Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Ortomed Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
219 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842466 | TITANIUM MITTELMEIER TYPE ACETABULAR | American Ortomed Corp. | 1985-01-30 | 219 | 0 |
| K842518 | UNILOC-CEMENTLESS & SELF TAP ACETABULAR | American Ortomed Corp. | 1985-01-30 | 204 | 0 |
| K842465 | UNILOC | American Ortomed Corp. | 1984-11-19 | 147 | 0 |
| K840413 | CEMENT RESTRICTOR | American Ortomed Corp. | 1984-03-05 | 34 | 0 |
| K820719 | THE ICR KNEE | American Ortomed Corp. | 1982-05-12 | 57 | 0 |
| K780497 | SPHERISTEM TOTAL HIP PROSTHESIS | American Ortomed Corp. | 1978-06-14 | 78 | 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