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TaperFit Cemented Hip System 588.3804

by Corin Ltd

Ref 588.3804Model TaperFit Standard Stem

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343868492 Basic UDI-DI 05055343868492UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343868492 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

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

    Some of the devices did not pass fatigue testing.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TaperFit Stem 38mm Offset – Size 4 - 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
588.3804, TaperFit Standard Stem
Primary DI / UDI-DI
05055343868492
Basic UDI-DI
B-05055343868492
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 market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Uncoated hip femur prosthesis, modular

Cleared under the same submission (K142761)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No