# K121102: Osteosymbionics Peek Cranial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Osteosymbionics, LLC
- Decided: Aug 8, 2012 after 119 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: 3 generations back to K904111 (1990). 8 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K072601: Osteosymbionics Patient Specific Cranial Implant, Osteosymbionics, LLC (2007) Summary page 1.
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 1.
- K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- K121818: Osteofab Patient Specific Cranial Device (2013), 1 descendant of its own
- K180064: OsteoFab Patient Specific Cranial Device (2018), 0 descendants of its own

## Indications for use
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.

Source page: https://510kreport.com/device/K121102
Methodology: https://510kreport.com/methodology