Cleared Special

DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS

K032151 · Depuy, Inc. · Orthopedic

Sep 2003

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K032151 is an FDA 510(k) clearance for the DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 26, 2003, 74 days after receiving the submission on July 14, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K032151 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2003
Decision Date	September 26, 2003
Days to Decision	74 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