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Fragment Fixation System 1

by Orthofix, Inc. 6 variants

Ref 99-W2255Model BONE FIXATION WIRES

Fragment Fixation System 1 (99-W2255) 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 1 Sep 2015 (UDI-DI 18033509852619), 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 18033509852619UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033509852619 UDI-DI Date1 Sep 2015ListedStatusListed 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 18033509852619 listed 1 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K944092
  2. Listed FDA GUDID 18033509852619
  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  • Withdrawn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, sterile
Model / Ref / Catalog
BONE FIXATION WIRES, 99-W2255, 1
Primary DI / UDI-DI
18033509852619
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, 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
Size
Length — 120 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BONE FIXATION WIRES
99-W2255
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, 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

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)