Dive Brief:
- Zimmer Biomet received 510(k) clearance for a shoulder feature for its Rosa surgical robot, positioning it as the first company to market for robotic-assisted shoulder replacements.
- The Food and Drug Administration’s decision came earlier than expected, Evercore ISI analysts wrote in a research note. They had expected a mid-year clearance and launch.
- Competitor Stryker plans to launch a shoulder feature for its Mako robot at the end of the year, CEO Kevin Lobo said in an earnings call last month.
Dive Insight:
Zimmer plans a commercial launch for the Rosa shoulder in the second half of 2024, the company said in the Thursday announcement. It’s the company’s fourth robotics application, in addition to its knee and hip platforms.
Rosa shoulder is designed to allow surgeons to perform anatomic or reverse shoulder replacements. It’s also designed to help with precise glenoid and humeral placement, which can be critical for outcomes after surgery and the durability of the implant.
The system also integrates with Zimmer’s surgical planning system, which allows surgeons to visualize a surgery in advance and create patient-specific guides.
Evercore analysts posed questions about the training requirements, adoption curve for shoulder procedures, and whether the application could lead to share gains.
Zimmer CEO Ivan Tornos said in a recent earnings call that the company expects to place about 300 Rosa robots per year, with about a third of those installations in ambulatory surgery centers.
Stryker is also working on a shoulder application for its Mako robot, which it expects to release at the end of the year. It plans to start with reverse shoulder procedures, which make up two thirds of the shoulder market, and focus on bone preparation as a differentiating factor, RBC Capital Markets analyst Shagun Singh wrote in a research note.
Stryker has said that with Mako, it can reduce recovery time to six days instead of six weeks and make it easier to do complex procedures, added Singh.