Cleared Traditional

K070849 - DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
(FDA 510(k) Clearance)

K070849 · DePuy Orthopaedics, Inc. · Orthopedic

Jun 2007

Decision

90d

Days

Class 2

Risk

K070849 is an FDA 510(k) clearance for the DEPUY GCK FEMORAL AND TIBIAL COMPONENTS. This device is classified as a Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code NPJ).

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 26, 2007, 90 days after receiving the submission on March 28, 2007.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560. The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement..

Submission Details

510(k) Number	K070849 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2007
Decision Date	June 26, 2007
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560
Definition	The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement.