510(k) Report

FDA applicant

Sciences ET Bio Materiaux (Sbm)

Lourdes, FR2 decisions2003–20101 recall

FDA records 2 decisions for Sciences ET Bio Materiaux (Sbm) (Lourdes, FR) from 2003 to 2010: 2 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and HRS (Plate, Fixation, Bone). Its devices cite 3 predicates, 0 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 Sciences ET Bio Materiaux (Sbm)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sciences ET Bio Materiaux (Sbm) 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 Compound1decision
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 0 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.

  • K021963Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 20038cite it
  • K100604Otis -C PlusSciences ET Bio Materiaux (Sbm) · 20102cite it

What has FDA decided for it lately?

  • K100604Otis -C PlusSciences ET Bio Materiaux (Sbm) · 2010
  • K021963Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 20031 recall

All 2 as Sciences ET Bio Materiaux (Sbm) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021963Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95%…Apr 7, 2025Class II

Other applicant names beginning “Sciences”

FDA records each applicant name separately; these may or may not be the same firm.

Sciences For Bio Materials 2