# K121818: Osteofab Patient Specific Cranial Device

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Performance Materials
- Decided: Feb 7, 2013 after 232 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: 6 generations back to K904111 (1990). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103582: Kelyniam Custom Skull Implant (Csi), Kelyniam Global, Inc. (2011) Summary page 1.
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 5.
- K072601: Osteosymbionics Patient Specific Cranial Implant, Osteosymbionics, LLC (2007) Summary page 1.
- K110684: Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant, Vanduzen Dba Medcad (2011) Summary page 1.
- K121102: Osteosymbionics Peek Cranial Implant, Osteosymbionics, LLC (2012). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K180064: OsteoFab Patient Specific Cranial Device (2018), 0 descendants of its own

## Indications for use
The OsteoFab™ Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton.

Source page: https://510kreport.com/device/K121818
Methodology: https://510kreport.com/methodology