FDA De Novo Classification Grant for Zimmer Biomet Persona IQ Knee

The Persona IQ Knee combines Zimmer Biomet's Persona Knee with Canary Medical's canturio™ te Tibial Extension sensor technology.

Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

The InSet Platform is designed to simplify shoulder replacement technology to improve outcomes for patients.

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.

Onkos Surgical Gains FDA 510(k) Clearance for BioGrip Modular Porous Collars

The new offering, part of the ELEOS Limb Salvage System, is designed to support bone ingrowth in musculoskeletal oncology and complex orthopaedic limb salvage cases.

FDA Clearance for Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot

THINK Surgical and Ortho Development gained FDA clearance for use of the Balanced Knee System and BKS TriMax Implants with the TSolution One Total Knee Application Active Robot.

Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

Identity Imprint is designed to match patients' anatomy while offering efficiency, cost savings, intraoperative flexibility and faster delivery.

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.

Conformis Hits Regulatory Milestone in Agreement with Stryker

With FDA clearance for patient-specific instrumentation, Conformis achieved its 3rd milestone and will receive $11 million from Stryker.

Implanet Gains Regulatory Clearance for MADISON Total Knee in Australia

This approval is part of the distribution agreement with KICo to market MADISON in the U.S. and Australia.

Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder System

Catalyst can now address stemless anatomic and reverse TSA, the two fastest growing segments of the shoulder replacement market.

Regulatory

Articles

FDA De Novo Classification Grant for Zimmer Biomet Persona IQ ...

FDA De Novo Classification Grant for Zimmer Biomet Persona IQ Knee

Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

Medacta Expands Hip Revision Portfolio

Medacta Expands Hip Revision Portfolio

Onkos Surgical Gains FDA 510(k) Clearance for BioGrip Modular Porous ...

Onkos Surgical Gains FDA 510(k) Clearance for BioGrip Modular Porous Collars

FDA Clearance for Balanced Knee System and BKS TriMax Implants ...

FDA Clearance for Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot

Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

Next Science Gains FDA 510(k) for Antimicrobial Solution

Next Science Gains FDA 510(k) for Antimicrobial Solution

Conformis Hits Regulatory Milestone in Agreement with Stryker

Conformis Hits Regulatory Milestone in Agreement with Stryker

Implanet Gains Regulatory Clearance for MADISON Total Knee in Australia

Implanet Gains Regulatory Clearance for MADISON Total Knee in Australia

Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder ...

Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder System

Regulatory Guidance

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