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OTS Hip Guide SW 5

by Ortoma AB (Publ)

Ref 20-100

OTS Hip Guide SW 5 (20-100) is a medical device (EU MDR Class IIb; FDA Class II; FDA product code OLO, Orthopedic Stereotaxic Instrument; EMDN category surgical navigation system) made by Ortoma AB (Publ), registered in EUDAMED on 19 May 2026 (Basic UDI-DI 735013752OTSHipGuideQN), cleared under FDA 510(k) K232140 on 11 Mar 2024 and listed in FDA GUDID since 1 Oct 2024 (UDI-DI 07350137520029), active as of 25 Oct 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232140

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735013752OTSHipGuideQN Basic UDI-DI 07350137520029UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350137520029 UDI-DI Date1 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232140 Date11 Mar 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735013752OTSHipGuideQN registered 19 May 2026 Active
  • FDA 510(k) K232140 decided 11 Mar 2024 Active
  • FDA GUDID UDI-DI 07350137520029 listed 1 Oct 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2615-2025 FDA Class II initiated 28 Jul 2025

    Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

Timeline

4 dated events

  1. Cleared FDA 510(k) K232140
  2. Listed FDA GUDID 07350137520029
  3. Recall initiated FDA recalls Z-2615-2025
  4. Registered EUDAMED 735013752OTSHipGuideQN

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  • Withdrawn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
OTS™ Hüftführungs-Software EUDAMED
OTS Hip Guide SW GUDID
Generic name
Electromagnetic/optical surgical navigation/tracking system
Device name
OTS Hip Guide Software
Model / Ref / Catalog
20-100, 5
Primary DI / UDI-DI
07350137520029
Basic UDI-DI
735013752OTSHipGuideQN
510(k) Number
FDA product code
OLO
EMDN code
Z12011401 Surgical navigation system
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
Special device type
Software
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
20-100
GUDID
5
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: Electromagnetic/optical surgical navigation device tracking system

Cleared under the same submission (K232140)

and 8 more cleared under K232140

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Ortoma AB (Publ)

  • Pointer OT 1002 Open recall

    Class II

  • Stylet and Pin 1003 Open recall

    Class II

  • Reamer Adapter OTD 1003 Open recall

    Class II

  • Inserter Adapter OTD Straight 1002 Open recall

    Class II

See all devices from Ortoma AB (Publ) →

Properties

  • Measuring function
  • Prescription use
Other properties (23, all answered No)