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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K260582
Device Name ROSA® Shoulder System
Applicant
Orthosoft Inc. (d/b/a) Zimmer CAS
75 Queen St. Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Viviana Hernandez
Correspondent
Orthosoft Inc. (d/b/a) Zimmer CAS
75 Queen St. Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Viviana Hernandez
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received02/20/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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