510(k) Report

FDA applicant

Progentix Orthobiology BV

Bilthoven, NL2 decisions2009–20150 recalls

FDA records 2 decisions for Progentix Orthobiology BV (Bilthoven, NL) from 2009 to 2015: 2 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 4 predicates, 1 of them its own earlier devices. 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 Progentix Orthobiology BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2009: 12015: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Progentix Orthobiology BV by year, 2009–2026Sources: 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

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 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.

  • K090641CuriosProgentix Orthobiology BV · 20094cite it
  • K151584AttraX PuttyProgentix Orthobiology BV · 20154cite it

What has FDA decided for it lately?

  • K151584AttraX PuttyProgentix Orthobiology BV · 2015
  • K090641CuriosProgentix Orthobiology BV · 2009

All 2 as Progentix Orthobiology BV →