Cleared Traditional

DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)

K061648 · DePuy Orthopaedics, Inc. · Orthopedic

Sep 2006

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K061648 is an FDA 510(k) clearance for the DEPUY GRADUATED COMPARTMENTAL KNEE (GCK), 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 September 11, 2006, 90 days after receiving the submission on June 13, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K061648 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2006
Decision Date	September 11, 2006
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.