Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medartis, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 | 27 | 0 |
| K052061 | MODUS IMF SCREWS 2.0 | Medartis, Inc. | 2005-10-21 | 84 | 0 |
| K051567 | APTUS TITANIUM OSTEOSYNTHESIS SYSTEM | Medartis, Inc. | 2005-08-23 | 70 | 1 |
| K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | Medartis, Inc. | 2005-08-22 | 35 | 0 |
| K050934 | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM | Medartis, Inc. | 2005-05-05 | 21 | 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