CE Mark

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 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.
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.
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.
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.
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.
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 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 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

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.
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.
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.
March 14, 2019

AxioMed Gains CE Mark Approval

AxioMed was issued approval under the CE Mark for their viscoelastic cervical disc replacement.
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 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.
January 31, 2019

SIRAKOSS Osteo3 Gains CE Mark

SIRAKOSS received approval under the CE Mark for Osteo3 nanosynthetic bone graft substitute.
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.
December 20, 2017

K2M Receives CE Mark for CAPRI Cervical 3D Expandable Cage

K2M received approval under the CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage, and announced completion of its first surgical case.
October 19, 2017

Implanet Gains CE Mark Approval for JAZZ Passer

Implanet received approval under the CE Mark to market the JAZZ® Passer, used in posterior fixation procedures.
October 3, 2017

OrthAlign Gains CE Mark Approval for DAA HipAlign and UniAlign

OrthAlign received CE Mark Approval to market the DAA HipAlign® Direct Anterior Approach Total Hip system and UniAlign® Unicompartmental Knee Arthroplasty.
August 28, 2017

Regentis Biomaterials Receives CE Mark Approval for GelrinC Implant

Regentis Biomaterials received CE Mark approval for a GelrinC biodegradable implant based on denatured human fibrinogen for the treatment of articular knee cartilage defects.
January 6, 2017

Globus Medical Receives CE Mark for Excelsius GPS

Globus Medical received CE Mark approval for the Excelsius GPS™ robotic trajectory guidance and navigation system. 
December 19, 2016

Anika Gains CE Mark Approval for ORTHOVISC-T

Anika Therapeutics received CE Mark approval for ORTHOVISC®-T injection indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
December 16, 2016

Safe Orthopaedics Receives CE Mark for Oak Pedicle Screw

Safe Orthopaedics received approval under the CE Mark for a next-generation Oak pedicle screw for the treatment of thoracic vertebral fractures.
October 19, 2016

CollPlant VergenixSTR Receives CE Mark for Tendinopathy

CollPlant received CE Mark approval for Vergenix™STR soft tissue repair matrix for the treatment of tendinopathy. EU launch is anticipated in coming months.
April 5, 2016

Implanet Receives FDA Clearance and CE Mark for New Jazz Lock Implant

Implanet received FDA 510(k) clearance and CE Mark approval for Jazz Lock®, a band-shaped implant to treat degenerative spinal disorders, including cervical. Commercial launch is underway.
March 3, 2016

Xtant Medical Receives CE Mark for Aranax and Irix-A

Xtant Medical received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.
January 15, 2016

Episurf Medical Receives CE Mark for Epioscopy Damage Assessment Tool

Episurf Medical received CE Mark approval for the Epioscopy™ Damage Assessment Tool, designed to support 3D visualization of knee segments, visual marking of lesions and a written assessment of structural deviations on the tibia, patella, meniscus and ACL.