Ensemble CMC Implant : Ensemble Orthopedics gets FDA 510(k) clearance

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Ensemble Orthopedics has secured 510(k) clearance from the US Food and Drug Administration for its Ensemble CMC Implant for the treatment of patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint.

According to the Texas-based medical device company, the Ensemble CMC Implant has a saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant that helps in normal, pain-free motion. Combined with the advantages of minimal joint resection with an inherently stable design, the CMC joint implant is appropriate for higher demand patients, said Ensemble Orthopedics.

With minimal disruption to the joint capsule and preservation of crucial stabilizing soft tissues, the Ensemble CMC device is inserted to offer the potential for quicker rehabilitation.

The Ensemble CMC Implant is available in three sizes and is said to use a simple instrument set.

Thomas Trumble – Chief Medical Officer of Ensemble Orthopedics said: “In my experience with CMC implants, the unique design of the Ensemble CMC distributes loads across joint surfaces providing superior implant stability and resistance subluxation/dislocation throughout its range of motion.

“Because the Ensemble CMC interpositional implant is stemless, it can be inserted through a smaller incision with less disruption than what is required for other implants, thereby preserving all major stabilizing soft tissue structures of the thumb.”

The Ensemble CMC Implant is said to be built using On-X PyroCarbon (pyrocarbon), a proprietary type of pyrolytic carbon produced by On-X Life Technologies.

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