# K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

- Pathway: 510(k) (Traditional)
- Applicant: Kelyniam Global, Inc.
- Decided: May 21, 2019 after 236 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: 7 generations back to K904111 (1990). 19 ancestors in all.
4 later devices descend from it; 3 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)
- K121153: Peek Customized Craial Implant Kit, Stryker (2012) Summary page 4.
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 4.
- K103582: Kelyniam Custom Skull Implant (Csi), Kelyniam Global, Inc. (2011) Summary page 4.
- K121755: Custom Craniofacial Implant (Cci), Kelyniam Global, Inc. (2012) Summary page 4.

## Most influential descendants
- K261058: CraniUS Plate (2026), 1 descendant of its own
- K262874: CraniUS Plate (2026), 0 descendants of its own
- K250334: Fusion Craniofacial Implant; Fusion Skull Implant (2025), 0 descendants of its own
- K231834: VSP PEEK Cranial Implant (2024), 0 descendants of its own

## Indications for use
The Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a patient’s specific cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone).

Source page: https://510kreport.com/device/K182711
Methodology: https://510kreport.com/methodology