Cleared Special

Freedom Infinia? Total Knee System

K253314 · Maxx Orthopedics, Inc. · Orthopedic

Oct 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253314 is an FDA 510(k) clearance for the Freedom Infinia? Total Knee System, 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 October 29, 2025, 29 days after receiving the submission on September 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K253314 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	October 29, 2025
Days to Decision	29 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