Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Orthopedic Designs North America, 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) |
|---|---|---|---|---|---|
| K210146 | Cannulated Compression Device System | Orthopedic Designs North America, Inc. | 2022-04-13 | 447 | 0 |
| K173255 | Talon DistalFix Humeral Nail | Orthopedic Designs North America, Inc. | 2018-02-22 | 135 | 0 |
| K152295 | Talon DistalFix Antegrade/Retrograde Femoral Nail | Orthopedic Designs North America, Inc. | 2015-11-03 | 82 | 0 |
| K111352 | TALON DISTALFIX PROXIMAL FEMORAL NAIL | Orthopedic Designs North America, Inc. | 2011-08-22 | 101 | 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