Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hand Innovations, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
90 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | Hand Innovations, Inc. | 2005-04-26 | 12 | 1 |
| K042059 | SHOULDER FIXATION SYSTEM | Hand Innovations, Inc. | 2004-09-30 | 62 | 0 |
| K041157 | MODIFICATION TO SMALL BONE FIXATION SYSTEM | Hand Innovations, Inc. | 2004-07-30 | 88 | 0 |
| K041081 | FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES | Hand Innovations, Inc. | 2004-07-01 | 66 | 1 |
| K033406 | SMALL BONE FIXATION SYSTEM | Hand Innovations, Inc. | 2004-01-15 | 83 | 0 |
| K032705 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2003-10-01 | 29 | 0 |
| K030198 | HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2003-04-01 | 70 | 0 |
| K023007 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2002-12-05 | 87 | 0 |
| K013424 | INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND | Hand Innovations, Inc. | 2001-12-20 | 66 | 0 |
| K002775 | DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2000-12-05 | 90 | 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