510(k) Report

FDA applicant

Advanced Biomaterials

St. Jeannet, FR3 decisions2004–20050 recalls

FDA records 3 decisions for Advanced Biomaterials (St. Jeannet, FR) from 2004 to 2005: 3 510(k) clearances. All are in product code HWC (Screw, Fixation, Bone). Its devices cite 6 predicates, 0 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 Advanced Biomaterials’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Biomaterials since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Biomaterials by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Biomaterials’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050468Triabsorb Composite ScrewAdvanced Biomaterials · 2005
  • K032830Plla Cannulated Interference ScrewAdvanced Biomaterials · 2004
  • K033749Titanium Cannulated Interference ScrewAdvanced Biomaterials · 2004

All 3 as Advanced Biomaterials →