510(k) Report

FDA applicant

Sbm Sciences For Bio Materials

Lourdes, FR4 decisions2012–20180 recalls

FDA records 4 decisions for Sbm Sciences For Bio Materials (Lourdes, FR) from 2012 to 2018: 4 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “S.B.M. Sas Sciences For Bio Materials”.

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 Sbm Sciences For Bio Materials’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2012: 12013: 12015: 12018: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Sbm Sciences For Bio Materials by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sbm Sciences For Bio Materials’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?

  • MAIFastener, Fixation, Biodegradable, Soft Tissue2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • MQVFiller, Bone Void, Calcium Compound1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials · 20152cite it
  • K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials · 20181cites it
  • K122228Ligafix Interference ScrewSbm Sciences For Bio Materials · 20121cites it

What has FDA decided for it lately?

  • K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials · 2018
  • K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials · 2015
  • K130953Neotis; Neotis 50Sbm Sciences For Bio Materials · 2013
  • K122228Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012

All 3 as Sbm Sciences For Bio Materials →The one decision as S.B.M. Sas Sciences For Bio Materials →