Ortoma AB

Gothenburg Vastra Gotaland, SE

ORTOMA AB appears in FDA device records in Gothenburg Vastra Gotaland, SE. FDA records list 4 510(k) clearances between 2018-09-19 and 2026-07-01, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 4 510(k) clearances for Ortoma AB between 2018 and 2026. The busiest year on record is 2018, with 1. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Ortoma AB, by decision year
Year	Clearances
2018	1
2024	1
2025	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K261852	OTS Hip	OLO	Substantially Equivalent	2026-07-01
K250086	OTS Hip	OLO	Substantially Equivalent	2025-05-16
K232140	OTS Hip	OLO	Substantially Equivalent	2024-03-11
K181449	Ortoma Treatment Solution - OTS	OLO	Substantially Equivalent	2018-09-19

Registered establishments

FDA registered establishments for Ortoma AB, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3014411622	3014411622	ORTOMA AB	Falkenbergsgatan 3, Gothenburg Vastra Gotaland 41285 SE	2026	OLO

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

OLOOrthopedic Stereotaxic Instrument

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2615-2025	Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.	Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.	Class II	2025-07-28	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain