510(k) Report

FDA applicant

Advanced Orthopaedic Solutions, Inc. (Aos)

Torrance, CA4 decisions2016–20180 recalls

FDA records 4 decisions for Advanced Orthopaedic Solutions, Inc. (Aos) (Torrance, CA) from 2016 to 2018: 4 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Advanced Orthopaedic Solutions, Inc. (Aos)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12017: 22018: 1
2016high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Advanced Orthopaedic Solutions, Inc. (Aos) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

Which product codes does it file in?

  • HRSPlate, Fixation, Bone2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 115 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 20171cites it
  • K161913AOS Small Fragment Plating SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 20161cites it
  • K181035AOS Small Fragment Plating System LiteAdvanced Orthopaedic Solutions, Inc. (Aos) · 20181cites it

What has FDA decided for it lately?

  • K181035AOS Small Fragment Plating System LiteAdvanced Orthopaedic Solutions, Inc. (Aos) · 2018
  • K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K161913AOS Small Fragment Plating SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2016

All 4 as Advanced Orthopaedic Solutions, Inc. (Aos) →