Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopaedic Innovations, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
438 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020145 | ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM | Orthopaedic Innovations, Inc. | 2002-04-15 | 89 | 0 |
| K983881 | COBRA EXTERNAL FIXATOR | Orthopaedic Innovations, Inc. | 1998-12-04 | 32 | 0 |
| K962646 | PRIME MODULAR ENDO HEAD | Orthopaedic Innovations, Inc. | 1996-09-23 | 77 | 0 |
| K960014 | PRACTIFIX EXTERNAL FIXATION SYSTEM | Orthopaedic Innovations, Inc. | 1996-03-18 | 76 | 0 |
| K955620 | PRIME CEMENTED CALCAR FEMORAL STEMS | Orthopaedic Innovations, Inc. | 1996-02-20 | 71 | 0 |
| K955751 | PRIME FEMORAL CEMENT PLUG | Orthopaedic Innovations, Inc. | 1996-01-26 | 37 | 0 |
| K953033 | PRIME CEMENTED SMALL FEMORAL STEM | Orthopaedic Innovations, Inc. | 1995-09-13 | 75 | 0 |
| K940328 | PRIME CEMENTED HIP SYSTEM | Orthopaedic Innovations, Inc. | 1995-04-07 | 438 | 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