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Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves

by Depuy Orthopaedics, Inc. 510(k)

Active United States

510(k) K063633

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063633 Date2 Mar 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1103-2021 FDA Class II initiated 8 Jan 2021

    The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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