# K161090: Cranial PSI

- Pathway: 510(k) (Traditional)
- Applicant: Ossdsign AB
- Decided: Jan 19, 2017 after 276 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- 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: 4 generations back to K904111 (1990). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062570: Patient Contoured Mesh (PCM), KLS-Martin L.P. (2006) Summary page 4.

## Most influential descendants
- K212414: OSSDSIGN Cranial PSI (2021), 0 descendants of its own
- 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 (2019), 0 descendants of its own

## Indications for use
OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is 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/K161090
Methodology: https://510kreport.com/methodology