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TaperFit Cemented Hip System 399.9320

by Corin Ltd

Ref 399.9320Model TriFit TS Hip Stem Instrument Set

TaperFit Cemented Hip System 399.9320 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-05055343883723), cleared under FDA 510(k) K142761 on 3 Apr 2015 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343883723), 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) K142761

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-05055343883723 Basic UDI-DI 05055343883723UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343883723 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142761 Date3 Apr 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343883723 registered 21 Oct 2026 Active
  • FDA 510(k) K142761 decided 3 Apr 2015 Active
  • FDA GUDID UDI-DI 05055343883723 listed 17 Aug 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1667-2022 FDA Class II initiated 12 Jul 2022

    Some of the devices did not pass fatigue testing.

Timeline

4 dated events

  1. Cleared FDA 510(k) K142761
  2. Listed FDA GUDID 05055343883723
  3. Recall initiated FDA recalls Z-1667-2022
  4. Registered EUDAMED B-05055343883723

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  • Withdrawn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
Box Osteotome EUDAMED
TaperFit Cemented Hip System GUDID
Generic name
Orthopaedic osteotome
Model / Ref / Catalog
399.9320, TriFit TS Hip Stem Instrument Set
Primary DI / UDI-DI
05055343883723
Basic UDI-DI
B-05055343883723
510(k) Number
FDA product code
JDI, JDG
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic osteotome
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3350, 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 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 osteotome

Cleared under the same submission (K142761)

and 8 more cleared under K142761

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)