Regulatory

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 27, 2022

Empirical Spine Submits PMA Module II for Limiflex

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.
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 30, 2022

FDA Approves CartiHeal’s Agili-C Implant

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.
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.
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.