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Hoffmann 983031

by Stryker GmbH

Ref 983031Model 08858250000652S4

Hoffmann 983031 is a device classified as Class IIa in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 08858250000652S4), cleared under FDA 510(k) K163656 on 14 Apr 2017 and listed in FDA GUDID since 23 May 2018 (UDI-DI 07613327297751), active as of 12 Nov 2026. 5 FDA recalls are 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

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163656

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 Number08858250000652S4 Basic UDI-DI 07613327297751UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327297751 UDI-DI Date23 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163656 Date14 Apr 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858250000652S4 registered 14 Jul 2026 Active
  • FDA 510(k) K163656 decided 14 Apr 2017 Active
  • FDA GUDID UDI-DI 07613327297751 listed 23 May 2018 Listed

Recalls

5 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0291-2019 FDA Class II initiated 28 Aug 2018
    • Terminated Z-0288-2019 FDA Class II initiated 28 Aug 2018
    • Terminated Z-0289-2019 FDA Class II initiated 28 Aug 2018
    • Terminated Z-0290-2019 FDA Class II initiated 28 Aug 2018

    The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.

    • Terminated Z-3240-2018 FDA Class II initiated 26 Jul 2018

    When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.

Timeline

8 dated events

  1. Cleared FDA 510(k) K163656
  2. Listed FDA GUDID 07613327297751
  3. Recall initiated FDA recalls Z-3240-2018
  4. Recall initiated FDA recalls Z-0291-2019
  5. Recall initiated FDA recalls Z-0288-2019
  6. Recall initiated FDA recalls Z-0289-2019
  7. Recall initiated FDA recalls Z-0290-2019
  8. Registered EUDAMED 08858250000652S4

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
Hoffmann
Generic name
CAD/CAM software
Device name
Hlrf - Software - Class Iia
Model / Ref / Catalog
983031, 08858250000652S4
Primary DI / UDI-DI
07613327297751
Basic UDI-DI
08858250000652S4
510(k) Number
FDA product code
KTT
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
CAD/CAM software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3030
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: CAD/CAM software

Cleared under the same submission (K163656)

and 1 more cleared under K163656

Similar devices in this category

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

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)