Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Onkos Surgical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
259 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | 2026-06-08 | 259 | 0 |
| K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | 2025-10-15 | 33 | 0 |
| K223348 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical, Inc. | 2023-01-30 | 89 | 0 |
| K180130 | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | 2018-02-23 | 37 | 0 |
| K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016-10-28 | 148 | 8 |
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