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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K253171
Device Name Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
Applicant
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Applicant Contact Donald Guthner
Correspondent
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Correspondent Contact Donald Guthner
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
MEH   OQI  
Date Received09/26/2025
Decision Date 01/15/2026
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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