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Arthrex® AR-4159-16D-1

by Arthrex, Inc.

Ref AR-4159-16D-1

Arthrex® AR-4159-16D-1 is a device classified as Class IIb in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 0888867NitKWires0000000HU) and listed in FDA GUDID since 27 Jul 2020 (UDI-DI 00888867335196), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888867NitKWires0000000HU Basic UDI-DI 00888867335196UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867335196 UDI-DI Date27 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867NitKWires0000000HU registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 00888867335196 listed 27 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867335196
  2. Registered EUDAMED 0888867NitKWires0000000HU

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Arthrex®
Generic name
Orthopaedic bone pin, non-bioabsorbable
Device name
Nitinol K-Wires
Model / Ref / Catalog
AR-4159-16D-1
Primary DI / UDI-DI
00888867335196
Basic UDI-DI
0888867NitKWires0000000HU
FDA product code
HTY
EMDN code
P09120101 Osteosynthesis staples
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 pin, non-bioabsorbable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS STAPLES.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)