Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Orthopaedic Solutions, Inc. (Aos) · 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) |
|---|---|---|---|---|---|
| K181035 | AOS Small Fragment Plating System Lite | Advanced Orthopaedic Solutions, Inc. (Aos) | 2018-08-24 | 128 | 0 |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 | 21 | 0 |
| K163014 | AOS Small Bone Nailing System | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-01-24 | 88 | 0 |
| K161913 | AOS Small Fragment Plating System | Advanced Orthopaedic Solutions, Inc. (Aos) | 2016-11-04 | 115 | 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