P.F.C. Sigma 1581-05-010

• 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· +5 more in the status table
• FDA GUDID UDI-DI 10603295062738 listed 24 Sep 2015 Listed

• • 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.

• 12 recalls, same reason

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

  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.

• • 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.

• 51 recalls, same reason

  • Terminated Z-0407-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • Terminated Z-0403-2008 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-0406-2008 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-0402-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • 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-1318-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1183-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1320-05 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-1316-05 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-1319-05 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
  • 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-1317-05 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-1315-05 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

  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-0057-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006

  Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

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

1. 18 Nov 2013 Recall initiated FDA recalls Z-0413-2014
2. 18 Nov 2013 Recall initiated FDA recalls Z-0414-2014
3. 18 Nov 2013 Recall initiated FDA recalls Z-0415-2014
4. 18 Nov 2013 Recall initiated FDA recalls Z-0422-2014
5. 9 Dec 2013 Recall initiated FDA recalls Z-1077-2014
6. 24 Sep 2015 Listed FDA GUDID 10603295062738
7. 11 Jul 2024 Cleared FDA 510(k) K241000
8. 23 Dec 2025 Registered EUDAMED 0603295a003158J
9. 15 Jul 2026 Certificate issued EUDAMED MDR 776531
10. 11 Sep 2029 Certificate expires EUDAMED MDR 776531

66 earlier events are in the sections above.

Trade name

P.F.C. Sigma

Generic name

Tibial insert

Device name

Fixed Bearing Tibial Insert

Model / Ref / Catalog

1581-05-010, SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert, 158105010

Primary DI / UDI-DI

10603295062738

Basic UDI-DI

0603295a003158J

510(k) Number

K033272 ↗

K040166 ↗

K082500 ↗

K241000 ↗

K943462 ↗

K961685 ↗

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

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.

Category: Tibial insert

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

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• ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ E.7549-0405 by Zimed Medikal Sanayi ve Ticaret Limited Şirketi
• GMK Sphere Total Knee System 02.12.E0313CRR by Medacta International
• Unity Total Knee System 112.015.29 by CORIN LTD
• Unity Total Knee System 112.014.43 by CORIN LTD
• GMK Primary Total Knee System 02.07.0514SF by Medacta International
• APEX PS Knee KP-22410 by OMNIlife science, Inc.
• APEX Knee System EP-22513 by OMNIlife science, Inc.
• ZİMED MEDİKAL SAN VE TİCARET LİMİTED ŞİRKETİ 7549-0304 by Zimed Medikal Sanayi ve Ticaret Limited Şirketi

• Attune 1506-61-310

  Class III

  GUDID on market

• Attune 1506-61-320

  Class III

  GUDID on market

• Attune 1506-61-510

  Class III

  GUDID on market

• Attune 1506-61-520

  Class III

  GUDID on market

See all devices from Depuy (Ireland) →