510(k) Report

FDA applicant

Biogeneration

Lakeland, TN2 decisions1998–20030 recalls

FDA records 2 decisions for Biogeneration (Lakeland, TN) from 1998 to 2003: 2 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). 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 Biogeneration’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biogeneration since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biogeneration 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 Compound2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K973704Profusion Bone Void FillerBiogeneration · 19981cites it
  • K031838Profusion Bone Void Filler KitBiogeneration · 20031cites it

What has FDA decided for it lately?

  • K031838Profusion Bone Void Filler KitBiogeneration · 2003
  • K973704Profusion Bone Void FillerBiogeneration · 1998

All 2 as Biogeneration →