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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K252777
Device Name Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
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 Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received09/02/2025
Decision Date 10/31/2025
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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