Cleared Traditional

FREEDOM(R) STEMMED TIBIAL COMPONENTS

K111785 · Maxx Orthopedics, Inc. · Orthopedic

Jun 2012

Decision

371d

Days

Class 2

Risk

About This 510(k) Submission

K111785 is an FDA 510(k) clearance for the FREEDOM(R) STEMMED TIBIAL COMPONENTS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Maxx Orthopedics, Inc. (Plymouth Meeting, US). The FDA issued a Cleared decision on June 29, 2012, 371 days after receiving the submission on June 24, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K111785 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2011
Decision Date	June 29, 2012
Days to Decision	371 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