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Orthofix Modulsystem 1

by Orthofix SRL 443 variants

Ref 99-91000

Orthofix Modulsystem 1 (99-91000) is a device classified as Class I in the EU and Class II in the US made by Orthofix SRL, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-18032568863307), cleared under FDA 510(k) K955848 on 20 Mar 1996 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 18032568863307), active as of 12 Nov 2026. 23 FDA recalls are linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

23 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K955848

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/MDD EUDAMED NumberB-18032568863307 Basic UDI-DI 18032568863307UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032568863307 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK955848 Date20 Mar 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-18032568863307 registered 7 Oct 2026 Active
  • FDA 510(k) K955848 decided 20 Mar 1996 Active
  • FDA GUDID UDI-DI 18032568863307 listed 1 Sep 2015 Listed

Recalls

23 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0390-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0375-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0382-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0383-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0374-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0373-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0393-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0379-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0391-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0384-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0381-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0392-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0377-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0378-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0387-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0386-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0385-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0376-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0380-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0388-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0389-2020 FDA Class II initiated 27 Sep 2018

    As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

  • 2 recalls, same reason

    • Terminated Z-1435-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010
    • Terminated Z-1434-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.

Timeline

26 dated events

  1. Recall initiated FDA recalls Z-0377-2020
  2. Recall initiated FDA recalls Z-0378-2020
  3. Recall initiated FDA recalls Z-0387-2020
  4. Recall initiated FDA recalls Z-0386-2020
  5. Recall initiated FDA recalls Z-0385-2020
  6. Recall initiated FDA recalls Z-0376-2020
  7. Recall initiated FDA recalls Z-0380-2020
  8. Recall initiated FDA recalls Z-0388-2020
  9. Recall initiated FDA recalls Z-0389-2020
  10. Registered EUDAMED B-18032568863307

16 earlier events are in the sections above.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Xcaliber External Fixator EUDAMED
Orthofix Modulsystem GUDID
Generic name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
99-91000, 1
Primary DI / UDI-DI
18032568863307
Basic UDI-DI
B-18032568863307
510(k) Number
FDA product code
JDW
EMDN code
P0912040101 Radial bone fixation systems
GMDN term
External orthopaedic fixation system noninvasive component, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
99-91000
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

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: External orthopaedic fixation system, single-use

Cleared under the same submission (K955848)

and 8 more cleared under K955848

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

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)