510(k) Clearance

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.
April 30, 2018

Medtronic Gains FDA Approval for INFUSE with Additional PEEK Implants

Medtronic gained FDA approval for use of Infuse bone graft with additional PEEK-based implants in oblique lateral and anterior lumbar interbody fusion procedures at one level.
April 5, 2018

CTL Gains FDA Approval for Seurat Pedicle Screw

CTL Medical gained FDA 510(k) clearance to market the SEURAT Universal Pedicle Screw. The product is slated for 2H18 launch.
March 7, 2018

Orthofix Gains FDA and CE Mark Approvals for PhysioStim

Orthofix gained FDA premarket and CE Mark approval for next-gen PhysioStim bone growth stimulators, used as a nonsurgical treatment for nonunion fracture in the extremities.
March 7, 2018

Globus Medical Unveils FDA-Cleared Trauma Products

Globus Medical debuted its FDA-510(k)-cleared trauma products, comprising fracture plates, compression and cannulated screws, intramedullary nails and external fixation. 
February 6, 2018

Orthofix Gains FDA Clearance for FORZA XP Expandable Spacer

Orthofix received FDA 510(k) clearance to market the FORZA® XP Expandable Spacer for posterior and transforaminal lumbar interbody fusion.
January 24, 2018

Centric Medical Gains FDA Clearance of the Foot/Ankle Plate

Centric Medical received FDA 510(k) clearance for a new foot and ankle plating system for calcaneal slide osteotomy and metatarsal phalangeal, lapidus and midfoot fusion.
January 11, 2018

ReBOSSIS Bone Scaffold Gains FDA Clearance in Spine

ORTHOReBIRTH USA received FDA 510(k) clearance to market ReBOSSIS® biosynthetic bone scaffold for use in posterolateral spine procedures.
January 4, 2018

NuVasive Update on COALESCE, COHERE Interbody Fusion Devices

NuVasive launched COALESCE for Thoracolumbar Interbody Fusion, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion device with expanded indications.
November 27, 2017

Medicrea Gains FDA Clearance for 3D-Printed Ti Interbody

Medicrea received FDA 510(k) clearance to market IB3D™ 3D-printed interbody devices, and introduced its AdapTEK™ in-house additive manufacturing technology.
November 14, 2017

MedShape Receives FDA Clearance for DynaNail XL

MedShape received FDA 510(k) clearance to market the DynaNail® XL tibiotalocalcaneal fusion system.
November 9, 2017

DT MedTech Receives FDA Clearance for Hintermann Total Ankle

DT MedTech received FDA 510(k) clearance to market the Hintermann Series H2™ Total Ankle, a semi-constrained, cemented prosthesis for primary or revision surgery.
November 1, 2017

intellijoint HIP Cleared for Revision Arthroplasty

Intellijoint Surgical received FDA 510(k) clearance to market intellijoint HIP® navigation for revision procedures.
October 26, 2017

Medacta Receives FDA Clearance for Anatomic and Reverse Shoulders

Medacta received FDA 510(k) clearance to market Anatomic and Reverse Shoulder components for its modular Medacta Shoulder system. U.S. launch will occur in 1Q18.
October 16, 2017

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

NuVasive received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 20° cage, use with allogeneic bone graft and use in additional levels of the spine.
October 4, 2017

Nexxt Spine Gains FDA Clearance for NEXXT MATRIXX Devices

Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices. 
September 29, 2017

K2M Receives FDA Clearance for YUKON OCT System

K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine. 
September 27, 2017

HD LifeSciences Launches NanoHive Lumbar Interbodies

HD LifeSciences received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.
September 12, 2017

Implanet Gains FDA Clearance for JAZZ Passer

IMPLANET received FDA 510(k) clearance to market JAZZ™ Passer, a system of spinal instruments and braided band technology.
August 16, 2017

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

Strategic orthopaedic-related 510(k)s issued in July 2017 include: EIT Cellular Titanium Cages (EIT Emerging Implant Technologies), Lumbar Interbody System (HD LifeSciences), Gemini-C Hybrid Cervical Interbody System (Osseus Fusion Systems), LumFuse-TP (Precifit Medical), Anchorman Tibial Ligament Fixation (Summit Medical)
August 15, 2017

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

Camber Spine Technologies received FDA 510(k) clearance and commenced U.S. launch of the SPIRA™ Open Matrix ALIF device, manufactured with additive techniques. 
July 21, 2017

Trauma and Spine Markets Gain New FDA Clearances

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies entering the U.S. market.
July 17, 2017

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

Strategic orthopaedic-related 510(k)s issued in June 2017 include: Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS); Tranquil Interbody System (Nexus Spine); PHA S1 Spinal System (Phamedica); Total Hip Arthroplasty Device (Responsive Orthopedics/Medtronic); Interbody Fusion System (Spinal Analytics & Geometrical Implant); Channel Cervical Interbody System (Summit Spine); Coalesce Lumbar Interbody Fusion System (Vertera Spine)
July 11, 2017

FDA 510(k) Clearance for Stryker RF Generator

Stryker received FDA 510(k) clearance for the MultiGen 2 RF Generator for radiofrequency ablation to treat facet joint pain. 
June 20, 2017

Strategic orthopaedic-related 510(k)s issued in May 2017

Strategic orthopaedic-related 510(k)s issued in May 2017 include: Locking Plate System (Beijing KeYi Medical Device), Collagen Meniscus Implant XL (Ivy Sports Medicine), Kirschner Wires (Precifit Medical), SICAGE System (Sicage), MALUC Total Hip Arthroplasty System (SurgTech)
June 19, 2017

Medicrea Receives FDA Clearance for UNiD HUB Digital Portal

Medicrea received FDA 510(k) clearance for UNiD™ HUB, a data-driven digital portal that employs Adaptive Spine Intelligence for surgical planning.
June 13, 2017

SI-BONE Receives FDA Clearance for iFuse-3D

SI-BONE received FDA 510(k) clearance and commenced full U.S. launch of the iFuse-3D™ Implant.
May 18, 2017

Globus Medical to File Revised 510(k) for ExcelsiusGPS

Globus Medical plans to resubmit its 510(k) for the ExcelsiusGPS™ system to FDA, and noted that its clearance is now expected after 2Q17.
May 17, 2017

Strategic orthopaedic-related 510(k)s issued in April 2017

Strategic orthopaedic-related 510(k)s issued in April 2017 include: ExactechGPS Total Shoulder Application (Exactech filing as Blue Ortho); Locking Bone Plates and Screws Osteosynthesis Plating System, DHS/Dynamic Condylar Plate (Greens Surgicals); AX Standalone ALIF System (Innovasis); Mazor X (Mazor Robotics); PRECICE UNYTE CoCr System (NuVasive Specialized Orthopedics); NovoGro Putty (OsteoNovus); Balanced Plating System (Pantheon Medical); Yellowstone Lumbar Interbody Fusion System (Summit Spine); XO1 Knee Balancing System (XpandOrtho)
April 12, 2017

FDA Clearance for Mazor X Align Software

Mazor Robotics received FDA clearance to market Mazor X Align™ software for use in spinal deformity correction planning. Initial launch will occur in mid-2Q17.
April 12, 2017

FDA Clearance for UOC’s E-XPE Knee Insert

United Orthopedic received FDA 510(k) clearance to market the E-XPE™ polyethylene knee insert.
April 10, 2017

Strategic orthopaedic-related 510(k)s issued in March 2017

Strategic orthopaedic-related 510(k)s issued in March 2017 include: Joinix Cannular System (Aju Pharm), Unicompartmental Knee (Bodycad), Microfet 2 Dynamometer (Hoggan Scientific), Flex-Thread Clavicle Pin (Intrafuse), Evolution Revision Tibial System (MicroPort Orthopedics)
March 29, 2017

Providence Medical’s Recent FDA 510(k) Clearances

Providence Medical Technology received FDA 510(k) clearance for ALLY™ Facet Screws and for standalone use of the CAVUX™ Cervical Cage-L system.
March 15, 2017

Expanded FDA 510(k) for First Ray Stealth Staple

First Ray received FDA 510(k) clearance for additional sizes and materials in the Stealth Staple™ line.