Cleared Traditional

FREEDOM TOTAL KNEE SYSTEM

K082019 · Maxx Orthopedics, Inc. · Orthopedic

Feb 2009

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K082019 is an FDA 510(k) clearance for the FREEDOM 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. (North Attleboro, US). The FDA issued a Cleared decision on February 6, 2009, 205 days after receiving the submission on July 16, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K082019 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2008
Decision Date	February 06, 2009
Days to Decision	205 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