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Lps 1987-16-310

by Depuy (Ireland)

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233980 Date21 Mar 2024DecidedStatusActive
United StatesGUDID listing Number10603295078920 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Recalls

16 recalls · FDA

    • Terminated Z-3099-2011 FDA Unclassified (pre-2012) initiated 28 Jun 2011

    DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella, but the product enclosed in the package is a P.F.C. SIGMA 35mm 3 peg Oval Dome Patella.

  • 15 recalls, same reason

    • Terminated Z-1336-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1345-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1337-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1343-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1333-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1341-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1334-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1338-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1339-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1342-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1344-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1346-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1335-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1332-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1340-05 FDA Unclassified (pre-2012) initiated 26 May 2005

    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lps
Generic name
Knee femur stem prosthesis
Model / Ref / Catalog
1987-16-310, 198716310
Primary DI / UDI-DI
10603295078920
510(k) Number
FDA product code
JWH, JDI
GMDN term
Knee femur stem prosthesis
Device class
Class II
Regulation number
888.3560, 888.3350
GUDID distribution status
In Commercial Distribution

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Other devices from Depuy (Ireland)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No