Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Onkos Surgical — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
827 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN210058 | ELEOSx™ Limb Salvage System | Onkos Surgical | 2024-04-05 | 827 | 0 |
| K212815 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical | 2022-07-06 | 306 | 0 |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | 2021-07-28 | 57 | 0 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 | 162 | 3 |
| K203588 | ELEOS™ Limb Salvage System | Onkos Surgical | 2021-02-05 | 59 | 3 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 | 59 | 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