510(k) Report

FDA applicant

Aap Biomaterials GmbH & Co. KG

Dieburg, DE4 decisions2009–20131 recall

FDA records 4 decisions for Aap Biomaterials GmbH & Co. KG (Dieburg, DE) from 2009 to 2013: 4 510(k) clearances. Most are in product codes LOD (Bone Cement) and NDN (Cement, Bone, Vertebroplasty). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Aap Biomaterials GmbH”.

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 Aap Biomaterials GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2009: 12012: 12013: 2
2009high 2 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2009high 1 (2022) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Aap Biomaterials GmbH & Co. KG by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aap Biomaterials GmbH & Co. KG’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?

  • LODBone Cement2decisions
  • NDNCement, Bone, Vertebroplasty2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K090460Bonos InjectAap Biomaterials GmbH · 20092cite it

What has FDA decided for it lately?

  • K123225Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60Aap Biomaterials GmbH & Co. KG · 2013
  • K123081Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40 Model 01-0217; Bonos…Aap Biomaterials GmbH & Co. KG · 20131 recall
  • K121876Vertecem II Cement KitAap Biomaterials GmbH · 2012
  • K090460Bonos InjectAap Biomaterials GmbH · 2009

All 2 as Aap Biomaterials GmbH & Co. KG →All 2 as Aap Biomaterials GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123081Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number…Oct 21, 2022Class II