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Trinity Acetabular Hip System 321.02.348

by Corin Ltd

Ref 321.02.348Model Trinity Acetabular Shells

Trinity Acetabular Hip System 321.02.348 is a device classified as Class III in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-05055196927452), cleared under FDA 510(k) K093472 on 23 Nov 2010 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055196927452), active as of 22 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093472

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055196927452 Basic UDI-DI 05055196927452UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055196927452 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093472 Date23 Nov 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055196927452 registered 22 Sep 2026 Active
  • FDA 510(k) K093472 decided 23 Nov 2010 Active
  • FDA GUDID UDI-DI 05055196927452 listed 17 Aug 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2604-2021 FDA Class II initiated 28 Jul 2021

    The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

Timeline

4 dated events

  1. Cleared FDA 510(k) K093472
  2. Listed FDA GUDID 05055196927452
  3. Recall initiated FDA recalls Z-2604-2021
  4. Registered EUDAMED B-05055196927452

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Trinity Multi Hole Shell Ø48mm Taper Size 2 EUDAMED
Trinity Acetabular Hip System GUDID
Generic name
Acetabular shell
Device name
Trinity Acetabular shells for use in Trinity Acetabular System
Model / Ref / Catalog
321.02.348, Trinity Acetabular Shells
Primary DI / UDI-DI
05055196927452
Basic UDI-DI
B-05055196927452
510(k) Number
FDA product code
MEH, LZO, LWJ
EMDN code
P090803010201 Primary implant uncemented metal acetabular cups
GMDN term
Acetabular shell
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3360
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05055196927452: EUDAMED states No, FDA GUDID states Yes.

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: Acetabular shell

Cleared under the same submission (K093472)

and 8 more cleared under K093472

Similar devices in this category

Other devices filed under PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)