Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Praxim S.A — 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) |
|---|---|---|---|---|---|
| K072267 | TOTAL HIP SURGETICS NAVIGATION SYSTEM | Praxim S.A | 2007-12-10 | 117 | 0 |
| K062146 | UNI KNEE SURGETICS NAVIGATION SYSTEM | Praxim S.A | 2006-08-21 | 25 | 0 |
| K060282 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM | Praxim S.A | 2006-04-10 | 66 | 0 |
| K053542 | SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM | Praxim S.A | 2006-04-10 | 111 | 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