Skip to content

Na 1363-43-000

by Depuy Orthopaedics, Inc.

Ref 1363-43-000Model DEPUY SYNTHES Modular Cathcart Fracture Head Hip Ball

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

CE MDR

Valid until

17 Aug 2030

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

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 Number0603295a004018C Basic UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295032755 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781955 Active Supplemented

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    17 Aug 2030
    Reason
    Change approved

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1375-2022 FDA Class II initiated 18 May 2022

    The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.

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  • Withdrawn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

Generic Name
Femoral head/stem prosthesis adaptor
Model / Ref / Catalog
1363-43-000, DEPUY SYNTHES Modular Cathcart Fracture Head Hip Ball, 136343000
Primary DI / UDI-DI
10603295032755
Basic UDI-DI
0603295a004018C
510(k) Number
FDA Product Code
LZY
EMDN Code
P090804050102 Metal femoral heads, partial hip replacement
GMDN Term
Femoral head/stem prosthesis adaptor
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3360
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Femoral head/stem prosthesis adaptor

Cleared under the same submission (K903084)

Show all (12)

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

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

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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