510(k) Report

FDA applicant

Nanotherapeutics

Alachua, FL4 decisions2007–20152 recalls

FDA records 4 decisions for Nanotherapeutics (Alachua, FL) from 2007 to 2015: 4 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 6 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Nanotherapeutics, Inc.”.

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

FDA decisions per year

1in 2015

2007: 12011: 12012: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Nanotherapeutics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound4decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K062459Origen DBM with Bioactive GlassNanotherapeutics · 20073cite it
  • K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc. · 20111cites it
  • K120279Nanofuse DBMNanotherapeutics · 20121cites it
  • K142104Nanofuse DBMNanotherapeutics, Inc. · 20151cites it

What has FDA decided for it lately?

  • K142104Nanofuse DBMNanotherapeutics, Inc. · 2015
  • K120279Nanofuse DBMNanotherapeutics · 2012
  • K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc. · 20112 recalls
  • K062459Origen DBM with Bioactive GlassNanotherapeutics · 2007

All 2 as Nanotherapeutics →All 2 as Nanotherapeutics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K110976Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and…Mar 10, 2011
  • K110976Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By…Mar 10, 2011