510(k) Report

FDA applicant

Ortoma AB

Gothenburg, SE4 decisions2018–20261 recall

FDA records 4 decisions for Ortoma AB (Gothenburg, SE) from 2018 to 2026: 4 510(k) clearances. All are in product code OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Ortoma AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12024: 12025: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2018high 1 (2025) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Ortoma AB by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ortoma AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K232140OTS HipOrtoma AB · 20241cites it
  • K181449Ortoma Treatment Solution - OTSOrtoma AB · 20181cites it
  • K250086OTS HipOrtoma AB · 20251cites it

What has FDA decided for it lately?

  • K261852OTS HipOrtoma AB · 2026
  • K250086OTS HipOrtoma AB · 20251 recall
  • K232140OTS HipOrtoma AB · 20241 recall
  • K181449Ortoma Treatment Solution - OTSOrtoma AB · 2018

All 4 as Ortoma AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K232140Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001…Jul 28, 2025Class II