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P.F.C. Sigma 1581-01-115

by Depuy (Ireland)

Ref 1581-01-115Model SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

11 Sep 2029

CE MDR certificate

FDA recalls

None ongoing

8 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 StatesGUDID listing GUDID Number10603295062332 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

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

8 recalls · FDA

    • Terminated Z-1077-2014 FDA Class II initiated 9 Dec 2013

    Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.

    • Terminated Z-1686-2009 FDA Unclassified (pre-2012) initiated 7 May 2009

    There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.

  • 6 recalls, same reason

    • Terminated Z-0403-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0407-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0402-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0404-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0405-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0406-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
P.F.C. Sigma
Generic Name
Tibial insert
Device Name
Fixed Bearing Tibial Insert
Model / Ref / Catalog
1581-01-115, SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert, 158101115
Primary DI / UDI-DI
10603295062332
Basic UDI-DI
0603295a003158J
510(k) Number
FDA Product Code
JWH
EMDN Code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN Term
Tibial insert
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
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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Category: Tibial insert

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Cleared under the same submission (K241000)

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Cleared under the same submission (K943462)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No