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P.F.C. 98-0135

by Depuy (Ireland)

Ref 98-0135Model P.F.C. P.F.C. SIGMA Cemented Fixed Bearing Tibial Tray (Ti Alloy)

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

11 Sep 2029

CE MDR certificate

FDA recalls

None ongoing

16 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K241000

+2 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776531 Date15 Jul 2026IssuedStatusActive expires 11 Sep 2029
United StatesFDA 510(k) GUDID from GUDID NumberK241000 Date11 Jul 2024IssuedStatusActive
United StatesGUDID listing GUDID Number10603295251743 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776531 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    11 Sep 2029
    Reason
    Change approved

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
P.F.C.
Generic name
Uncoated knee tibia prosthesis, metallic
Device name
Cemented Fixed Bearing Tibial Tray (Ti Alloy)
Model / Ref / Catalog
98-0135, P.F.C. P.F.C. SIGMA Cemented Fixed Bearing Tibial Tray (Ti Alloy), 980135
Primary DI / UDI-DI
10603295251743
Basic UDI-DI
0603295a003148G
510(k) Number
FDA product code
JWH
EMDN code
P090903020104 Bicompartmental primary implant cemented fixed bearing tibial plates
GMDN term
Uncoated knee tibia prosthesis, metallic
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

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Properties

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

Other properties (19)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No