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Trinity Acetabular Hip System 9210034

by Corin Ltd

Ref 9210034Model Trinity Acetabular System Instrument Set

Trinity Acetabular Hip System 9210034 is an orthopaedic implant impactor (EU MDD Class I; FDA Class II) made by Corin Ltd, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-05055343896112), cleared under FDA 510(k) K170359 on 31 Oct 2017 and listed in FDA GUDID since 8 Jan 2019 (UDI-DI 05055343896112), active as of 23 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) K170359

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343896112 Basic UDI-DI 05055343896112UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343896112 UDI-DI Date8 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170359 Date31 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343896112 registered 14 Oct 2026 Active
  • FDA 510(k) K170359 decided 31 Oct 2017 Active
  • FDA GUDID UDI-DI 05055343896112 listed 8 Jan 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-2608-2021 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) K170359
  2. Listed FDA GUDID 05055343896112
  3. Recall initiated FDA recalls Z-2608-2021
  4. Registered EUDAMED B-05055343896112

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  • Withdrawn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
Impactor Head (Size 2) EUDAMED
Trinity Acetabular Hip System GUDID
Generic name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
9210034, Trinity Acetabular System Instrument Set
Primary DI / UDI-DI
05055343896112
Basic UDI-DI
B-05055343896112
510(k) Number
FDA product code
MEH, LZO
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Orthopaedic implant impactor, reusable

Cleared under the same submission (K170359)

and 8 more cleared under K170359

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)