Skip to content

XtraFix® Large External Fixation System 00-5205-050-35

by Zimmer, Inc.

Ref 00-5205-050-35

XtraFix® Large External Fixation System 00-5205-050-35 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 889024-ZB001205-EN), cleared under FDA 510(k) K113383 on 26 Jun 2012 and listed in FDA GUDID since 13 Jul 2016 (UDI-DI 00889024080973), 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) K113383

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 Number889024-ZB001205-EN Basic UDI-DI 00889024080973UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024080973 UDI-DI Date13 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113383 Date26 Jun 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB001205-EN registered 2 Nov 2026 Active
  • FDA 510(k) K113383 decided 26 Jun 2012 Active
  • FDA GUDID UDI-DI 00889024080973 listed 13 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113383
  2. Listed FDA GUDID 00889024080973
  3. Registered EUDAMED 889024-ZB001205-EN

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  • Withdrawn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
XtraFix® Large External Fixation System
Generic name
Orthopaedic bone pin, non-bioabsorbable
Device name
Mfx_xtra FIX_PIN_5MM Half 35mm Thd Blunt
Model / Ref / Catalog
00-5205-050-35
Primary DI / UDI-DI
00889024080973
Basic UDI-DI
889024-ZB001205-EN
510(k) Number
FDA product code
JDW
EMDN code
P09120499 External bone fixation systems - other
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
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 160 Millimeter

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

Cleared under the same submission (K113383)

and 8 more cleared under K113383

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)