Medical Device Network

DePuy bags FDA 510(K) clearance for robotic-assisted knee surgery device

The clearance for unicompartmental knee arthroplasty follows a previous clearance for the device in total knee arthroplasty.

Florida-based orthopaedics company DePuy Synthes has received 510(k) clearance from the US Food and Drug Administration (FDA) for the clinical application of its Velys robotic-assisted system for unicompartmental knee arthroplasty (UKA) procedures.

The Johnson & Johnson-owned company comes as one of a number of indications the robotic assistant is validated in, including total knee arthroplasty (TKA). The DePuy Synthes robotic assistant is designed for both medial and lateral procedures with the aim of enabling surgeons to carry out procedures without the need for a CT scan.

Otherwise known as a partial knee replacement, UKA is becoming a much more frequent procedure due to its ability to shorten recovery times for patients. Research published in the Journal of Orthopaedics and Traumatology found that the procedure can encourage bone preservation.

Additional research conducted by GlobalData found that the total number of partial knee reconstruction procedures carried out in North America totaled 36,994, with that figure estimated to rise to 78,457 procedures annually in 2030. At the same time, the market this year, with that figure expected to rise to $837m by the end of 2030.

Aldo Denti, company group chairman at DePuy Synthes, said: “We are committed to continually improving and expanding the capabilities and user experience of our Velys Enabling Technology portfolio.

“We are excited to add a robotic-assisted offering with our clinically proven implant for UKA, which we believe will address some of the key unmet needs in the partial knee replacement segment, including accuracy and simplicity that other systems on the market do not fully address.

“Data and analytics will continue to serve as the backbone of our platform, which reveals real-time, actionable insights for surgeons to empower patient-specific operative decisions with the goal of improving outcomes and delivering personalisation at scale."

It follows after DePuy Synthes saw its TriLeap lower extremity anatomic plating system, used by surgeons to stabilise bones during a bunionectomy, similarly granted clearance by the FDA.

Elsewhere in the field of knee replacement surgery, the US-based Exactech has launched its ExactechGPS, a software system designed to improve total knee replacement surgery. At the same time, Brixton Biosciences has raised $33m to further develop Neural Ice, its pain management platform designed for the treatment of osteoarthritis.