Cleared Traditional

LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY

K041085 · Depuy, Inc. · Orthopedic

Jul 2004

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K041085 is an FDA 510(k) clearance for the LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY, 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 22, 2004, 87 days after receiving the submission on April 26, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K041085 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2004
Decision Date	July 22, 2004
Days to Decision	87 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