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FDA issues 510(k) clearance for Zimmer’s robotic system

Zimmer Biomet has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its ROSA Shoulder System, a robotic assistant for shoulder replacement surgery.

The ROSA Shoulder System expands the company’s ROSA Robotics portfolio, which already includes solutions for knee and hip replacement.

It strengthens the company’s shoulder implant portfolio, which includes the Identity Shoulder System.

This system joins ZBEdge Dynamic Intelligence, augmenting the firm’s advanced digital and robotic technologies.

The ROSA Shoulder system is designed to offer versatility to surgeons for performing total shoulder replacements using either anatomic or reverse techniques, aiming for precise implant placement and improved patient outcomes.

It is also capable of reproducing humeral head resection and facilitating instrument insertion without requiring a central pin in the glenoid during surgery.

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Furthermore, the system supports data-driven decision-making by leveraging patient-specific anatomical data.

Pre-operatively, it works with the Signature ONE Surgical Planning System 2.0 for 3D imaging, planning, and guide creation.

Intra-operatively, it provides real-time data to assist surgeons in glenoid and humeral positioning, potentially reducing patient complications.

Zimmer Biomet president and CEO Ivan Tornos said: “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.

“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.”

Planned to be commercially available in the US in the latter half of this year, the system will also be compatible with the mymobility Digital Care Management Platform.

Last year, Zimmer agreed to acquire privately held medical device company OSSIS.

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