Skip to content

OTS Hip Solution Emphasys 1001

by Ortoma AB (Publ)

OTS Hip Solution Emphasys 1001 (10-103) is a Class II device made by Ortoma AB (Publ), cleared under FDA 510(k) K232140 on 11 Mar 2024 and listed in FDA GUDID since 1 Oct 2024 (UDI-DI 07350137520708), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K232140

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350137520708 UDI-DI Date1 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232140 Date11 Mar 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232140 decided 11 Mar 2024 Active
  • FDA GUDID UDI-DI 07350137520708 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

3 dated events

  1. Cleared FDA 510(k) K232140
  2. Listed FDA GUDID 07350137520708
  3. Recall initiated FDA recalls Z-2615-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OTS Hip Solution Emphasys
Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / Ref / Catalog
1001, 10-103
Primary DI / UDI-DI
07350137520708
510(k) Number
FDA product code
OLO
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Electromagnetic/optical surgical navigation device tracking system

Cleared under the same submission (K232140)

and 8 more cleared under K232140

Similar devices

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

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

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)