Skip to content

P.F.C. Sigma 1581-21-008

by Depuy (Ireland)

Part of a family of 371 devices: see the family page

Ref 1581-21-008Model SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert

P.F.C. Sigma 1581-21-008 (158121008) is a device classified as Class III in the EU and Class II in the US made by Depuy (Ireland), registered in EUDAMED on 23 Dec 2025 (Basic UDI-DI 0603295a003158J) with CE/MDR certificate MDR 776531 valid until 11 Sep 2029, cleared under FDA 510(k) K241000 on 11 Jul 2024 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295063926), active as of 25 Oct 2026. 49 FDA recalls are linked to it.

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

51 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K241000

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 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 Number10603295063926 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0603295a003158J registered 23 Dec 2025 Active· +1 more in the status table
  • FDA 510(k) K241000 decided 11 Jul 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10603295063926 listed 24 Sep 2015 Listed

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

51 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-0412-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0417-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0416-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0414-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0413-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0420-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0422-2014 FDA Class II initiated 18 Nov 2013 on shared 510(k) K033272
    • Terminated Z-0421-2014 FDA Class II initiated 18 Nov 2013 on shared 510(k) K033272
    • Terminated Z-0419-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0415-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0423-2014 FDA Class II initiated 18 Nov 2013
    • Terminated Z-0418-2014 FDA Class II initiated 18 Nov 2013

    DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

  • 39 recalls, same reason

    • Terminated Z-1163-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1167-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1179-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1189-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1156-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1177-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1168-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1188-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1155-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1191-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1170-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1176-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1165-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1187-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1181-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1180-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1164-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1174-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1157-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1154-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1186-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1183-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1173-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1185-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1175-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1182-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1166-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1171-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1192-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1184-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1190-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1161-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1172-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1158-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1178-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1159-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1169-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1160-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1162-05 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.

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

Timeline

57 dated events

  1. Recall initiated FDA recalls Z-0421-2014
  2. Recall initiated FDA recalls Z-0419-2014
  3. Recall initiated FDA recalls Z-0415-2014
  4. Recall initiated FDA recalls Z-0423-2014
  5. Recall initiated FDA recalls Z-0418-2014
  6. Listed FDA GUDID 10603295063926
  7. Cleared FDA 510(k) K241000
  8. Registered EUDAMED 0603295a003158J
  9. Certificate issued EUDAMED MDR 776531
  10. Certificate expires EUDAMED MDR 776531

47 earlier events are in the sections above.

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. Sigma
Generic name
Tibial insert
Device name
Fixed Bearing Tibial Insert
Model / Ref / Catalog
1581-21-008, SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert, 158121008
Primary DI / UDI-DI
10603295063926
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 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

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Tibial insert

Cleared under the same submission (K033272)

and 8 more cleared under K033272

Cleared under the same submission (K241000)

and 8 more cleared under K241000

Similar devices in this category

Other devices filed under BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)