Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopedic Designs, Inc. — 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) |
|---|---|---|---|---|---|
| K030619 | ODI 7.0MM CANNULATED SCREW SYSTEM | Orthopedic Designs, Inc. | 2003-04-01 | 33 | 0 |
| K014189 | ODI TALON INTRAMEDULLARY HIP NAIL | Orthopedic Designs, Inc. | 2002-03-21 | 90 | 0 |
| K984331 | ODI ULTIMATE COMPRESSION HIP SCREW | Orthopedic Designs, Inc. | 1999-01-20 | 48 | 0 |
| K972722 | ULTIMATE COMPRESSION SCREW SYSTEM | Orthopedic Designs, Inc. | 1998-01-23 | 186 | 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