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Truelok System 1

by Orthofix SRL 4 variants

Part of a family of 430 devices: see the family page

Ref 50-1010MModel BONE FIXATION SYSTEMS, EXTERNAL

Truelok System 1 (50-1010M) is a device classified as Class I in the EU and Class II in the US made by Orthofix SRL, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 805050436ExFix1NACDB), cleared under FDA 510(k) K941048 on 3 Oct 1994 and listed in FDA GUDID since 24 Apr 2018 (UDI-DI 18056099649629), active as of 12 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K941048

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436ExFix1NACDB Basic UDI-DI 18056099649629UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18056099649629 UDI-DI Date24 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK941048 Date3 Oct 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436ExFix1NACDB registered 2 Nov 2026 Active
  • FDA 510(k) K941048 decided 3 Oct 1994 Active
  • FDA GUDID UDI-DI 18056099649629 listed 24 Apr 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-0674-2008 FDA Unclassified (pre-2012) initiated 28 Sep 2007

    Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.

Timeline

4 dated events

  1. Cleared FDA 510(k) K941048
  2. Recall initiated FDA recalls Z-0674-2008
  3. Listed FDA GUDID 18056099649629
  4. Registered EUDAMED 805050436ExFix1NACDB

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  • Withdrawn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
Truelok/Truelok Plus (Tl/Tl Plus) EUDAMED
Truelok System GUDID
Generic name
Implantable bone nut
Model / Ref / Catalog
BONE FIXATION SYSTEMS, EXTERNAL, 50-1010M, 1
Primary DI / UDI-DI
18056099649629
Basic UDI-DI
805050436ExFix1NACDB
510(k) Number
FDA product code
LXT
EMDN code
P0912040101 Radial bone fixation systems
GMDN term
Implantable bone nut
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BONE FIXATION SYSTEMS, EXTERNAL
50-1010M
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class I 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: Implantable bone nut

Cleared under the same submission (K941048)

and 8 more cleared under K941048

Similar devices

Also classified as Implantable bone nut.

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)