Zimmer Biomet (NYSE:ZBH) expects to launch a robot-assisted surgery platform for total knee procedures during the 2nd half of 2018, the company said this week at the annual conference of the American Academy of Orthopedic Surgeons in San Diego.
A prototype of the device, on display at the AOSS conference, is based on the Rosa technology Zimmer Biomet acquired when it put up $132 million for Medtech in July 2016. Montpellier, France-based Medtech developed the Rosa Brain and Rosa Spine robot-assisted surgery platforms; the Rosa Spine device won 510(k) clearance from the FDA early last year. Both Rosa systems have CE Mark approval in the European Union.
Zimmer Biomet is hoping to land 510(k) approval from the FDA for a Rosa device for total knee procedures by the 2nd half of 2018, according to Leerink Partners analyst Richard Newitter. The company will also pursue 510(k) clearance for partial knee and hip indications, Newitter wrote today in a note to investors.
A soft launch for the total knee – Zimmer Biomet calls it a “clinical evaluation period” – coincident with the 1st FDA clearance is slated to be followed by a full commercial launch in 2019, he wrote.
“Mgmt was tight-lipped about exactly how the robot would work (i.e., unclear whether end-effector will be a bone cutting tool). But it sounded to us as if the focus may be more on tissue balancing vs. just going after accurate bone cuts,” Newitter wrote. “The company also sounded as if it might be open to a lower capital acquisition cost model (possibly in exchange for volume discounts).”