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P.F.C. Sigma 96-2732

by Depuy (Ireland)

Ref 96-2732Model 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

29 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776531 Date15 Jul 2026IssuedStatusActive expires 11 Sep 2029
United StatesGUDID listing GUDID Number10603295244080 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

29 recalls · FDA

    • Terminated Z-2949-2018 FDA Class II initiated 18 Jul 2018

    This unit may be missing the screw/collet Assembly

  • 27 recalls, same reason

    • Terminated Z-0423-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K963117
    • Terminated Z-0385-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0418-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0424-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K963117
    • Terminated Z-0426-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K963117
    • Terminated Z-0427-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K963117
    • Terminated Z-0401-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0388-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0399-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0395-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0397-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0387-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0420-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0398-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0419-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0425-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K963117
    • Terminated Z-0393-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0389-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0396-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0390-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0392-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0386-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0400-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0391-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0421-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0422-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0394-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010

    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.

    • Terminated Z-1369-04 FDA Unclassified (pre-2012) initiated 22 Dec 2003

    The collar was incorrectly etched for the R (right) and L (Left) orientation

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
96-2732, SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert, 962732
Primary DI / UDI-DI
10603295244080
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

Related devices

Category: Tibial insert

Cleared under the same submission (K241000)

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Cleared under the same submission (K950010)

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Cleared under the same submission (K952830)

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Cleared under the same submission (K963117)

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Cleared under the same submission (K971189)

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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