# K121755: Custom Craniofacial Implant (Cci)

- Pathway: 510(k) (Traditional)
- Applicant: Kelyniam Global, Inc.
- Decided: Sep 25, 2012 after 102 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). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 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 2.
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 2.
- K072707: Patient Contoured Mesh-Peek (PCM-P), KLS-Martin L.P. (2007) Summary page 2.
- K110684: Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant, Vanduzen Dba Medcad (2011) Summary page 2.

## Most influential descendants
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), 4 descendants of its own
- 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 Kelyniam Customized Craniofacial Implant (CCI) is intended to correct bony voids in the Craniofacial skeleton.

Source page: https://510kreport.com/device/K121755
Methodology: https://510kreport.com/methodology