Ensemble Orthopedics Gains FDA Clearance For PyroCarbon CMC Interpositional Implant

By Julie A. Vetalice

Ensemble Orthopedics Gains FDA Clearance For PyroCarbon CMC Interpositional Implant

Ensemble Orthopedics received FDA 510(k) clearance to market the Ensemble CMC Implant to treat early-stage osteoarthritis of the carpometacarpal (CMC) joint in a minimally invasive procedure.

Ensemble CMC is based on On-X® PyroCarbon, a proprietary form of pyrolytic carbon produced by On-X Life Technologies. The high strength, low modulus material has shown to offer superior wear resistance when bearing against bone than metal or ceramic.

Ensemble CMC has a proprietary saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant. This combines minimal joint resection with a stable design suitable for higher demand patients.

Ensemble CMC is inserted with minimal disruption to the joint capsule and preservation of critical stabilizing soft tissues offering the potential for faster rehabilitation.

Product Labels: Finger/Hand/Wrist Replacement

Tags: 510(k) Clearance, Regulatory