510(k) Report

FDA applicant

Applied Osteo Systems, Inc.

Walnut Creek, CA15 decisions1990–19951 recall

FDA records 15 decisions for Applied Osteo Systems, Inc. (Walnut Creek, CA) from 1990 to 1995: 15 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and JDS (Nail, Fixation, Bone). 1 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 Applied Osteo Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Osteo Systems, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Applied Osteo Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Applied Osteo Systems, 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?

  • HSBRod, Fixation, Intramedullary And Accessories9decisions
  • JDSNail, Fixation, Bone1decision
  • KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component1decision
  • JELCurette, Biopsy, Bronchoscope (Rigid)1decision
  • JECComponent, Traction, Invasive1decision
  • LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite1decision

Also: HWC (1).

Who builds on its devices?

Later devices cite its devices 11 times; 0 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.

  • K941048True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 19944cite it
  • K902264True/Flex Humerus, Ulna and Radius IntramedullaryApplied Osteo Systems, Inc. · 19903cite it
  • K913949True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 19923cite it
  • K934148True/Flex Clavicle RodsApplied Osteo Systems, Inc. · 19941cites it

What has FDA decided for it lately?

  • K935383Femrod and Femrod Recon InsertApplied Osteo Systems, Inc. · 1995
  • K933995True/Flextm Femur Rods, Caps, Screws and InstrumentationApplied Osteo Systems, Inc. · 1995
  • K944501True/Flex Intramedullary Rod End-CapApplied Osteo Systems, Inc. · 1994
  • K941048True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 19941 recall
  • K943160Interference ScrewApplied Osteo Systems, Inc. · 1994
  • K932853Pin Holders, Transfixing Pins, OL Wires, Half PinsApplied Osteo Systems, Inc. · 1994
  • K934148True/Flex Clavicle RodsApplied Osteo Systems, Inc. · 1994
  • K931578Texas Scottish Rite Easy/Lock FixatorApplied Osteo Systems, Inc. · 1994

All 15 as Applied Osteo Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K941048Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded…Sep 28, 2007