FDA applicant
Advanced Orthopaedic Solutions, Inc.
FDA records 24 decisions for Advanced Orthopaedic Solutions, Inc. (Torrance, CA) from 2001 to 2020: 24 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 41 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 61 predicates, 26 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Advanced Orthopaedic Solutions”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Advanced Orthopaedic Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
12in 2010
Class I Class II/III not classified
Planning a device like Advanced Orthopaedic Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report