# K121153: Peek Customized Craial Implant Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Sep 14, 2012 after 151 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- 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). 10 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 3.
- K111065: Stryker (R) Patient Specific Polymer Implant, Howmedica Osteonics Corp. Dba Stryker Orthopeadics (2011) Summary page 3.

## Most influential descendants
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), 4 descendants of its own
- K132519: Stryker Customized Mandible Recon Plate Kit (2013), 3 descendants of its own
- K153248: PEEK Customized Cranial Implant (2016), 2 descendants of its own
- K261058: CraniUS Plate (2026), 1 descendant of its own
- K193136: Stryker Customized Mandible Recon Plate Kit (2020), 1 descendant of its own

## Indications for use
The PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.

Source page: https://510kreport.com/device/K121153
Methodology: https://510kreport.com/methodology