510(k) Report

FDA product code · Neurology

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

PJNClass II21 CFR 882.5330510(k) required2 decisions since 20190 recalls

2 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 59 days (half between 59 and 59). No recall names this code.

A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of PJN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PJN

1in 2021

2019: 12021: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PJN

Too few PJN 510(k)s in any year since 2007 to give a median.

Recalls per year · PJN

No recall names PJN since 2007.

Adverse event reports per year · PJN

1in 2025

2023: 22025: 1
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code PJN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20211—00
20220—00
20230—02
20240—00
20250—01
20260—0—
FIG. 1 — PJN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PJN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which PJN devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K212414OSSDSIGN Cranial PSIOssdsign AB · 20215generations
  • K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified…Ossdsign AB · 20195generations

What has FDA decided in PJN lately?

  • K212414OSSDSIGN Cranial PSIOssdsign AB · 2021
  • K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified…Ossdsign AB · 2019

All 2 PJN decisions →

Related product codes

Other codes under 21 CFR 882.5330.

GXN Plate, Cranioplasty, Preformed, Non-AlterablePBJ Cranial Distraction System