Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortoma AB — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 | 28 | 0 |
| K250086 | OTS Hip | Ortoma AB | 2025-05-16 | 123 | 1 |
| K232140 | OTS Hip | Ortoma AB | 2024-03-11 | 237 | 1 |
| K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018-09-19 | 110 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda