# K190523: Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

- Pathway: 510(k) (Traditional)
- Applicant: Ossdsign AB
- Decided: Oct 10, 2019 after 220 days
- Product code: PJN (Filler, Bone Void, Non-Alterable Compound For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904111 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161090: Cranial PSI, Ossdsign AB (2017) Summary page 4.

## Indications for use
Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

Source page: https://510kreport.com/device/K190523
Methodology: https://510kreport.com/methodology