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TriFit TS Blade Stem 695.462

by Corin Ltd

Ref 695.462Model TriFit TS Hip Stem Instrument Set

TriFit TS Blade Stem 695.462 is a device classified as Class I in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-05055343889930), cleared under FDA 510(k) K121563 on 5 Oct 2012 and listed in FDA GUDID since 21 Aug 2018 (UDI-DI 05055343889930), active as of 24 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) K121563

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343889930 Basic UDI-DI 05055343889930UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343889930 UDI-DI Date21 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121563 Date5 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343889930 registered 21 Oct 2026 Active
  • FDA 510(k) K121563 decided 5 Oct 2012 Active
  • FDA GUDID UDI-DI 05055343889930 listed 21 Aug 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-2603-2021 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) K121563
  2. Listed FDA GUDID 05055343889930
  3. Recall initiated FDA recalls Z-2603-2021
  4. Registered EUDAMED B-05055343889930

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  • Withdrawn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
Single Offset Handle EUDAMED
TriFit TS Blade Stem GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
695.462, TriFit TS Hip Stem Instrument Set
Primary DI / UDI-DI
05055343889930
Basic UDI-DI
B-05055343889930
510(k) Number
FDA product code
KWY, KWL, LZO, MEH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3390, 888.3360, 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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K121563)

and 8 more cleared under K121563

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)