Cleared Traditional

FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT

K091280 · Maxx Orthopedics, Inc. · Orthopedic

Sep 2009

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K091280 is an FDA 510(k) clearance for the FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT, 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 September 25, 2009, 147 days after receiving the submission on May 1, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K091280 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2009
Decision Date	September 25, 2009
Days to Decision	147 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