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Thursday, November 14, 2024

FDA clears ROSA Shoulder robotic surgical procedure system from Zimmer Biomet


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The ROSA Shoulder surgical robot system.

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

Zimmer Biomet introduced final week that it acquired FDA 510(okay) clearance for its ROSA Shoulder System, which it claimed is the primary surgical robotic for shoulder substitute. It is usually the fourth software for the Robotic Surgical Assistant, which incorporates the ROSA Knee System for whole knee arthroplasty and the ROSA Hip System for whole hip substitute.

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

With greater than 90 years of expertise, Zimmer Biomet stated it presents 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 stated ROSA Shoulder joins its shoulder-implant portfolio, which incorporates the Id 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 stated it designed ROSA Shoulder to offer surgeons flexibility and to allow exact placement for improved outcomes. It is among the solely programs 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 heart of the glenoid throughout procedures, it defined.

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

Throughout the surgical procedure, the platform supplies surgeons with real-time, intra-operative knowledge to assist them management, execute, and validate personalised plans for glenoid and humeral placement. Zimmer Biomet stated that is in pursuit of the objective of lowering issues 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 offers Mayo Clinic knowledge earlier than and through surgical procedures

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

“This revolutionary strategy is designed to permit surgeons to nearly stroll by means of a process earlier than making any resections, after which obtain stay suggestions and the flexibility to manage glenoid ream depth and intra-operatively validate lower resections in the course of the process,” he stated.

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

Zimmer Biomet stated ROSA Shoulder might be commercially out there within the U.S. within the second half of 2024.

Editor’s word: This text was syndicated from The Robotic Report sibling website MassDevice


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