FDA product code · Neurology

Filler, Bone Void, Alterable Compound For Cranioplasty

Name: FDA decisions, review times, recalls and adverse event reports for product code PJM
Creator: 510(k) Report

PJMClass II21 CFR 882.5320510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of 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 device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or…

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 PJM 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 · PJM

FDA has decided no PJM device since 2007.

Median 510(k) review, days · PJM

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

Recalls per year · PJM

No recall names PJM since 2007.

Adverse event reports per year · PJM

1in 2020

2007high 1 (2020) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	1
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in PJM? 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

Related product codes

Other codes under 21 CFR 882.5320.

GWO Plate, Cranioplasty, Preformed, Alterable