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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K261563
Device Name Freedom Total Knee System (E-Poly Tibial Liners)
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 Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received05/11/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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