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Fragment Fixation System 1

by Orthofix, Inc. 6 variants

Ref W1221Model BONE FIXATION WIRES

Fragment Fixation System 1 (W1221) is a device classified as Class IIb in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436Wires2bNAC08RX), cleared under FDA 510(k) K944092 on 4 Apr 1995 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 18032568865363), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944092

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436Wires2bNAC08RX Basic UDI-DI 18032568865363UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032568865363 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944092 Date4 Apr 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436Wires2bNAC08RX registered 22 Oct 2026 Active
  • FDA 510(k) K944092 decided 4 Apr 1995 Active
  • FDA GUDID UDI-DI 18032568865363 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K944092
  2. Listed FDA GUDID 18032568865363
  3. Registered EUDAMED 805050436Wires2bNAC08RX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Fragment Fixation System
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
BONE FIXATION WIRES, W1221, 1
Primary DI / UDI-DI
18032568865363
Basic UDI-DI
805050436Wires2bNAC08RX
510(k) Number
FDA product code
JEC
EMDN code
P09120399 Bone fixation wires - other
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 120 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BONE FIXATION WIRES
W1221
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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 screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K944092)

and 8 more cleared under K944092

Similar devices in this category

Other devices filed under BONE FIXATION WIRES - OTHER.

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)