Fact checked byGina Brockenbrough, MA

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February 24, 2024
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Zimmer Biomet receives FDA 510(k) clearance of robotic total shoulder replacement system

Fact checked byGina Brockenbrough, MA
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Key takeaways:

  • Zimmer Biomet received FDA clearance of its Rosa robotic-assisted total shoulder replacement system.
  • The system can be used with anatomic or reverse total shoulder replacement techniques.

Zimmer Biomet Holdings Inc. has announced FDA 510(k) clearance of its Rosa shoulder system, a robotic-assisted total shoulder replacement system, according to a press release.

The Rosa shoulder system is the latest addition to the Zimmer Biomet Rosa robotics portfolio, which includes the Rosa total knee replacement and Rosa total hip replacement systems. The Rosa shoulder system can be used for anatomic or reverse shoulder replacement, according to the release.

Generic FDA News infographic
Zimmer Biomet received FDA clearance of the Rosa robotic-assisted total shoulder replacement system.

“We are proud and excited to be the first company in the world to deliver a robotic surgical assistant for anatomic and reverse shoulder replacement surgery,” Ivan Tornos, president and CEO of Zimmer Biomet, said in the release. “Rosa shoulder represents a novel advancement intended to help surgeons leverage the power of robotics and data analytics to perform highly complex shoulder procedures with accuracy and efficiency,” Tornos said.

According to the release, the Rosa shoulder system will be commercially available in the U.S. in the second half of 2024.