Cleared Traditional

LPS

K033959 · Depuy, Inc. · Orthopedic

Jul 2004

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K033959 is an FDA 510(k) clearance for the LPS, 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 July 1, 2004, 192 days after receiving the submission on December 22, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K033959 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2003
Decision Date	July 01, 2004
Days to Decision	192 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