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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K261609
Device Name Freedom Partial Knee System
Applicant
Maxx Orthopedics, Inc.
2460 General Armistead Ave. #100
Norristown,  PA  19403
Applicant Contact Asawari Hare
Correspondent
Maxx Orthopedics, Inc.
2460 General Armistead Ave. #100
Norristown,  PA  19403
Correspondent Contact Asawari Hare
Regulation Number888.3520
Classification Product Code
HSX  
Date Received05/14/2026
Decision Date 08/04/2026
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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