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Trinity Acetabular Hip System 921506

by Corin Ltd

Ref 921506Model Trinity Acetabular System Instrument Set

Trinity Acetabular Hip System 921506 is a device classified as Class IIa in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-05056139232473), cleared under FDA 510(k) K093472 on 23 Nov 2010 and listed in FDA GUDID since 2 May 2019 (UDI-DI 05056139232473), 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-05056139232473 Basic UDI-DI 05056139232473UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139232473 UDI-DI Date2 May 2019ListedStatusListed 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-05056139232473 registered 14 Oct 2026 Active
  • FDA 510(k) K093472 decided 23 Nov 2010 Active
  • FDA GUDID UDI-DI 05056139232473 listed 2 May 2019 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 05056139232473
  3. Recall initiated FDA recalls Z-2604-2021
  4. Registered EUDAMED B-05056139232473

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Trinity™ Drill Ø3.2. L 70mm EUDAMED
Trinity Acetabular Hip System GUDID
Generic name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
921506, Trinity Acetabular System Instrument Set
Primary DI / UDI-DI
05056139232473
Basic UDI-DI
B-05056139232473
510(k) Number
FDA product code
MEH, LZO, LWJ
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa 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
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Fluted surgical drill bit, reusable

Cleared under the same submission (K093472)

and 8 more cleared under K093472

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)