510(k) Report

FDA applicant

Osteosymbionics, LLC

Cleveland, OH4 decisions2007–20140 recalls

FDA records 4 decisions for Osteosymbionics, LLC (Cleveland, OH) from 2007 to 2014: 4 510(k) clearances. Most are in product codes GXN (Plate, Cranioplasty, Preformed, Non-Alterable) and GXP (Methyl Methacrylate For Cranioplasty). Its devices cite 9 predicates, 2 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, neurology panel, where it files most

How often FDA has decided Osteosymbionics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12011: 12012: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Osteosymbionics, LLC’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?

  • GXNPlate, Cranioplasty, Preformed, Non-Alterable2decisions
  • GXPMethyl Methacrylate For Cranioplasty1decision
  • MNFImplant, Temporal1decision

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 20076cite it
  • K133082Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC · 20141cites it
  • K121102Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC · 20121cites it

What has FDA decided for it lately?

  • K133082Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC · 2014
  • K121102Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC · 2012
  • K111069Osteosymbionics, ST Temporalis ImplantOsteosymbionics, LLC · 2011
  • K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007

All 4 as Osteosymbionics, LLC →