Zimmer Biomet Receives FDA Clearance for ROSA® Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery
The ROSA® Shoulder System Becomes the First-to-Market Robotic Surgical Assistant for Shoulder Arthroplasty and the Fourth ROSA Robotics Application in Five Years
WARSAW, Ind.,
ROSA Shoulder strengthens
"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 Chief Executive Officer at
ROSA Shoulder is designed to give surgeons the flexibility to execute a total shoulder replacement using anatomic or reverse techniques and to enable precise placement for improved outcomes1. ROSA Shoulder is one of the only systems that can reproduce humeral head resectioning, and can ease insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures. Like all ROSA Robotics applications, ROSA Shoulder is designed to support data-informed physician decision-making based on a patient's unique anatomy. Pre-operatively, ROSA Shoulder integrates with the newly released Signature™ ONE Surgical Planning System 2.0, which uses a 3-D 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 placement1, with a goal to reduce complications for patients.2,3,4,5
"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," said
ROSA Shoulder will be commercially available in the
To learn more about ROSA Shoulder, visit zimmerbiomet.com/ROSAShoulder.
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This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "aims," "anticipates," "plans," "looking forward to," "estimates," "projects," "assumes," "guides," "targets," "forecasts," "continue," "seeks" or the negatives of such terms or other variations on such terms or comparable terminology. Forward-looking statements include, but are not limited to, statements concerning the Company's expectations, plans, intentions, strategies, prospects, business plans, product and service offerings, new product launches, potential clinical successes, and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. Some of these risks and uncertainties can be found in
References:
1 Data on File FER-JSB231211-01 Rev. A. Cadaveric studies not indicative of clinical performance.
2 Gregory TM, Sankey A, Augereau B, Vandenbussche E, Amis A, Emery R, Hansen U. Accuracy of glenoid component placement in total shoulder arthroplasty and its effect on clinical and radiological outcome in a retrospective, longitudinal, monocentric open study. PLoS One 8(10): e75791, 2013.
3 Chalmers PN, Boileau P, Romeo AA, Tashjian RZ. Revision Reverse Shoulder Arthroplasty. J Am Acad Orthop Surg. 2019 Jun 15;27(12):426-436. doi: 10.5435/JAAOS-D-17-00535. PMID: 31170096.
4 Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):555-62. doi: 10.1016/j.jse.2006.11.004. Epub 2007 May 16. PMID: 17509905.
5 Duethman NC, Aibinder WR, Nguyen NTV,
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