-Specific Module

K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices.

Zimmer Biomet Gains 510(k) Clearance for Zyston Strut Open Titanium Interbody Spacer

Zimmer Biomet received FDA 510(k) clearance to market the Zyston® Strut Open Titanium Interbody Spacer, the company's first 3D-printed titanium spinal implant.

Life Spine Gains FDA Clearance for PRO-LINK Ti Stand-Alone Cervical Spacer

Life Spine received FDA 510(k) clearance to market additional indications for the PRO-LINK® Ti Stand-Alone Cervical Spacer.

Providence Medical Technology Gains FDA Clearance for DTRAX Spinal System

Providence Medical Technology announced FDA 510(k) clearance to market its DTRAX® system for use in posterior cervical fusion.

Xtant Medical Expands Cervical Portfolio with First Porous Titanium Implant

Xtant Medical received FDA 510(k) clearance for its InTice-C Porous Titanium Cervical Interbody System.

Additive Orthopaedics Gains FDA Clearance of Patient Specific 3D Printed Bone Segments

Additive Orthopaedics received FDA 510(k) clearance to market Patient Specific 3D-Printed Bone Segments for ankle and foot fixation.

OrthoPediatrics Announces FDA Clearance for Femur Nailing Platform

OrthoPediatrics received FDA 510(k) clearance to market its Pediatric Nailing Platform | FEMUR.

CurveBeam Receives FDA Clearance for LineUP Extremity CT System

CurveBeam received FDA 510(k) clearance to market its LineUP multi-extremity CT System.

Nextremity Solutions Gains FDA Clearance For Lapidus Procedure

Nextremity Solutions received FDA 510(k) clearance to market the InCore Lapidus system for forefoot fusion.

Medtronic Gains FDA Approval for INFUSE with Additional PEEK Implants

Medtronic gained FDA approval for use of Infuse bone graft with additional PEEK-based implants in oblique lateral and anterior lumbar interbody fusion procedures at one level.

Meditech Spine Gains Additional FDA Clearance for CURE Lumbar Plate

Meditech Spine received FDA 510(k) clearance for CURE Lumbar Plating iView and QMax, with new sizing options to complement the company's existing CURE system.

Arthrosurface Gains FDA Clearance for OVOMotion Stemless Total Shoulder

Arthrosurface received FDA 510(k) clearance to market OVOMotion, a stemless total shoulder arthroplasty system to treat damage from arthritis, trauma or Avascular Necrosis.

Ceterix Orthopaedics Gains FDA Clearance for NovoStitch Pro Meniscal Repair

Ceterix Orthopaedics received FDA 510(k) clearance to market its next-generation NovoStitch® Pro Meniscal Repair system.

CTL Gains FDA Approval for Seurat Pedicle Screw

CTL Medical gained FDA 510(k) clearance to market the SEURAT Universal Pedicle Screw. The product is slated for 2H18 launch.

Nanovis Gains FDA Clearance of FortiCore Interbodies with Nanosurface Technology

Nanovis received FDA 510(k) clearance to market FortiCore® interbody fusion devices that feature a Nanosurface-enhanced porous titanium scaffold, intermolded with a PEEK core.

Orthofix Gains FDA Clearance of G-Beam Fusion Beaming System

Orthofix received FDA 510(k) clearance to market the G-Beam Fusion Beaming system to treat neuropathic deformities such as Charcot foot.

Exactech Granted FDA Clearance for Vitamin E Acetabular Polyethylene Liner

Exactech received FDA 510(k) clearance to market Novation XLE Vitamin E acetabular polyethylene liners for hip replacement.

Life Spine Gains FDA Clearance of PLATEAU-LO Insert and Rotate Spacer

Life Spine received FDA 510(k) clearance to market the PLATEAU®-LO Insert and Rotate Spacer system for lumbar interbody fusion.

Orthopedic Designs Gains FDA Clearance for Talon DistalFix Humeral Nail

Orthopedic Designs North America received FDA 510(k) clearance for the Talon® DistalFix® Humeral Nail.

CTL Medical Gains FDA Clearance for MATISSE Ti-PEEK ACIF Cage

CTL Medical received FDA 510(k) clearance for the MATISSE Ti-PEEK ACIF cage, featuring TiCro surface technology.

Exactech Receives FDA Clearance for Equinoxe Stemless Shoulder

Exactech received FDA 510(k) clearance to market the Equinoxe® Stemless Shoulder for total shoulder arthroplasty.

Panther Orthopedics Gains FDA Clearance for PUMA Fixation Device

Panther Orthopedics received FDA 510(k) clearance to market PUMA, a flexible system indicated for various foot/ankle repair applications.

Orthofix Gains FDA and CE Mark Approvals for PhysioStim

Orthofix gained FDA premarket and CE Mark approval for next-gen PhysioStim bone growth stimulators, used as a nonsurgical treatment for nonunion fracture in the extremities.

Globus Medical Unveils FDA-Cleared Trauma Products

Globus Medical debuted its FDA-510(k)-cleared trauma products, comprising fracture plates, compression and cannulated screws, intramedullary nails and external fixation.

Amedica Receives FDA Clearance of Valeo C+CsC

Amedica announced FDA 510(k) clearance of the Valeo C+CsC with Lumen interbody fusion device.

Emerging Implant Technology Gains FDA Approval for Multilevel Cervical Cage

Emerging Implant Technologies gained expanded FDA clearance to market EIT Cellular Titanium® Cervical Cages for multiple contiguous levels.

Orthofix Gains FDA Clearance for FORZA XP Expandable Spacer

Orthofix received FDA 510(k) clearance to market the FORZA® XP Expandable Spacer for posterior and transforaminal lumbar interbody fusion.

Centric Medical Gains FDA Clearance of the Foot/Ankle Plate

Centric Medical received FDA 510(k) clearance for a new foot and ankle plating system for calcaneal slide osteotomy and metatarsal phalangeal, lapidus and midfoot fusion.

Centric Medical Gains FDA Clearance for Cannulated Screw in Foot/Ankle

Centric Medical received expanded FDA 510(k) clearance to market its Cannulated Screw Internal Fixation System in foot/ankle reconstruction.

OrthoXel Gains FDA Clearance, CE Mark Approval for Apex Tibial Nail

OrthoXel gained both FDA 510(k) clearance and CE Mark approval for the Apex Tibial Nailing system.

ReBOSSIS Bone Scaffold Gains FDA Clearance in Spine

ORTHOReBIRTH USA received FDA 510(k) clearance to market ReBOSSIS® biosynthetic bone scaffold for use in posterolateral spine procedures.

Zimmer Biomet Gains FDA Clearance for Sidus Stem-free Shoulder

Zimmer Biomet received FDA 510(k) clearance for the Sidus® Stem-Free total shoulder. The device will launch within 1Q18.

NuVasive Update on COALESCE, COHERE Interbody Fusion Devices

NuVasive launched COALESCE for Thoracolumbar Interbody Fusion, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion device with expanded indications.

Anika Gains FDA Clearance for HA-based Bone Void Filler

Anika Therapeutics received FDA 510(k) clearance to market a resorbable, injectable hyaluronic acid-based bone void filler.

Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA VBR

Omnia Medical received FDA 510(k) clearance to market its PEEK-OPTIMA HA-based vertebral body replacement device.

Camber Spine Gains FDA Clearance for Spira-C Open Matrix Cervical Interbody

Camber Spine received FDA 510(k) clearance to market the SPIRA™-C Open Matrix cervical interbody fusion device.

In2Bones Gains FDA Clearance for CoLink View See-Through Plate

In2Bones USA received FDA 510(k) clearance to market CoLink® View see-through plates for the CoLink forefoot bone plating system.

SeaSpine Gains FDA Clearance for OsteoBallast DBM in Resorbable Mesh

SeaSpine received FDA 510(k) clearance to market OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh.

Medicrea Gains FDA Clearance for 3D-Printed Ti Interbody

Medicrea received FDA 510(k) clearance to market IB3D™ 3D-printed interbody devices, and introduced its AdapTEK™ in-house additive manufacturing technology.

Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair

Mortise Medical received FDA 510(k) clearance to market the SyndesMetrics' Syndesmosis Repair system.

MedShape Receives FDA Clearance for DynaNail XL

MedShape received FDA 510(k) clearance to market the DynaNail® XL tibiotalocalcaneal fusion system.

Extremity Medical Receives FDA Clearance for Omni MTP Fusion

Extremity Medical received FDA 510(k) clearance for the Omni MTP fusion system.

DT MedTech Receives FDA Clearance for Hintermann Total Ankle

DT MedTech received FDA 510(k) clearance to market the Hintermann Series H2™ Total Ankle, a semi-constrained, cemented prosthesis for primary or revision surgery.

IntraFuse Receives FDA Clearance for FlexThread Fibula Pin

IntraFuse received FDA 510(k) clearance to market the FlexThread™ Fibula Pin system.

intellijoint HIP Cleared for Revision Arthroplasty

Intellijoint Surgical received FDA 510(k) clearance to market intellijoint HIP® navigation for revision procedures.

Prosidyan Launches FIBERGRAFT BG MATRIX for Posterolateral Spinal Fusion

Prosidyan announced FDA 510(k) clearance and commercial launch of FIBERGRAFT BG Matrix, a bone graft substitute for posterolateral spinal fusion.

Medacta Receives FDA Clearance for Anatomic and Reverse Shoulders

Medacta received FDA 510(k) clearance to market Anatomic and Reverse Shoulder components for its modular Medacta Shoulder system. U.S. launch will occur in 1Q18.

ChoiceSpine Receives FDA Clearance for Blackhawk Interbody Fusion Device

ChoiceSpine received FDA 510(k) clearance to market Blackhawk™, an integrated, self-locking anterior cervical fusion device.

Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon Tritanium

Stryker received FDA 510(k) clearance to market the Mako total knee application with Triathlon cementless components.

NuVasive Receives Expanded FDA 510(k) Clearance for TLX Interbody System

NuVasive received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 20° cage, use with allogeneic bone graft and use in additional levels of the spine.

NuVasive Receives Expanded FDA 510(k) Clearance for PRECICE

NuVasive received expanded FDA 510(k) clearance for the PRECICE® limb lengthening system.

Nexxt Spine Gains FDA Clearance for NEXXT MATRIXX Devices

Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices.

ChoiceSpine Granted FDA Clearance for 3D Printed HAWKEYE Ti VBR

ChoiceSpine received FDA 510(k) clearance to market the HAWKEYE Ti vertebral body replacement, its first 3D-printed device.

K2M Receives FDA Clearance for YUKON OCT System

K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine.

Subchondral Solutions Receives FDA Clearance for Fenestrated Cannulated Screws

Subchondral Solutions received FDA 510(k) clearance to market the fenestrated, cannulated S4 Screw System™ to treat osteochondral fractures.

Expanding Orthopedics’ FDA Clearance for FLXfit15 3D-Articulated Expandable Cage

Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 expandable interbody cage.

Providence Medical Receives FDA Clearance for ALLY Posterior Fixation

Providence Medical Technology received FDA 510(k) clearance to market the ALLY™ Posterior Fixation system as an adjunct to fusion in the cervical spine.

HD LifeSciences Launches NanoHive Lumbar Interbodies

HD LifeSciences received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.

Mortise Medical Receives FDA Clearance for LigaMetrics Suture Anchor

Mortise Medical received FDA 510(k) clearance to market the LigaMetrics™ Suture Anchor for ankle injury repair.

Stryker’s 3D-Printed Tritanium C Anterior Cervical Cage Gains FDA Clearance

Stryker Spine received FDA 510(k) clearance to market its 3D-printed Tritanium® C Anterior Cervical Cage.

Xtant Medical Receives FDA Clearance for Expanded Indications of Irix-A

Xtant Medical received FDA 510(k) clearance to market line extensions for the Irix-A standalone interbody spacer.

Implanet Gains FDA Clearance for JAZZ Passer

IMPLANET received FDA 510(k) clearance to market JAZZ™ Passer, a system of spinal instruments and braided band technology.

Spinal Resources’ FDA Clearance of Swedge Pedicle Screw

Spinal Resources received FDA 510(k) clearance to market the Swedge™ Pedicle Screw system.

OMNI Receives FDA Clearance for Robotic Tissue Balancing Device on OMNIBotics Platform

OMNIlife science received FDA 510(k) clearance to market Active Spacer, a robotic tissue balancing device for use with OMNIBotics® robotic-assisted total knee replacement technology.

NuVasive Receives FDA Clearance for MAGEC with RELINE Small Stature

NuVasive received FDA 510(k) clearance for use of redesigned MAGEC® growing rods with the RELINE® Small Stature pediatric deformity fixation system.

Kuros Biosciences Receives Additional FDA 510(k) Clearance for MagnetOs Putty

Kuros Biosciences received FDA 510(k) clearance to market MagnetOs synthetic bone graft putty as an autograft extender in the posterolateral spine.

Globus Medical Receives FDA 510(k) Clearance for Excelsius GPS Robotic System

Globus Medical received FDA 510(k) clearance to market the Excelsius GPS™ robotic guidance and navigation system.

Stryker Spine Receives FDA 510(k) Clearance for Serrato Pedicle Screw

Stryker Spine received FDA 510(k) clearance to market the Serrato™ Pedicle Screw.

Strategic Orthopaedic-related 510(k)s Issued in July 2017: Interbody Focus

Strategic orthopaedic-related 510(k)s issued in July 2017 include: EIT Cellular Titanium Cages (EIT Emerging Implant Technologies), Lumbar Interbody System (HD LifeSciences), Gemini-C Hybrid Cervical Interbody System (Osseus Fusion Systems), LumFuse-TP (Precifit Medical), Anchorman Tibial Ligament Fixation (Summit Medical)

Camber Spine Commences U.S. Launch of SPIRA Open Matrix ALIF

Camber Spine Technologies received FDA 510(k) clearance and commenced U.S. launch of the SPIRA™ Open Matrix ALIF device, manufactured with additive techniques.

Renovis Receives FDA Clearance for 3D-Printed PLIF Systems

Renovis Surgical received FDA 510(k) clearance to market Tesera® 3D-printed posterior lumbar interbody fusion systems.

In2Bones FDA 510(k) Clearance for Extremity Fixation Implants

In2Bones USA received FDA 510(k) clearance for 5MS™ Fracture Repair and CoLag™ Locking Compression Screw systems for extremity repair.

CTL Medical Receives FDA 510(k) Clearance for MATISSE ACIF Cage

CTL Medical received FDA 510(k) clearance to market the MATISSE™ titanium ACIF cage.

Vertera Spine Receives FDA 510(k) for COALESCE PEEK LIF Device

Vertera Spine received FDA 510(k) clearance to market the COALESCE™ interbody fusion device for ALIF, TLIF, PLIF and LLIF procedures.

Trauma and Spine Markets Gain New FDA Clearances

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies entering the U.S. market.

Emerging Implant Technologies Receives FDA Clearance for Interbody Devices

Emerging Implant Technologies received FDA 510(k) clearance for 3D-printed spinal interbody devices to address ALIF, PLIF, TLIF and cervical procedures.

Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices

Strategic orthopaedic-related 510(k)s issued in June 2017 include: Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS); Tranquil Interbody System (Nexus Spine); PHA S1 Spinal System (Phamedica); Total Hip Arthroplasty Device (Responsive Orthopedics/Medtronic); Interbody Fusion System (Spinal Analytics & Geometrical Implant); Channel Cervical Interbody System (Summit Spine); Coalesce Lumbar Interbody Fusion System (Vertera Spine)

510(k) Clearance

Surgalign Gains FDA 510(k) for HOLO Portal Surgical Guidance

VUZE Medical Gains FDA 510(k) for Spinal Surgery Software

Nextremity Solutions Gains FDA 510(k) for Subtalar Joint Fusion

Inspan Gains FDA 510(k) Clearance for Interspinous Plate

VySpine Gains FDA Clearance of VySpan PCT System

NuVasive Gains Clearance for Expanded Use of Attrax Putty

Paragon 28 R3ACT Stabilization System Cleared by FDA

Spinal Simplicity Granted New Indication for Minuteman Spinal Implants

Nextremity Solutions Gains FDA Clearance for Ankle Fusion Plating

Bioventus Gains FDA Clearance for BoneScalpel Access

Paragon 28’s Patient Specific Titanium Talus Spacer Approved by FDA

3D-Side Gains FDA 510(k) for 3D-Cut Patient-Matched Instrument

CoreLink Launches CentraFix Midline Fixation System

FDA 510(k) Clearance for Active Life Scientific Bone Score Measurement ...

Eminent Spine Gains FDA 510(k) for Cervical Standalone System

PrecisionOS Gains FDA 510(k) for InVisionOS Planning Tool with Virtual ...

FDA 510(k) for nView s1 Surgical Navigation

Trice Medical Granted FDA 510(k) for mi-eye 3 needlescope

Naviswiss Gains FDA Clearance for Hip Replacement Planning

Life Spine Gains FDA 510(k) Clearance for ProLift Micro Expandable ...

ChoiceSpine Granted FDA Clearance of Triton SI Joint System

NGMedical Gains FDA 510(k) for AM Titanium Lumbar Interbody BEE ...

Kleiner Device Gains FDA 510(k) for KG2 Interbody System

Anika’s Tactoset Injectable Bone Substitute Now FDA-Cleared for Hardware Augmentation

Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

Royal Biologics Gains FDA 510(k) for Maxx Concentration System

Intelivation Technologies Gains FDA 510(k) for Advantage-C

joimax Gains FDA Clearance to Market EndoLIF Delta-Cage and DoubleWedge-Cage

Radiobotics Gains FDA 510(k) for Knee Osteoarthritis Analysis Tool

In2Bones Receives FDA Clearance for Pre-Surgery OrthoPlanify

Tyber Medical Granted FDA 510(k) Clearance for Anatomical Plating

Intelivation Technologies Gains FDA 510(k) for Golden Isles Pedicle Screw

MiRus Gains FDA 510(k) for IO Expandable Lumbar Interbody

FDA De Novo Classification Grant for Zimmer Biomet Persona IQ ...

Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

Zimmer Biomet Gains FDA Clearance for ROSA Hip System

Globus Medical Announces FDA 510(k) Clearance for Excelsius3D

Auctus Surgical: FDA Breakthrough Device Designation

Camber Spine Gains FDA 510(k) for SPIRA-P and SPIRA-T Technologies

The Orthopaedic Implant Company Launches DRPx Wrist Fracture Plate

Aurora Spine Gains FDA 510(k) Clearance for DEXA-C Cervical Interbody

NuVasive Gains Latest FDA 510(k) for Pulse Platform

ARVIS Augmented Reality Gains FDA 510(k) Clearance

SeaSpine Gains FDA 510(k) Clearance of 7D Surgical Percutaneous Spine ...

Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

Interventional Systems Gains FDA 510(k) for Micromate Head-to-Toe Medical Robot

CoreLink Gains FDA Clearance for F3D Corpectomy System

Onkos Surgical Gains FDA 510(k) Clearance for BioGrip Modular Porous ...

Breakthrough Designation for MIScoli Vertebral Body Tethering

Regulatory Clearances for NEO Pedicle Screw with BonOs Inject Cement

Breakthrough Designation for BONESUPPORT CERAMENT G for Trauma

OXOS Medical Gains FDA Clearance for Micro C in Pediatrics

Vuzix Smart Glasses to Support Shoulder, Knee and Spine Surgeries

Medtronic Gains FDA Clearance for UNiD Patient-Specific Rods with CD ...

Medacta Gains Regulatory Clearances for NextAR Surgical Planning Applications

FDA Clearance for ChoiceSpine Blackhawk Ti Cervical Spacer

Breakthrough Designation for PerQdisc Nucleus Replacement for Degenerative Disc Disease

CUREXO Gains FDA 510(k) Clearance for CUVIS-spine Surgical Robot

Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

Orthofix Gains FDA Clearance of OrthoNext Digital Platform for the ...

FDA Clearance for Balanced Knee System and BKS TriMax Implants ...

Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

Genesis Software Innovations Gains FDA 510(k) Clearance For Preview 3D ...

Paragon 28 Gains FDA 510(k) Clearance for MAVEN Patient-Specific Instrumentation ...

Life Spine Gains FDA 510(k) Clearance for PROLIFT Lateral HELO ...

Next Science Gains FDA 510(k) for Antimicrobial Solution

Pixee Medical Receives FDA Clearance for Knee+

Osteotec Gains FDA 510(k) Clearance for ChiroKlip

Conformis Hits Regulatory Milestone in Agreement with Stryker

Orthofix Gains FDA Clearance for 3D-Printed FORZA Titanium TLIF Spacer

Zimmer Biomet Gains FDA Clearance for ROSA Partial Knee

Spinal Elements Gains FDA Clearance of Lucent 3D-Printed Interbodies

Avitus Orthopaedics Gains FDA Clearance for Expanded Indications of Avitus ...

Empirical Spine Receives Breakthrough Device Designation for LimiFlex