Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Ortoma with 4 510(k) clearances, 2 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Jul 1, 2026: OTS Hip.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 1, 2026 | OTS HipK261852 · OLO | 510(k) clearances |
| Jul 28, 2025 | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter Class II · Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. | Device recalls |
| May 16, 2025 | OTS HipK250086 · OLO | 510(k) clearances |
| May 16, 2025 | OTS HipK250086 · Neurology | AI-enabled devices |
| Mar 11, 2024 | OTS HipK232140 · OLO | 510(k) clearances |
| Mar 11, 2024 | OTS HipK232140 · Neurology | AI-enabled devices |
| Sep 19, 2018 | Ortoma Treatment Solution - OTSK181449 · OLO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
