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FDA clears ROSA Shoulder robotic surgical procedure system from Zimmer Biomet


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The ROSA Shoulder System for robot-assisted surgical procedure. | Supply: Zimmer Biomet

Zimmer Biomet introduced final week that it obtained FDA 510(ok) clearance for its ROSA Shoulder System, which it claimed is the primary surgical robotic for shoulder alternative. Additionally it is the fourth utility for the Robotic Surgical Assistant, which incorporates the ROSA Knee System for complete knee arthroplasty and the ROSA Hip System for complete hip alternative.

“We’re proud and excited to be the primary firm on the earth to ship a robotic surgical assistant for anatomic and reverse shoulder-replacement surgical procedure,” mentioned Ivan Tornos, president and CEO of Zimmer Biomet, in a launch. “ROSA Shoulder represents a novel development supposed to assist surgeons leverage the ability of robotics and knowledge analytics to carry out extremely complicated shoulder procedures with accuracy and effectivity.”

With greater than 90 years of expertise, Zimmer Biomet mentioned it gives an built-in suite of digital and robotic applied sciences that use knowledge, knowledge analytics, and synthetic intelligence. The Warsaw, Ind.-based firm has operations in over 25 international locations and gross sales in over 100 international locations.

Zimmer Biomet provides to portfolio

Zimmer Biomet mentioned ROSA Shoulder joins its shoulder-implant portfolio, which incorporates the Identification Shoulder System. The robotic additionally joins the ZBEdge Dynamic Intelligence platform, which is meant to boost the Zimmer Inc. unit‘s digital applied sciences, robotics, and implants. 

The corporate mentioned it designed ROSA Shoulder to provide surgeons flexibility and to allow exact placement for improved outcomes. It is likely one of the solely techniques that may reproduce humeral head resectioning, asserted Zimmer Biomet.

ROSA also can ease the insertion of devices into incisions by requiring no pin within the middle of the glenoid throughout procedures, it defined.

As with different ROSA purposes, the shoulder system helps knowledge for doctor decision-making based mostly on distinctive anatomies, mentioned Zimmer Biomet. Pre-operatively, it integrates with the newly launched Signature ONE surgical planning system. Signature ONE makes use of a 3D image-based method to visualization, surgical planning, and patient-specific information creation.

In the course of the surgical procedure, the platform gives surgeons with real-time, intra-operative knowledge to assist them management, execute, and validate personalised plans for glenoid and humeral placement. Zimmer Biomet mentioned that is in pursuit of the purpose of lowering problems for sufferers.

ROSA Shoulder will work with the mymobility Digital Care Administration Platform, including to the ZBEdge Dynamic Intelligence portfolio for sufferers present process shoulder-replacement surgical procedure.

 

ROSA provides Mayo Clinic knowledge earlier than and through surgical procedures

“One of many difficult elements of performing a shoulder alternative is correct glenoid and humeral placement, which is a vital issue for post-operative perform and long-term implant survival,” acknowledged John W. Sperling, M.D., MBA, and a professor of Orthopedic Surgical procedure at Mayo Clinic.

“This modern method is designed to permit surgeons to nearly stroll by way of a process earlier than making any resections, after which obtain dwell suggestions and the power to manage glenoid ream depth and intra-operatively validate minimize resections through the process,” he mentioned.

Mayo Clinic has a monetary curiosity in Zimmer Biomet’s know-how and mentioned it’s going to use any income it receives to assist its not-for-profit mission in affected person care, schooling, and analysis. 

Zimmer Biomet mentioned ROSA Shoulder shall be commercially obtainable within the U.S. within the second half of 2024.

Editor’s observe: This text was syndicated from The Robotic Report sibling web site MassDevice


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