Dive Brief:

• Johnson & Johnson received 510(k) clearance for its Velys surgical robot for use in partial knee replacement procedures, the company said Thursday
• J&J sees robotics as a way to overcome surgical challenges that it believes are limiting the use of partial knee replacement, despite the potential for the procedure to shorten recovery times. 
• The company, which received clearance for its robot in total knee procedures in 2021, has identified Velys as a product that can help it regain market share from rivals such as Stryker.

Dive Insight:

Stryker established a lead over J&J in the robotic space when it bought Mako Surgical in 2013. Zimmer Biomet entered the market when it received 510(k) clearance for its Rosa knee system in 2019. J&J took longer to get to market, receiving its first U.S. Velys clearance in 2021, and the company is now working to expand the use of its system.

The new Food and Drug Administration clearance covers the use of Velys in unicompartmental knee arthroplasty (UKA), the medical term for partial knee replacement. J&J said the procedure can support bone preservation and shorten recovery periods but is underused because of challenges such as smaller incisions and the lack of visibility.

“Achieving precise alignment and optimal implant placement is paramount for long-term success, and the ability to do so in a reproducible manner continues to be an unmet need in the UKA space,” John Redmond, an orthopedic surgeon, said in J&J’s press release. Redmond said Velys “will enable a more personalized procedure that helps drive reproducible outcomes” with better precision and accuracy.

The surgeon added that ambulatory surgery centers (ASCs) are a setting where Velys could be useful.

While other robots are already available for partial knee procedures, J&J believes the design of its device may be better suited to ASCs. J&J CEO Joaquin Duato discussed how Velys compares to robots such as Stryker’s Mako at Bernstein’s 40th Annual Strategic Decisions Conference in May.

“What we hear from orthopedic surgeons is that the Velys is a more compact robot than the competition and it occupies a smaller footprint,” Duato said. “So especially in the context of having crowded operating rooms, or even in the context of ASCs, having a smaller footprint, as Velys has, is an advantage. ... We have the opportunity to regain share and to deliver growth in our knee platform.”

J&J has yet to provide details of the commercial availability of Velys in the new indication. The company identified “strong performance in hips and knees” as a driver of the 4.3% year-over-year growth of its orthopedics unit in the first quarter earlier this year.