FDA clears ROSA Shoulder robotic surgery system from Zimmer Biomet

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The ROSA Shoulder System for robot-assisted surgery. | Source: Zimmer Biomet

Zimmer Biomet announced last week that it received FDA 510(k) clearance for its ROSA Shoulder System, which it claimed is the first surgical robot for shoulder replacement. It is also the fourth application for the Robotic Surgical Assistant, which includes the ROSA Knee System for total knee arthroplasty and the ROSA Hip System for total hip replacement.

“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,” said Ivan Tornos, president and CEO of Zimmer Biomet, in a 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.”

With more than 90 years of experience, Zimmer Biomet said it offers an integrated suite of digital and robotic technologies that use data, data analytics, and artificial intelligence. The Warsaw, Ind.-based company has operations in over 25 countries and sales in over 100 countries.

Zimmer Biomet adds to portfolio

Zimmer Biomet said ROSA Shoulder joins its shoulder-implant portfolio, which includes the Identity Shoulder System. The robot also joins the ZBEdge Dynamic Intelligence platform, which is intended to enhance the Zimmer Inc. unit‘s digital technologies, robotics, and implants. 

The company said it designed ROSA Shoulder to give surgeons flexibility and to enable precise placement for improved outcomes. It is one of the only systems that can reproduce humeral head resectioning, asserted Zimmer Biomet.

ROSA can also ease the insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures, it explained.

As with other ROSA applications, the shoulder system supports data for physician decision-making based on unique anatomies, said Zimmer Biomet. Pre-operatively, it integrates with the newly released Signature ONE surgical planning system. Signature ONE uses a 3D image-based approach to visualization, surgical planning, and patient-specific guide creation.

During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute, and validate personalized plans for glenoid and humeral placement. Zimmer Biomet said this is in pursuit of the goal of reducing complications for patients.

ROSA Shoulder will work with the mymobility Digital Care Management Platform, adding to the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder-replacement surgery.

ROSA gives Mayo Clinic data before and during surgeries

“One of the challenging aspects of performing a shoulder replacement is accurate glenoid and humeral placement, which is a critical factor for post-operative function and long-term implant survival,” stated John W. Sperling, M.D., MBA, and a professor of Orthopedic Surgery at Mayo Clinic.

“This innovative approach is designed to allow surgeons to virtually walk through a procedure before making any resections, and then receive live feedback and the ability to control glenoid ream depth and intra-operatively validate cut resections during the procedure,” he said.

Mayo Clinic has a financial interest in Zimmer Biomet’s technology and said it will use any revenue it receives to support its not-for-profit mission in patient care, education, and research. 

Zimmer Biomet said ROSA Shoulder will be commercially available in the U.S. in the second half of 2024.

Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice. 

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