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Medtronic Gains 510(k) and Breakthrough Designation for LigaPASS 2.0

LigaPASS is reportedly the first and only FDA-cleared device with an indication for ligament augmentation in spine surgery.

Theradaptive Secures Third FDA Breakthrough Designation

FDA granted Breakthrough Medical Device designation for the use of OsteoAdapt SP in Anterior Lumbar Interbody Fusion.

Altus Spine Granted FDA Clearance for Sochi OCT System

Comprising polyaxial screws, hooks, rods, locking screw assemblies and connectors, Sochi OCT may be rigidly locked to promote fusion for a variety of anatomies.

Novarad Gains 510(k) for AR Surgical Navigation

VisAR, an augmented reality surgical navigation system, is cleared for precision-guided intraoperative spine surgery.

Xenco Medical Expands ASC Device Portfolio

Xenco announced FDA clearance and launch of its Multilevel CerviKit, implants and single-use instruments for 2, 3 and 4 level anterior cervical spine procedures.

SI-BONE Gains Expanded Indication for the iFuse-TORQ Implant

SI-BONE now has FDA clearance for iFuse-TORQ for pelvic fracture fixation, including acute, non-acute and non-traumatic fractures.

Red Point Medical 3D Gains 510(k) for PSI-Based Bunion Surgery

This is reportedly the first instrumentation of its kind cleared by FDA for patient-specific bone cutting guides in foot and ankle reconstructions.

Zavation Medical Receives FDA 510(k) for eZspand Lateral Cage

eZspand Lateral features expandable precision paired with continual expansion to provide an optimized fit for each patient.

FX Gains 510(k) for Shoulder Replacement Platform

The FX V135 platform includes a new-to-market mini stem humeral component that is set at 135° for both the anatomical and reverse configurations.

Medartis Granted 510(k) for CalcShift Displacement Calcaneal Osteotomy System

CalcShift is one of several new lower extremity products that Medartis has scheduled for U.S. launch in 2023.

Aurora Spine Gains FDA 510(k) Clearance for DEXA SOLO-L

The 3D-printed device is part of the bone density-matched implant based on Aurora's patented DEXA Technology Platform.

SMAIO Gains 510(k) for Balance Analyzer 3D Surgery Planning

Balance Analyzer 3D spinal realignment planning software has been an integral part of the i-plan surgical planning solution.

Altus Spine Gains 510(k) for Monaco HA Pedicle Screw

The HA Pedicle Screw is indicated to provide immobilization and stabilization of spinal segments as an adjunct to fusion.

Stryker Gains 510(k) for Q Guidance System for Spine

The planning and intraoperative platform is designed to be a procedural ecosystem for surgeons and their patients during image-guided surgery.

Embody Granted 510(k) Clearances for TAPESTRY RC

TAPESTRY RC addresses rotator cuff repair with a biointegrative collagen plus arthroscopic delivery and fully bioabsorbable fixation.

SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite

The Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundation for segmental spinal fusion procedures.

FDA Market Authorization for BONESUPPORT’s CERAMENT G

FDA granted market authorization for the antibiotic eluting product CERAMENT G, for the indication bone infection (osteomyelitis).

Flow-FX Gains FDA Clearance for Additional Indication

The Flow-Nail with LAGLOCK now has reportedly the first and only through-the-lag screw static locking mechanism.

Anika Receives FDA Clearance for X-Twist Knotless Fixation

X-Twist provides a knotless suture anchor system suitable for repairs in the shoulder, foot and ankle and other extremities.

Accelus Gains FDA Clearance for Toro-L Interbody Fusion

Toro-L was designed to offload the pressure on the innervated posterior psoas muscle without sacrificing footprint.

CTL Amedica Navigation Instrument System Gains FDA 510(k)

The system features instruments adaptable for use with third-party navigation to locate anatomical structures for placement of pedicle screws.

Breakthrough Device Designation for JointMedica’s Polymotion Hip Resurfacing

Exactech is collaborating with JointMedica deliver the next generation of hip resurfacing to the global market.

INHANCE Gains FDA Clearance for Reverse Total Shoulder Replacement

This clearance is in addition to the system's already cleared use in anatomic shoulder arthroplasty.

Accelus Receives 510(k) for FlareHawk TiHawk11 Interbody Fusion

Accelus' FlareHawk portfolio of spinal fusion cages is now available in a larger footprint with titanium at the bony interface.

Osseus Gains 510(k) for Pisces-SA Spinal Fusion

The company has now launched the Pisces-SA Standalone ALIF Interbody System in the U.S.

Orthofix Granted PMA for AccelStim Bone Healing Therapy

AccelStim is indicated to treat fresh fractures and fractures that have not healed.

ExsoMed Gains 510(k) for NanoPhix Cannulated Lag Screw

The screw provides a sterile solution to optimize outcomes of common fracture surgeries such as avulsion, mallet and condylar fractures.

Empirical Spine Submits PMA Module II for Limiflex

LimiFlex is designed to restore natural segmental motion and stability after lumbar decompression by augmenting the posterior tension band.

CoNextions TR Tendon Repair Receives FDA Clearance

CoNextions was granted FDA 510(k) clearance to market the CoNextions TR® Tendon Repair System. Expected to launch in May 2022, the novel system addresses traumatic tendon lacerations in the hand, wrist and forearm....

Nexxt Spine Gains 510(k) for Navigation Compatible Instrumentation

The system comprises specialized screw drivers, bone taps and awls compatible with the Inertia Pedicle Screw, as well as future development programs.

Kuros Biosciences Gains Clearance for MagnetOs Flex Matrix

MagnetOs Flex Matrix bone graft is cleared by FDA as a bone void filler for use in the posterolateral spine.

Orthopaedic Implant Company Launches Dorsal Spanning Plate

This latest trauma offering expands the utility of DRPx, the company's high-value wrist fracture plating system.

ODi NA Gains FDA Clearance for Cannulated Compression Device

The device is the first modular cannulated screw to use ODi's Talon Technology to treat both small and large bone fractures.

SpineUp Gains FDA Clearance for Romero Cervical Cages

Romero and Romero cervical cages and self-anchored cervical cages are made of PEEK Optima HA-Enhanced to support osteointegration.

FDA Approves CartiHeal’s Agili-C Implant

Approval is based on results of a clinical study that demonstrated superiority of Agili-C to debridement and microfracture in the knee joint.

Life Spine Gains Additional 510(k) Clearance for SImpact SI Joint Fixation

The additional clearance supports use of the system in Posteror-Oblique approaches to sacroiliac joint fixation.

OSSIO Granted Additional FDA Clearance for OSSIOfiber Implants

OSSIOfiber Intelligent Bone Regeneration Technology is an implant material, stronger than cortical bone, that leaves nothing permanent behind.

FDA Clearance for Lazurite’s ArthroFree Wireless Camera

ArthroFree is reportedly the first wireless camera system for minimally invasive surgery to be cleared by FDA for marketing and sale.

MicroPort Orthopedics Granted Marketing Approval in China for Two Knee Systems

The company received NMPA registration certificates for two independently developed knee system products, SoSuperior+ and MedalOne.

3D-Side Gains FDA Clearance for Joint Replacement Planning

The additional clearance allows physicians to use the processing software to pre-plan shoulder joint replacement.

Orthofix Gains FDA Clearance for TrueLok EVO Ring Fixation

Designed for complex limb reconstruction and deformity correction, the system features radiolucent rings and struts for clear visualization under x-ray.

Shoulder Innovations Receives FDA Clearance for InSet Stemless Humeral Implant

InSet Stemless is the latest addition to the InSet shoulder system, which includes Glenoid, Humeral Short Stem and Reverse components.

Carbon22 Gains FDA 510(k) for Apollo Ankle Plates

Apollo Ankle Fracture Plating comprises see-through, ortholucent bone plates and screws used for orthopedic ankle fracture surgery.

L&K Biomed Granted FDA Clearance for Expandable Interbody

PathLoc is a next-generation height-expandable spinal implant product for the treatment of spinal diseases.

VySpine Granted FDA Clearance for LumiVy Lumbar Interbody Fusion

LumiVy Lumbar IBF features lumbar interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced.

CoreLink Gains FDA Clearance for Fusation Cervical Anchors

CoreLink Fusation anchors are additively manufactured and designed for robust fixation and bony attachment in challenging anterior cervical fusions.

GLEAMER Granted FDA Clearance for AI Fracture Detection

BoneView AI software is designed to aid in the diagnosis of fractures and traumatic injuries on x-rays.

FDA Clearance for SurGenTec ION Spinal Fixation

SurGenTec's ION Screw is the smallest posterior spinal fixation implant to enter the market.

Nvision Biomedical FDA Clearance for Trigon Wedges

These wedges are the fifth and sixth medical devices cleared by Nvision utilizing PEEK-OPTIMA HA Enhanced.

Gramercy Extremity Orthopedics Gains FDA Clearance on Newest Plating Lines

These new plates integrate with GEO's current system, utilizing the same single-use sterile instrument kits and screws that are brought to market with the GEO Cart.

Theradaptive Granted Breakthrough Device Designation

This is the second Breakthrough Designation for Theradaptive in spinal fusion, granted for the OsteoAdapt SP implant.

Bonalive Granules Gain Breakthrough Device Designation

Proposed indications include filling of bony voids and gaps, and protecting against microbial colonization while granules resorb and are replaced with bone.

Bone Solutions Gains FDA Clearance for Mg OSTEOREVIVE Spine Magnesium-Based Bone Void Filler

A critical component for bone development, magnesium contains high strength and a modulus of elasticity that closely resembles human bone.

Kuros Biosciences’ MagnetOs Granules FDA-Cleared for Expanded Spinal Indications

This is the second-ever bone graft to achieve clearance for standalone use in the spine based on human clinical data.

AxioMed LLC Files PMA Module II For Viscoelastic Disc

AxioMed's lumbar viscoelastic total disc replacement PMA Module II was submitted to FDA in January 2022.

VySpine Gains FDA Clearance for ClariVy Cervical IBF System

ClariVy Cervical IBF features cervical interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced.

Innovasis Launches 3D-Printed Stand-Alone Titanium ALIF with HAnano Surface

Innovasis is the first company to receive FDA 510(k) clearance for a Stand-Alone ALIF System featuring HAnano Surface.

Magnesium Development Company Gains Breakthrough Device Designation

MDC is developing implants with BioMg 250, an alloy composition that contains a blend of magnesium and other elements.

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.

Ortoma Gains Japan Approval for Surgical Planning System

Ortoma's AI-assisted OTS Hip Plan is designed for pre-op planning of hip replacement surgery.

AxioMed Files 1st PMA Module with Freedom Lumbar Disc

AxioMed's disc replacement device is expected to be only one of three lumbar discs expected to be on the market in 2022.

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 Grants Breakthrough Device Status to Theradaptive

The Osteo-Adapt SP Spinal Fusion implant is indicated for use in transforaminal lumbar interbody spinal fusion.

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.

Breakthrough Device Designation for MY01 Continuous Compartmental Pressure Monitor

AAOS recognizes the use of continuous pressure monitoring to aid in the diagnosis of Compartment Syndrome.

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.

Syntellix Granted Approval to Market Devices in India

The five MAGNEZIX product families introduce magnesium-based devices for orthopedics and trauma applications in the region.

Amber Implants VCFix Granted FDA Breakthrough Designation

VCFix is the first solution to treat vertebral fractures that does not rely on bone cement.

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.

SeaSpine Granted CE Mark for FLASH Navigation

CE Mark approval was granted for the 7D Surgical Cranial Module and Percutaneous Spine Module.

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.

Medacta Expands Hip Revision Portfolio

First cases are complete using the AMIS-K Long, Iliac Screw Mpact 3D Metal and 3D Metal B-Cage, following CE Mark approval.

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.

Biocomposites Gains Approval for STIMULAN to Treat Bacterial Infection

STIMULAN when mixed with antibiotics is the only calcium matrix approved for treating bacterial infection in soft tissue surrounding bone.

NuVasive Receives Latest CE Mark Approval for Pulse Spinal Platform, Begins Global Clinical Evaluations

Pulse is designed to increase efficiency and procedural reproducibility, while addressing common clinical challenges in spine 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.

ZygoFix Obtains CE Mark for zLOCK Spinal Fusion

The miniature 3D-printed implant uses the spine's anatomy for spinal stability, rather than traditional external screw-based stabilization.

Integrity Implants Receives CE Mark for FlareHawk Expandable Lumbar Interbody Fusion Device

In addition to receiving FDA clearance and CE Mark approval, FlareHawk has also received clearance in Argentina, New Zealand, Taiwan and the UAE.

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.

Orthobiologics Strategy: FDA Issues New Warning about Sales of Unapproved Products

FDA doubled down on its enforcement commitment for Human Cell and Tissue Products after its enforcement discretion ended in May.

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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.

Turner Imaging Systems Receives CE Mark for Smart-C Mini C-Arm Portable Fluoroscopy X-Ray Imaging

Smart-C offers point-of-care imaging. The design provides surgeons with greater flexibility and superior imaging in a cord-free package.

Safe Orthopaedics Gains CE Mark for Hickory Pedicle Screw

Hickory, the latest addition to the SteriSpine PS range, is designed to improve bone anchorage in osteoporotic patients.

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.

Safe Orthopaedics Granted CE Mark for Sycamore Osteoporotic Fracture Treatment

Sycamore is a minimally invasive, ready-to-use technology that improves the first treatment of one or more fractures.

Prosidyan Gains CE Mark for FIBERGRAFT Bone Grafts

FIBERGRAFT BG Putty, FIBERGRAFT BG Putty GPS and FIBERGRAFT BG Morsels are intended for use in the lumbar and anterior cervical spine.

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.

EDGe Surgical Gains CE Mark for EDG Electronic Depth Gauge

EDG Ortho is a sterile, single-use device used to measure which length screw should be implanted in a fracture procedure.

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.

Cerapedics Gains Breakthrough Device Designation for P-15L Bone Graft for the Treatment of Degenerative Disc Disease

P-15L Bone Graft is part of an IDE study vs. autologous bone graft in TLIF surgery.

Bioretec Receives Breakthrough Device Designation for RemeOs Screws

Bioresorbable RemeOs screws are intended for trauma and orthopedic surgery for fracture fixation and correction of deformities or malalignments.

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.

Ortoma Granted CE Mark for Spine Surgical Planning Software

The OTS platform is assisted by AI for accuracy and efficiency. The current module is a pre-operative planning solution for spine surgery.

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.

AgNovos Healthcare Receives Investigational Device Exemption for Breakthrough Spine Device

The IDE for the AGN1 Local Osteo-enhancement Procedure Small Volume kit will support study of the device to treat vertebral compression fractures.

Hensler Surgical Obtains CE Mark Approval for Hensler Bone Press

The press uses a 2-step technique to harvest autologous material during bony decompressions such as laminectomy, vertebral corpectomy, foot/ankle surgery, etc.

Implanet Gains Regulatory Clearance for MADISON Total Knee in Australia

This approval is part of the distribution agreement with KICo to market MADISON in the U.S. and Australia.

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.

NuVasive’s Simplify Disc Gains FDA Approval for Two-Level Cervical Total Disc Replacement

Simplify achieved the highest overall clinical success rate at both one- and two-levels compared to any other approved cervical disc.

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.

Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

JOYCLU, a combination of hyaluronic acid and an anti-inflammatory drug, is approved for manufacture and marketing in Japan.

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.

Sparta Biomedical Receives FDA Breakthrough Device Designation for SBM-01 Biomimetic Implant

The SBM-01 Biomimetic Implant is intended to replace damaged knee cartilage in single or multiple chondral or osteochondral defects.

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.

FDA Issues Safety Communication on STAR Ankle

The notice relates to a higher than expected risk of fracture in the device's plastic component, as early as 3 to 4 years post-implantation.

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.

Silver Bullet Therapeutics Earns Updated CE Mark for Its Antimicrobial Bone Screw System

Covered in proprietary AntiBacterIon coating, OrthoFuzIon bone screws release sustained silver ions that protect the device and kill bacteria.

Conformis Gains Clearance for iTotal PS Knee in Australia

iTotal PS patient-specific implants fit the size and shape of each patient's knee, and provide stability throughout the full range of motion.

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.

Empirical Spine Begins PMA Submission for Limiflex Band

The LimiFlex Paraspinous Tension Band is an investigational device designed as an alternative to spinal fusion.

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.

Geistlich Pharma Granted FDA Breakthrough Device Designation for Chondro-Gide Articular Cartilage Cover

Chondro-Gide articular cartilage cover is a collagen membrane that is used in a single-step cartilage repair technique.

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.

OrthoPediatrics Expands Product Portfolio in Canada

Available products include Orthex, PNP|FEMUR and PediFoot and features the RESPONSE Scoliosis family.

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.

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

ReNu comprises amniotic fluid cells and micronized amniotic membrane, and contains cellular, growth factor and extracellular matrix components.

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.

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.

DJO Global Emerges as Buyer for Stryker Divestitures

To clear regulatory issues related to its purchase of Wright Medical, Stryker proposed DJO as a buyer for certain ankle and finger joint replacement lines.

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.

CartiHeal Agili-C Granted Breakthrough Device Designation

FDA granted Breakthrough Device Designation for CartiHeal's Agili-C implant™, a cell-free implant for treatment of cartilage and osteochondral defects.

SeaSpine Gains CE Mark for Mariner Outrigger Posterior Fixation

This system offers clinical solutions with diversified implants to support complex revision and extension spine procedures.

Graftys Gains CE Recertification of Bone Void Fillers

Graftys' products are registered in more than 30 countries worldwide, including Europe, the U.S., Canada and South America.

MagnetOs Bone Grafts Approved in Australia

MagnetOs Granules and MagnetOs Putty received TGA approval in Australia. Initial market launch is scheduled for late 1Q21.

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.

CurveBeam Gains CE Mark Approval for HiRise Weight-Bearing CT System for Lower Extremities

Only CurveBeam systems offer a wide platform that lets patients stand naturally during a scan along the lower extremity from the hip & pelvis to the feet.

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.

Simplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA

Study results demonstrated that the Simplify Disc achieved superiority in overall success compared to anterior cervical discectomy and fusion.

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.

Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

Canada will be the first commercial market to launch i-FACTOR+ Matrix. The technology is currently being studied in an FDA IDE trial targeting lumbar fusion.

NovoPedics’ MeniscoFix Granted Breakthrough Device Designation

The designation and funding from the U.S. DoD will accelerate R&D for the mechanically functional total meniscus replacement that is resorbed by the body.

CTL Amedica to Enter Asian Market with Interbody Fusion Devices

The Taiwan Food and Drug Administration has granted CTL Amedica Corporation a license for three silicon nitride spine products.

IZI Medical Gains CE Mark for Kiva VCF Treatment

The Kiva Vertebral Compression Fracture Treatment is a unipedicular PEEK implant-based solution that has seen clinical and commercial success in the U.S.

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.

Smith+Nephew Launching REDAPT Revision Hip in China

The REDAPT System's acetabular components are among the pioneers of 3D-printed, imported, acetabular products approved for use in China.

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.

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.

Cerapedics Gains FDA Approval of IDE Supplement

The IDE Supplement allows for a reduction in the number of patients required to be enrolled in the ASPIRE IDE Study on P15-L bone graft in the lumbar spine.

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.

7D Surgical Gains CE Mark for Spinal Image Guidance System

The company can now offer its Machine-vision Image Guided Surgery system for spine surgery throughout European market and additional global regions.

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.

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.

Smith+Nephew’s REGENETEN Implant Gains CE Mark

REGENETEN supports the body's natural healing response to facilitate new tendon-like tissue growth for rotator cuff repairs.

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.

Implanet Granted CE Mark Renewal for Madison Knee

European authorities extended the CE Mark approvals on the entire range of MADISON knee devices for a further four years.

Rejoint YourKnee Gains Additional CE Mark Approval

Rejoint offers more than 6,300 femoral variations including multiple designs and coatings. FDA 510(k) clearance is expected in 2Q21.

Medacta Gains CE Mark for Shoulder Implants

The two components allow surgeons to widen clinical use of the system by addressing more patient morphologies and pathologies.

Medacta Announces First Surgery with Mecta-C Stand Alone Device and New Registrations

Mecta-C Stand Alone has also obtained CE Mark approval in Australia, and will soon be launched there and select areas in Europe.

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.

Medacta Shares Sports Medicine Product Milestones

Medacta announced CE Marking for multiple sports medicine products and first surgeries using the MectaTap TI Anchor and FastShuttle Suture Passer.

Nextremity Solutions Gains FDA Clearance for Metatarsophalangeal Joint Arthrodesis System

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

Curexo Gains CE Mark Approval for CUVIS-spine Robot

CUVIS-spine guides and supports the pedicle screw to the correct position using a robotic arm, one-step surgical tools and a real-time location sensor.

Bodycad Gains Regulatory Approval in Canada for BC Fine Osteotomy

BC Fine Osteotomy offers a procedural solution adapted to each patient and is delivered as a procedure in a box to drive efficiency in the O.R.

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.

Foresee-X Smart Surgical Glasses Gain CE Mark Approval

The system allows for reduction in the use of external monitors during trauma procedures, thereby minimizing radiation exposure among other benefits.

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.

Pixee Medical Granted CE Mark for Augmented Reality Knee Replacement Navigation

Knee+ technology combines computer vision and deep learning algorithms and works with off-the-shelf AR glasses to track instruments and implants.

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.

FDA Grants Carmell Therapeutics Expedited Review for Bone Healing Accelerant

Carmell will begin enrolling in a pivotal clinical program for Plasma-based Bioactive Material used in long-bone fractures as an adjunctive treatment.

Simplify Medical Completes PMA Submission for 1-Level Simplify Disc IDE

FDA has determined that the premarket approval is complete, and has commenced the filing review for the 1-level cervical disc.

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.

Biocomposites Granted CE Mark for STIMULAN

This represents the first calcium matrix to receive European approval as an antibiotic carrier for use in bone and soft tissue.

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.

FDA Approves Centinel Spine’s Two-Level prodisc L for Total Disc Replacement

The prodisc line now comprises six devices, including an anterior and anterior-lateral approach lumbar disc replacement and four cervical disc implants.

Bodycad Gains FDA Clearance for BC Fine Osteotomy

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

Signus Medizintechnik Gains CE Mark for BIG ST ALIF Cage

Signus Medizintechnik announced CE Mark approval for the BIG® ST ALIF Cage and JASPIS® ST Cervical Cage, additions to the company's Structural Titanum portfolio of 3D-printed cages.

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.

Safe Orthopaedics Gains Japan Approval of Next-Gen SteriSpine PS

Safe Orthopaedics received regulatory approval of SteriSpine™ PS 2nd Generation in Japan.

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.

AgNovos Receives Breakthrough Device Designation for Spine Device

AgNovos Healthcare was granted Breakthrough Device Designation by FDA for the AGN1 Local Osteo-enhancement Procedure Small Volume Kit for the treatment of vertebral compression fractures.

Bone Therapeutics Gains Approval for Studies of OA Knee Pain Therapies

Bone Therapeutics received regulatory approvals for next studies of both of its lead therapeutic candidates to treat osteoarthritic knee pain.

BONESUPPORT to Submit a De Novo Application for CERAMENT G

BONESUPPORT will submit a De Novo application for approval of CERAMENT® G in the treatment of osteomyelitis.

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.

DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility Hip

DePuy Synthes has been informed of CE Mark approval for the BI-MENTUM™ Dual Mobility hip for patients with a higher dislocation risk.

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.

Bioretec Gains CE Mark for Activa IM-Nail, Activa Screw

Bioretec received approval under the CE Mark for two bioresorbable devices, the Activa IM-Nail™ and the ActivaScrew™ Interference TCP screw.

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.

GreenBone Gains CE Mark Approval for Bone Substitute

GreenBone Ortho received approval under the CE Mark for GreenBone Bone Substitute™.

Medacta Announces First Surgeries and CE Marking for Sports Medicine Products

Medacta gained CE Mark approval for several of its sports medicine devices, and marked multiple first sports medicine procedures in Australia and the U.S.

Rejoint YourKnee Receives CE Mark Approval

REJOINT received CE Mark approval for the YourKnee™ patient-specific 3D-printed total knee replacement.

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.

Silver Bullet Therapeutics Gains CE Mark for OrthoFuzIon Bone Screw

Silver Bullet Therapeutics received CE Mark approval for the OrthoFuzIon™ Bone Screw for reduction and internal fixation procedures anywhere in the body.

Episurf Medical receives CE Mark for Episealer Talus and Talus Osteotomy Guide

Episurf Medical received approval under the CE Mark for the Episealer® Talus and Talus Osteotomy Guide.

Carmell Therapeutics Gains IND Application Clearance for Bone Healing Accelerant

Carmell Therapeutics announced FDA clearance of an Investigational New Drug application for the company's Bone Healing Accelerant and enrollment in a pivotal study for long bone fractures.

Naviswiss Gains Japan Regulatory Approval for Hip Navigation

Naviswiss is entering the Japanese market with its miniaturized surgical navigation for hip replacement.

Episurf Medical Patent and Regulatory Updates

Episurf Medical received an additional patent in China relative to the Episealer® Femoral Twin joint implant design process and expects to obtain CE Mark Approval for the Episealer Talus ankle implant.

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.

Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR

FDA approved Cerapedics' Premarket Approval supplement for i-FACTOR® Peptide Enhanced Bone Graft for use in ACDF to treat degenerative cervical disc disease.

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.

Safe Orthopaedics SteriSpine LC and CC Gain Japan Regulatory Approval

Safe Orthopaedics received regulatory approval for SteriSpine™ LC lumbar and CC cervical cages in Japan.

Garwood Medical Granted FDA Breakthrough Device Designation for Biofilm Tool

Garwood Medical Devices was granted a Breakthrough Device designation from FDA for BioPrax™, an electrical stimulation tool to help eliminate biofilm infections on knee implants.

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.

Spineway Mont Blanc MIS Approved in Japan

Spineway obtained regulatory approval in Japan for its Mont Blanc minimally invasive surgical devices.

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.

Regulatory

Medtronic Gains 510(k) and Breakthrough Designation for LigaPASS 2.0

Theradaptive Secures Third FDA Breakthrough Designation

Altus Spine Granted FDA Clearance for Sochi OCT System

Novarad Gains 510(k) for AR Surgical Navigation

Xenco Medical Expands ASC Device Portfolio

SI-BONE Gains Expanded Indication for the iFuse-TORQ Implant

Red Point Medical 3D Gains 510(k) for PSI-Based Bunion Surgery

Zavation Medical Receives FDA 510(k) for eZspand Lateral Cage

FX Gains 510(k) for Shoulder Replacement Platform

Medartis Granted 510(k) for CalcShift Displacement Calcaneal Osteotomy System

Aurora Spine Gains FDA 510(k) Clearance for DEXA SOLO-L

SMAIO Gains 510(k) for Balance Analyzer 3D Surgery Planning

Altus Spine Gains 510(k) for Monaco HA Pedicle Screw

Stryker Gains 510(k) for Q Guidance System for Spine

Embody Granted 510(k) Clearances for TAPESTRY RC

SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite

FDA Market Authorization for BONESUPPORT’s CERAMENT G

Flow-FX Gains FDA Clearance for Additional Indication

Anika Receives FDA Clearance for X-Twist Knotless Fixation

Accelus Gains FDA Clearance for Toro-L Interbody Fusion

CTL Amedica Navigation Instrument System Gains FDA 510(k)

Breakthrough Device Designation for JointMedica’s Polymotion Hip Resurfacing

INHANCE Gains FDA Clearance for Reverse Total Shoulder Replacement

Accelus Receives 510(k) for FlareHawk TiHawk11 Interbody Fusion

Osseus Gains 510(k) for Pisces-SA Spinal Fusion

Orthofix Granted PMA for AccelStim Bone Healing Therapy

ExsoMed Gains 510(k) for NanoPhix Cannulated Lag Screw

Empirical Spine Submits PMA Module II for Limiflex

CoNextions TR Tendon Repair Receives FDA Clearance

Nexxt Spine Gains 510(k) for Navigation Compatible Instrumentation

Kuros Biosciences Gains Clearance for MagnetOs Flex Matrix

Orthopaedic Implant Company Launches Dorsal Spanning Plate

ODi NA Gains FDA Clearance for Cannulated Compression Device

SpineUp Gains FDA Clearance for Romero Cervical Cages

FDA Approves CartiHeal’s Agili-C Implant

Life Spine Gains Additional 510(k) Clearance for SImpact SI Joint ...

OSSIO Granted Additional FDA Clearance for OSSIOfiber Implants

FDA Clearance for Lazurite’s ArthroFree Wireless Camera

MicroPort Orthopedics Granted Marketing Approval in China for Two Knee ...

3D-Side Gains FDA Clearance for Joint Replacement Planning

Orthofix Gains FDA Clearance for TrueLok EVO Ring Fixation

Shoulder Innovations Receives FDA Clearance for InSet Stemless Humeral Implant

Carbon22 Gains FDA 510(k) for Apollo Ankle Plates

L&K Biomed Granted FDA Clearance for Expandable Interbody

VySpine Granted FDA Clearance for LumiVy Lumbar Interbody Fusion

CoreLink Gains FDA Clearance for Fusation Cervical Anchors

GLEAMER Granted FDA Clearance for AI Fracture Detection

FDA Clearance for SurGenTec ION Spinal Fixation

Nvision Biomedical FDA Clearance for Trigon Wedges

Gramercy Extremity Orthopedics Gains FDA Clearance on Newest Plating Lines

Theradaptive Granted Breakthrough Device Designation

Bonalive Granules Gain Breakthrough Device Designation

Bone Solutions Gains FDA Clearance for Mg OSTEOREVIVE Spine Magnesium-Based ...

Kuros Biosciences’ MagnetOs Granules FDA-Cleared for Expanded Spinal Indications

AxioMed LLC Files PMA Module II For Viscoelastic Disc

VySpine Gains FDA Clearance for ClariVy Cervical IBF System

Innovasis Launches 3D-Printed Stand-Alone Titanium ALIF with HAnano Surface

Magnesium Development Company Gains Breakthrough Device Designation

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

Ortoma Gains Japan Approval for Surgical Planning System

AxioMed Files 1st PMA Module with Freedom Lumbar Disc