Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Artos Medical Products GmbH · 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) |
|---|---|---|---|---|---|
| K962034 | SC, CEMENTLESS HIP SYSTEM | Artos Medical Products GmbH | 1996-10-23 | 152 | 0 |
| K962268 | CHROME COBALT BALL HEAD | Artos Medical Products GmbH | 1996-10-23 | 132 | 0 |
| K962086 | CPS, CEMENTED CUP SYSTEM | Artos Medical Products GmbH | 1996-08-07 | 70 | 0 |
| K961899 | CPS, CEMENTED HIP SYSTEM | Artos Medical Products GmbH | 1996-08-01 | 77 | 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