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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 K253144
Device Name Freedom® Total Knee System – Titan PCK Components
Applicant
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Applicant Contact Corey Perine
Correspondent
Meril Healthcare Pvt. , Ltd.
H1 - H3, Meril Park, Survey No 135/2/B & 174/2
Muktanand Marg, Chala
Vapi,  IN 396191
Correspondent Contact Bittu Jha
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/25/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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