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K-Wire 110025493

by Biomet Orthopedics, Inc.

Ref 110025493

K-Wire 110025493 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00887868469565), cleared under FDA 510(k) K190035 on 7 Feb 2019 (1 earlier submission) and listed in FDA GUDID since 24 Mar 2021 (UDI-DI 00887868469565), active as of 7 Nov 2026. 2 FDA recalls are 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190035

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868469565 Basic UDI-DI 00887868469565UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868469565 UDI-DI Date24 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK190035 Date7 Feb 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868469565 registered 23 Oct 2026 Active
  • FDA 510(k) K190035 decided 7 Feb 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868469565 listed 24 Mar 2021 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1302-2019 FDA Class II initiated 28 Mar 2019
    • Terminated Z-1303-2019 FDA Class II initiated 28 Mar 2019

    There is a potential of fracture, bending or shearing of the driver.

Timeline

6 dated events

  1. Cleared FDA 510(k) K142658
  2. Cleared FDA 510(k) K190035
  3. Recall initiated FDA recalls Z-1302-2019
  4. Recall initiated FDA recalls Z-1303-2019
  5. Listed FDA GUDID 00887868469565
  6. Registered EUDAMED B-00887868469565

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  • Withdrawn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
K-Wire
Generic name
Orthopaedic bone wire
Device name
MFA_Forefoot FRS_K-Wire ST
Model / Ref / Catalog
110025493
Primary DI / UDI-DI
00887868469565
Basic UDI-DI
B-00887868469565
510(k) Number
FDA product code
HWC
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic bone wire
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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 bone wire

Cleared under the same submission (K142658)

and 8 more cleared under K142658

Cleared under the same submission (K190035)

and 8 more cleared under K190035

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)