Ensemble Orthopedics Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for its Ensemble CMC Implant, which was designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure.
Hand osteoarthritis is an extremely common condition that causes pain while limiting function. Current treatment modalities typically start with pharmacological and immobilization approaches for mild cases, progressing to surgical intervention with either joint resection or joint replacement in severe cases.
How The Ensemble CMC Implant WorksThe Ensemble CMC has a proprietary saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant that allows for normal, pain-free motion. This combines the advantages of minimal joint resection with an inherently stable design, thus making the implant suitable for higher demand patients. The Ensemble CMC device is inserted with minimal disruption to the joint capsule and preservation of critical stabilizing soft tissues offering the potential for faster rehabilitation. The Ensemble CMC is av...
