Cleared Special

Freedom Total Knee System (All-poly Tibial Plate)

K250382 · Maxx Orthopedics, Inc. · Orthopedic

Mar 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250382 is an FDA 510(k) clearance for the Freedom Total Knee System (All-poly Tibial Plate), a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on March 13, 2025, 30 days after receiving the submission on February 11, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K250382 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2025
Decision Date	March 13, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560