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Ultima And Ultima Lx Cemented Femoral Stem

by Johnson & Johnson Professionals, Inc.

510(k) K972435

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972435 Date11 Sep 1997ClearedStatusActive

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-1906-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1912-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1908-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1911-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1909-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1907-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1910-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1914-2012 FDA Class II initiated 16 May 2012
    • Terminated Z-1913-2012 FDA Class II initiated 16 May 2012

    DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultima and Ultima LX Cemented Femoral Stem is a femoral component designed for use in total or partial hip arthroplasty. It is a semi-constrained metal/polymer prosthesis intended to be implanted using PMMA bone cement.

This device is used in conjunction with an acetabular component and a modular hip head. It has received FDA 510(k) clearance and is classified as a Class II medical device under product code JDI.

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