Cleared Traditional

Freedom? Total Knee System - Porous Tibial Base Plate

K241597 · Maxx Orthopedics, Inc. · Orthopedic

Feb 2025

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K241597 is an FDA 510(k) clearance for the Freedom? Total Knee System - Porous Tibial Base Plate, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on February 13, 2025, 255 days after receiving the submission on June 3, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K241597 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2024
Decision Date	February 13, 2025
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565