Regulatory

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.
October 7, 2021

Syntellix Granted Approval to Market Devices in India

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.
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.
July 29, 2021

Medacta Expands Hip Revision Portfolio

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.
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 28, 2021

ZygoFix Obtains CE Mark for zLOCK Spinal Fusion

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.
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 21, 2021

Prosidyan Gains CE Mark for FIBERGRAFT Bone Grafts

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.
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.
April 14, 2021

Hensler Surgical Obtains CE Mark Approval for Hensler Bone Press

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.
March 16, 2021

FDA Issues Safety Communication on STAR Ankle

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.
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.
March 2, 2021

Conformis Gains Clearance for iTotal PS Knee in Australia

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.
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.
October 15, 2020

DJO Global Emerges as Buyer for Stryker Divestitures

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.
October 12, 2020

CartiHeal Agili-C Granted Breakthrough Device Designation

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.
October 6, 2020

Graftys Gains CE Recertification of Bone Void Fillers

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.
October 5, 2020

MagnetOs Bone Grafts Approved in Australia

MagnetOs Bone Grafts Approved in Australia
MagnetOs Granules and MagnetOs Putty received TGA approval in Australia. Initial market launch is scheduled for late 1Q21.
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 15, 2020

Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

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.
September 14, 2020

NovoPedics’ MeniscoFix Granted Breakthrough Device Designation

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.
September 10, 2020

IZI Medical Gains CE Mark for Kiva VCF Treatment

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.
September 8, 2020

Smith+Nephew Launching REDAPT Revision Hip in China

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.
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 22, 2020

Cerapedics Gains FDA Approval of IDE Supplement

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.
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.
July 15, 2020

7D Surgical Gains CE Mark for Spinal Image Guidance System

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.
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 16, 2020

Smith+Nephew’s REGENETEN Implant Gains CE Mark

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.
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.
June 9, 2020

Implanet Granted CE Mark Renewal for Madison Knee

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.
June 8, 2020

Rejoint YourKnee Gains Additional CE Mark Approval

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.
June 3, 2020

Medacta Gains CE Mark for Shoulder Implants

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.
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 27, 2020

Medacta Shares Sports Medicine Product Milestones

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.
May 21, 2020

Curexo Gains CE Mark Approval for CUVIS-spine Robot

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.
May 15, 2020

Foresee-X Smart Surgical Glasses Gain CE Mark Approval

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.
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.
April 23, 2020

Biocomposites Granted CE Mark for STIMULAN

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.
April 9, 2020

Signus Medizintechnik Gains CE Mark for BIG ST ALIF Cage

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.
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.
March 26, 2020

AgNovos Receives Breakthrough Device Designation for Spine Device

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.
February 27, 2020

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

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.
January 16, 2020

Rejoint YourKnee Receives CE Mark Approval

Rejoint YourKnee Receives CE Mark Approval
REJOINT received CE Mark approval for the YourKnee™ patient-specific 3D-printed total knee replacement.
January 6, 2020

Episurf Medical Patent and Regulatory Updates

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.
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 18, 2019

Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR

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.
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 14, 2019

Spineway Mont Blanc MIS Approved in Japan

Spineway obtained regulatory approval in Japan for its Mont Blanc minimally invasive surgical devices.
October 8, 2019

U.K.’s NICE Maintains Recommendation for Bioventus’ EXOGEN

U.K.’s NICE Maintains Recommendation for Bioventus’ EXOGEN
The National Institute for Health and Clinical Excellence in the U.K. updated its guidance regarding use of Bioventus' EXOGEN® Ultrasound Bone Healing System to treat long bone fractures. 
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.
August 28, 2019

ApiFix Gains FDA Approval for MID-C Scoliosis Treatment

ApiFix received Humanitarian Device Exemption approval to market the MID-C Minimally Invasive Deformity Correction system to treat adolescent idiopathic scoliosis.
August 26, 2019

DiscGenics Receives FDA Fast Track Designation for Cell Therapy

DiscGenics was granted Fast Track designation from FDA for its investigational cell therapy, IDCT, under evaluation in clinical trials in the U.S. and Japan to treat pain and disability from degenerative disc disease.
August 16, 2019

Zimmer Biomet Gains FDA Approval for Tether Scoliosis Treatment

Zimmer Biomet received FDA approval for The Tether, a vertebral body tethering system that offers an alternative to fusion in the treatment of pediatric scoliosis.
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

Orthofix M6-C Disc in First U.S. Patients Following PMA

Orthofix Medical announced first commercial U.S. implants of the M6-C cervical disc following FDA Premarket Approval of the device.
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 16, 2019

Brainlab Recalls Spine & Trauma 3D Navigation Software

Brainlab Recalls Spine & Trauma 3D Navigation Software
Brainlab recalled Spine & Trauma 3D Navigation 1.0 software due to the potential for incorrect information to display during surgery, preventing acccurate navigation of surgical tools inside the patient. FDA has identified this as a Class I recall.
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 14, 2019

AxioMed Gains CE Mark Approval

AxioMed was issued approval under the CE Mark for their viscoelastic cervical disc replacement.
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 28, 2019

Vertos mild® Procedure Gains CE Mark

Vertos Medical received CE Mark approval for the mild® device kit for the treatment of lumbar spinal stenosis.
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 31, 2019

SIRAKOSS Osteo3 Gains CE Mark

SIRAKOSS received approval under the CE Mark for Osteo3 nanosynthetic bone graft substitute.
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 3, 2019

JointPoint Gains Clearance for Digital Navigation in Canada

JointPoint obtained Health Canada licenses for ELITE and PRO surgical navigation systems, allowing for immediate deployment of these products in the region.
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 17, 2018

Episurf Medical Gains FDA Approval for IDE Study

Episurf Medical received FDA approval for its IDE application to commence a clinical study of the Episealer® knee device.
December 11, 2018

DiscGenics Entering Clinical Trial in Japan for Disc Cell Therapy

DiscGenics received approval in Japan to advance into clinical studies of IDCT allogeneic injectible disc cell therapy for the treatment of lumbar degenerative disc disease.
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 19, 2018

SIG Medical Gains FDA Clearance for AdvantageRib Anterior System

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