510(k) Report

FDA applicant

Biostructures, LLC

Newport Beach, CA5 decisions2010–20161 recall

FDA records 5 decisions for Biostructures, LLC (Newport Beach, CA) from 2010 to 2016: 5 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 12 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Biostructures”.

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 Biostructures, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010: 12011: 12014: 12015: 12016: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2010high 1 (2019) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Biostructures, LLC by year, 2010–2026Sources: 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 Compound5decisions

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K112857Interface Bone Void FillerBiostructures, LLC · 20112cite it
  • K132071Bioactive Bone Graft PuttyBiostructures, LLC · 20142cite it
  • K142276MCS Bone GraftBiostructures, LLC · 20152cite it
  • K092541InterfaceBiostructures · 20101cites it
  • K160446MCP Bone PuttyBiostructures, LLC · 20161cites it

What has FDA decided for it lately?

  • K160446MCP Bone PuttyBiostructures, LLC · 2016
  • K142276MCS Bone GraftBiostructures, LLC · 2015
  • K132071Bioactive Bone Graft PuttyBiostructures, LLC · 20141 recall
  • K112857Interface Bone Void FillerBiostructures, LLC · 2011
  • K092541InterfaceBiostructures · 2010

All 4 as Biostructures, LLC →The one decision as Biostructures →

What has been recalled?

1 recall linked to its devices; the latest:

  • K132071BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use…Feb 13, 2019Class II