Cleared Special

FREEDOM METAL BACKED TIBIAL COMPONENT

K090411 · Maxx Orthopedics, Inc. · Orthopedic

Apr 2009

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K090411 is an FDA 510(k) clearance for the FREEDOM METAL BACKED TIBIAL 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 April 7, 2009, 48 days after receiving the submission on February 18, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K090411 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2009
Decision Date	April 07, 2009
Days to Decision	48 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