The interpositional implant is designed to help treat patients with early-stage osteoarthritis of the carpometacarpal joint

FDA device

The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Medical devices maker Ensemble Orthopedics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Ensemble carpometacarpal (CMC) interpositional implant.

The interpositional implant has been developed for the treatment of patients with early-stage osteoarthritis of the CMC joint using a minimally invasive and simple surgical procedure.

Ensemble CMC features a saddle shape, which replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant that facilitates normal and pain-free motion.

The device is said to allow insertion with minimal disruption to the joint capsule. It also helps in the preservation of critical stabilising soft tissues for fast rehabilitation.

Ensemble CMC implant is available in three sizes

The company is offering Ensemble CMC interpositional implant in three sizes and uses a simple instrument set.

The Ensemble CMC implant has been produced using On-X  PyroCarbon (pyrocarbon), an advanced form of pyrolytic carbon produced by On-X Life Technologies.

Pyrocarbon is high strength and low modulus material demonstrated to deliver better wear resistance when bearing against bone than either metal or ceramic.

Ensemble Orthopedics chief medical officer Dr Thomas Trumble 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.”

In November this year, THINK Surgical secured FDA approval for its second-generation TSolution One total knee application system.

Based in Austin of Texas, Ensemble Orthopedics is involved in the development of minimally invasive and minimally disruptive interpositional surgical solutions for the extremity arthroplasty market.