Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopaedic Device Corp. — 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) |
|---|---|---|---|---|---|
| K870234 | P.T.H. METAL-BACKED ACETABULAR CUP | Orthopaedic Device Corp. | 1987-03-20 | 58 | 0 |
| K862460 | FEMORAL HEMI-HIP PROSTHESIS | Orthopaedic Device Corp. | 1986-10-06 | 98 | 0 |
| K863343 | SUPERFIXATION(TM) | Orthopaedic Device Corp. | 1986-09-15 | 17 | 0 |
| K855228 | FEMORAL HEMI-HIP PROSTHESES | Orthopaedic Device Corp. | 1986-02-11 | 43 | 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