510(k) Clearance

June 21, 2022

Altus Spine Granted FDA Clearance for Sochi OCT System

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.
June 16, 2022

Novarad Gains 510(k) for AR Surgical Navigation

Novarad Gains 510(k) for AR Surgical Navigation
VisAR, an augmented reality surgical navigation system, is cleared for precision-guided intraoperative spine surgery.
June 14, 2022

Xenco Medical Expands ASC Device Portfolio

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.
June 9, 2022

FX Gains 510(k) for Shoulder Replacement Platform

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.
May 31, 2022

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

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.
May 31, 2022

Embody Granted 510(k) Clearances for TAPESTRY RC

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.
May 31, 2022

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

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.
May 18, 2022

CTL Amedica Navigation Instrument System Gains FDA 510(k)

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.
April 28, 2022

ExsoMed Gains 510(k) for NanoPhix Cannulated Lag Screw

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.
April 25, 2022

CoNextions TR Tendon Repair Receives FDA Clearance

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....
April 12, 2022

SpineUp Gains FDA Clearance for Romero Cervical Cages

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.
March 16, 2022

Orthofix Gains FDA Clearance for TrueLok EVO Ring Fixation

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.
March 14, 2022

Carbon22 Gains FDA 510(k) for Apollo Ankle Plates

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.
March 8, 2022

CoreLink Gains FDA Clearance for Fusation Cervical Anchors

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.
February 16, 2022

Bonalive Granules Gain Breakthrough Device Designation

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.
December 2, 2021

CoreLink Launches CentraFix Midline Fixation System

CoreLink Launches CentraFix Midline Fixation System
The system features modular cobalt chrome tulip heads for intraoperative flexibility and increased visualization in smaller incisions.
November 8, 2021

FDA 510(k) for nView s1 Surgical Navigation

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.
September 22, 2021

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

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.
August 17, 2021

Globus Medical Announces FDA 510(k) Clearance for Excelsius3D

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.
August 11, 2021

Auctus Surgical: FDA Breakthrough Device Designation

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.
June 29, 2021

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

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.
June 22, 2021

CoreLink Gains FDA Clearance for F3D Corpectomy System

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.
June 16, 2021

OXOS Medical Gains FDA Clearance for Micro C in Pediatrics

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.
May 3, 2021

Next Science Gains FDA 510(k) for Antimicrobial Solution

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.
April 28, 2021

Pixee Medical Receives FDA Clearance for Knee+

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.
March 10, 2021

Cuptimize Gains 510(k) for Cup Placement Software

Cuptimize Gains 510(k) for Cup Placement Software
The proprietary software is designed to identify and treat spinopelvic motion abnormalities in total hip replacement.
February 24, 2021

FDA Clearance for G21 SpaceFlex Shoulder

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.
January 26, 2021

ChoiceSpine Gains Additional Clearance for Cervical Spacer

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.
January 25, 2021

OrthoSpin Gains FDA Clearance for G2 System

OrthoSpin Gains FDA Clearance for G2 System
This is the company's second generation robotic digitally-enabled external fixation system for orthopedic treatments.
December 8, 2020

Zebra Medical Gains FDA 510(k) for AI Technology

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.
November 10, 2020

icotec Gains FDA Clearance for VADER Pedicle System

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.
November 9, 2020

NuVasive Gains FDA Clearance for Thoracolumbar Interbodies

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.
September 29, 2020

Conformis Granted 510(k) Clearance for Cordera Hip

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,
September 2, 2020

CTL Amedica Gains FDA Clearance for MONDRIAN LIF Cage

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.
August 26, 2020

SurGenTec Gains FDA Clearance for OsteoFlo NanoPutty

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.
July 20, 2020

Orthofix Gains Regulatory Clearances for JuniOrtho Plate

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.
June 17, 2020

SIRAKOSS Receives FDA Clearance for Osteo3 ZP Putty

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.
June 11, 2020

Naviswiss Gains FDA Clearance for Miniature Hip Navigation

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.
May 27, 2020

Axis Spine Gains FDA Clearance for Axis-ALIF

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.
May 14, 2020

Back 2 Basics Gains FDA Clearance for eCarbon Spinal Rod

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.
May 13, 2020

Medacta Expands its Hip and Shoulder Portfolio

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.
May 7, 2020

Camber Spine Launches New Anterior Cervical Plates

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.
May 5, 2020

NuVasive Expands Advanced Materials Science Implant Portfolio

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.
April 28, 2020

Life Spine Gains FDA Clearance for Additions to ARx

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.
April 23, 2020

Nanovis Awarded FDA Clearance for Nano FortiFix Pedicle Screw

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.
March 31, 2020

Nexxt Spine Launches Nexxt Matrixx Corpectomy

Nexxt Spine Launches Nexxt Matrixx Corpectomy
Nexxt Spine received FDA 510(k) clearance of the Nexxt Matrixx® Corpectomy System, and commenced product launch.
January 6, 2020

Medacta Gains FDA Clearance for MyShoulder Placement Guides

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.
November 4, 2019

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.
October 23, 2019

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.
October 17, 2019

CarboFix Gains FDA Clearance for Carbon Fiber VBR

CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber Vertebral Body Replacements.
October 2, 2019

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.
September 27, 2019

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.
September 19, 2019

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.
September 5, 2019

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.
July 25, 2019

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.
July 25, 2019

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.
July 12, 2019

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.
May 13, 2019

Tenex Health Gains FDA Clearance for TX-Bone

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.
April 23, 2019

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.
April 18, 2019

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.
April 15, 2019

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.
April 3, 2019

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.
March 26, 2019

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.
March 19, 2019

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.
March 13, 2019

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.
February 27, 2019

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.
February 25, 2019

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.
February 19, 2019

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.
February 18, 2019

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.
January 14, 2019

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. 
January 2, 2019

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.
December 10, 2018

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.
November 27, 2018

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.
November 9, 2018

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.
November 2, 2018

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.
October 18, 2018

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. 
October 10, 2018

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. 
September 28, 2018

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.
September 27, 2018

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.
September 27, 2018

Alphatec Gains FDA Clearance for OsseoScrew

Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw. 
September 26, 2018

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.
September 21, 2018

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.
September 21, 2018

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.
September 18, 2018

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.
August 15, 2018

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. 
July 27, 2018

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.
July 27, 2018

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.
July 17, 2018

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.
July 9, 2018

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. 
June 21, 2018

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.
June 21, 2018

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.