510(k) Report

FDA applicant

Graftys

Aix En Provence, FR5 decisions2008–20230 recalls

FDA records 5 decisions for Graftys (Aix En Provence, FR) from 2008 to 2023: 5 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 7 predicates, 3 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 Graftys’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12009: 22010: 12023: 1
2008high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Graftys by year, 2008–2026Sources: 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 Compound4decisions
  • LYCBone Grafting Material, Synthetic1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K082498Graftys HBSGraftys · 20091cites it
  • K093343Grafty QuicksetGraftys · 20101cites it
  • K082286BioactysGraftys · 20091cites it
  • K073064Graftys BCPGraftys · 20081cites it

What has FDA decided for it lately?

All 5 as Graftys →