Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neosteo — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
183 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212545 | FlexitSystem Knee osteotomy system | Neosteo | 2022-02-11 | 183 | 0 |
| K192447 | Superelastic Staple | Neosteo | 2020-02-28 | 175 | 0 |
| K191424 | Interphalangeal Joint Fusion Device Range | Neosteo | 2019-08-28 | 91 | 0 |
| K153182 | SELF- COMPRESSIVE SCREW | Neosteo | 2015-11-25 | 22 | 0 |
| K150772 | Snap-Off Self-Compressive Screw | Neosteo | 2015-05-08 | 45 | 0 |
| K131471 | SELF-COMPRESSIVE SCREW | Neosteo | 2013-08-28 | 98 | 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