PJN · Class II · 21 CFR 882.5330

FDA Product Code PJN: Filler, Bone Void, Non-alterable Compound For Cranioplasty

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 Nonalterable Cranial Bone Void Fillers Are Not Resorbable And Cannot Be Altered Or Reshaped At The Time Of Surgery Or After Implantation Without Changing The Chemical Behavior Of The Material.

Leading manufacturers include Ossdsign AB.

2
Total
2
Cleared
140d
Avg days
2019
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Filler, Bone Void, Non-alterable Compound For Cranioplasty Devices (Product Code PJN)

2 devices
1–2 of 2
Cleared Oct 01, 2021
OSSDSIGN Cranial PSI
K212414
Ossdsign AB
Neurology · 59d

About Product Code PJN - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PJN since 2019, with 2 receiving FDA clearance (average review time: 140 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

PJN devices are reviewed by the Neurology panel. Browse all Neurology devices →