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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K253515
Device Name Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments
Applicant
Biomet Orthopedics, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Ainsley Carne
Correspondent
Biomet Orthopedics, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Ainsley Carne
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LPH  
Date Received11/07/2025
Decision Date 08/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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