# K180064: OsteoFab Patient Specific Cranial Device

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Performance Materials, Inc.
- Decided: Jul 27, 2018 after 199 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: 7 generations back to K904111 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121818: Osteofab Patient Specific Cranial Device, Oxford Performance Materials (2013) Summary page 4.

## Indications for use
The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.

Source page: https://510kreport.com/device/K180064
Methodology: https://510kreport.com/methodology