510(k) Report

FDA applicant

Kasios Biomaterials

Temecula, CA1 decision2004–20041 recall

FDA records 1 decision for Kasios Biomaterials (Temecula, CA) in 2004: 1 510(k) clearance. All are in product code MQV (Filler, Bone Void, Calcium Compound). 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 Kasios Biomaterials’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kasios Biomaterials since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K042340Kasios TCPKasios Biomaterials · 20043cite it

What has FDA decided for it lately?

  • K042340Kasios TCPKasios Biomaterials · 20041 recall

The one decision as Kasios Biomaterials →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042340OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and…Dec 5, 2016Class II

Other applicant names beginning “Kasios”

FDA records each applicant name separately; these may or may not be the same firm.

Kasios 1