Cleared Traditional

Freedom(R) - TiNbN Coated Knee

K200912 · Maxx Orthopedics, Inc. · Orthopedic

Nov 2020

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K200912 is an FDA 510(k) clearance for the Freedom(R) - TiNbN Coated Knee, 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 November 18, 2020, 226 days after receiving the submission on April 6, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K200912 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2020
Decision Date	November 18, 2020
Days to Decision	226 days
Submission Type	Traditional
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