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TaperFit Cemented Hip System 588.3800

by Corin Ltd

Ref 588.3800Model TaperFit Standard Stem

TaperFit Cemented Hip System 588.3800 is a device classified as Class III in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI B-05055343871065), cleared under FDA 510(k) K142761 on 3 Apr 2015 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343871065), 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) K142761

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-05055343871065 Basic UDI-DI 05055343871065UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343871065 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-05055343871065 registered 28 Sep 2026 Active
  • FDA 510(k) K142761 decided 3 Apr 2015 Active
  • FDA GUDID UDI-DI 05055343871065 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 05055343871065
  3. Recall initiated FDA recalls Z-1667-2022
  4. Registered EUDAMED B-05055343871065

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  • Withdrawn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
TaperFit Stem 38mm Offset – Size 0 - 1-hole variant + 188.550 PMMA Stem Centralizer EUDAMED
TaperFit Cemented Hip System GUDID
Generic name
Uncoated hip femur prosthesis, modular
Device name
TaperFit Stem for use in total hip arthroplasty and hemiarthroplasty
Model / Ref / Catalog
588.3800, TaperFit Standard Stem
Primary DI / UDI-DI
05055343871065
Basic UDI-DI
B-05055343871065
510(k) Number
FDA product code
JDI, JDG
EMDN code
P090804010101 Cemented femoral stems for primary implant, with fixed neck, straight
GMDN term
Uncoated hip femur prosthesis, modular
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3350, 888.3360
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05055343871065: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class III 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: Uncoated hip femur prosthesis, modular

Cleared under the same submission (K142761)

and 8 more cleared under K142761

Similar devices in this category

Other devices filed under CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)