www.fdanews.com/articles/200369-ensemble-orthopedics-osteoarthritis-treatment-gets-cleared-by-fda
Ensemble Orthopedics’ Osteoarthritis Treatment Gets Cleared by FDA
December 9, 2020
Ensemble Orthopedics has obtained FDA 510(k) clearance for its Ensemble carpometacarpal (CMC) joint device, an implant that helps treat early-stage osteoarthritis of the CMC joint.
The interpositional implant is inserted using a minimally invasive, simple surgical procedure, causing minimal disruption to the joint capsule and preserving stabilizing soft tissues to help with rehabilitation, the company said.
The CMC implant, which is made of a durable and biocompatible material, comes in three sizes and uses a simple instrument set.