J&J cleared to expand use of Velys robotic system in U.S.

hapabapa The U.S. FDA has issued 510(k) clearance for Johnson & Johnson's ( NYSE: JNJ ) Velys robotic-assisted solution, expanding its use for unicompartmental knee arthroplasty (UKA), also known as partial knee replacement, J&J's DePuy Synthes unit announced Friday.

DePuy, JNJ's orthopedics unit, added that the system is designed to allow implant placement without a CT scan. Velys' application in UKA will be compatible with J&J's ( JNJ ) SIGMA HP partial knee implant. The approval builds on Velys' current application in total knee arthroplasty, as approved across 20 markets.

The company said that the approval will help it address an unmet medical need as patients, providers, and payers are unable to benefit from UKA's cost and clinical advantages due to issues such as lack of access and visibility. More on Johnson & Johnson Johnson & Johnson: Market Will Regret The Overreaction Johnson & Johnson (JNJ) Bernstein's 40th Annual Strategic Decisions Conference - (Transcript) Johnson & Johnson: Vital Signs Decent, A Compelling Value Case J&J seeks to expand HIV med Prezcobix indication to children as young as six Oregon jury awards talc plaintiff $260M in verdict against Johnson & Johnson.