510(k) Report

FDA applicant

Biomatlante

Vigneux De Bretagne, FR8 decisions2003–20101 recall

FDA records 8 decisions for Biomatlante (Vigneux De Bretagne, FR) from 2003 to 2010: 8 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 16 predicates, 7 of them its own earlier devices. 1 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 Biomatlante’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 22010: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biomatlante 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
  • LYCBone Grafting Material, Synthetic3decisions

Whose devices does it build on?

Its devices cite 16 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 7 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.

  • K051885MBCPBiomatlante · 200514cite it
  • K032268MBCPBiomatlante · 200311cite it
  • K051774MBCPBiomatlante · 200610cite it
  • K043005Modification to MBCPBiomatlante · 20056cite it
  • K060732MBCP GelBiomatlante · 20063cite it

What has FDA decided for it lately?

All 8 as Biomatlante →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063527OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single…Jan 31, 2011