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Metafix Hip Stem 340.431H

by Corin Ltd

Ref 340.431HModel MetaFix Hip Stem Instrument Set

Metafix Hip Stem 340.431H is a device classified as Class IIa in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-05055343891575), cleared under FDA 510(k) K153381 on 21 Jan 2016 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055343891575), 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153381

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-05055343891575 Basic UDI-DI 05055343891575UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343891575 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153381 Date21 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343891575 registered 21 Oct 2026 Active
  • FDA 510(k) K153381 decided 21 Jan 2016 Active
  • FDA GUDID UDI-DI 05055343891575 listed 16 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1509-2022 FDA Class II initiated 22 Jul 2022

    One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.

Timeline

4 dated events

  1. Cleared FDA 510(k) K153381
  2. Listed FDA GUDID 05055343891575
  3. Recall initiated FDA recalls Z-1509-2022
  4. Registered EUDAMED B-05055343891575

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  • Withdrawn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
MetaFix Male Broach Size 1 EUDAMED
Metafix Hip Stem GUDID
Generic name
Orthopaedic broach
Model / reference
340.431H, MetaFix Hip Stem Instrument Set
Primary DI / UDI-DI
05055343891575
Basic UDI-DI
B-05055343891575
510(k) Number
FDA product code
MEH, OQI, JDI, KWY, KWL, LZO
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic broach
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3350, 888.3390, 888.3360
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
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: Orthopaedic broach

Cleared under the same submission (K153381)

and 8 more cleared under K153381

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)