# K212414: OSSDSIGN Cranial PSI

- Pathway: 510(k) (Traditional)
- Applicant: Ossdsign AB
- Decided: Oct 1, 2021 after 59 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
OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

Source page: https://510kreport.com/device/K212414
Methodology: https://510kreport.com/methodology