510(k) Report

FDA applicant

Ossdsign AB

Uppsala, SE6 decisions2014–20230 recalls

FDA records 6 decisions for Ossdsign AB (Uppsala, SE) from 2014 to 2023: 6 510(k) clearances. Most are in product codes PJN (Filler, Bone Void, Non-Alterable Compound For…) and GXR (Cover, Burr Hole). Its devices cite 7 predicates, 3 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 Ossdsign AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12017: 12018: 12019: 12021: 12023: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Ossdsign AB by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2decisions
  • GXRCover, Burr Hole2decisions
  • MQVFiller, Bone Void, Calcium Compound1decision
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K232315Catalyst Bone Void FillerOssdsign AB · 20234cite it
  • K161090Cranial PSIOssdsign AB · 20172cite it
  • K140309CranioplugOssdsign AB · 20141cites it
  • K181539OSSDSIGN CranioplugOssdsign AB · 20181cites it

What has FDA decided for it lately?

  • K232315Catalyst Bone Void FillerOssdsign AB · 2023
  • K212414OSSDSIGN Cranial PSIOssdsign AB · 2021
  • K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified…Ossdsign AB · 2019
  • K181539OSSDSIGN CranioplugOssdsign AB · 2018
  • K161090Cranial PSIOssdsign AB · 2017
  • K140309CranioplugOssdsign AB · 2014

All 6 as Ossdsign AB →