Cleared Special

Freedom? Total Knee System ? Titanium Tibial Base Plate

K251717 · Maxx Orthopedics, Inc. · Orthopedic

Jun 2025

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K251717 is an FDA 510(k) clearance for the Freedom? Total Knee System ? Titanium Tibial Base 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 June 26, 2025, 22 days after receiving the submission on June 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K251717 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2025
Decision Date	June 26, 2025
Days to Decision	22 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