510(k) Report

FDA applicant

Bonesupport AB

Lund, SE7 decisions2005–20240 recalls

FDA records 7 decisions for Bonesupport AB (Lund, SE) from 2005 to 2024: 6 510(k) clearances and 1 De Novo grant. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and QRR (Filler, Bone Void, Calcium Compound Containing…). Its devices cite 12 predicates, 4 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 Bonesupport AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2008: 12009: 12020: 12022: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bonesupport AB 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 Compound5decisions
  • QRRFiller, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside2decisions

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K051951Cerament Bone Void FillerBonesupport AB · 20052cite it
  • K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 20082cite it
  • K201535Cerament Bone Void FillerBonesupport AB · 20202cite it
  • K090871Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB · 20091cites it
  • DEN210044Cerament GBonesupport AB · 20221cites it

What has FDA decided for it lately?

  • K234008Cerament GBonesupport AB · 2024
  • K240459Cerament Bone Void FillerBonesupport AB · 2024
  • DEN210044Cerament GBonesupport AB · 2022
  • K201535Cerament Bone Void FillerBonesupport AB · 2020
  • K090871Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB · 2009
  • K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
  • K051951Cerament Bone Void FillerBonesupport AB · 2005

All 7 as Bonesupport AB →