# K103582: Kelyniam Custom Skull Implant (Csi)

- Pathway: 510(k) (Traditional)
- Applicant: Kelyniam Global, Inc.
- Decided: Apr 14, 2011 after 127 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904111 (1990). 11 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 20 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 2.
- K072601: Osteosymbionics Patient Specific Cranial Implant, Osteosymbionics, LLC (2007) Summary page 2.
- K072707: Patient Contoured Mesh-Peek (PCM-P), KLS-Martin L.P. (2007) Summary page 2.

## Most influential descendants
- K121755: Custom Craniofacial Implant (Cci) (2012), 5 descendants of its own
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), 4 descendants of its own
- K261058: CraniUS Plate (2026), 1 descendant of its own
- K121818: Osteofab Patient Specific Cranial Device (2013), 1 descendant of its own
- K262874: CraniUS Plate (2026), 0 descendants of its own

## Recalls of this device
- Jun 10, 2017 · Class II · Z-1872-2018: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant
- Jun 10, 2017 · Class II · Z-1871-2018: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant
- Jun 10, 2017 · Class II · Z-1873-2018: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant
- Jun 10, 2017 · Class II · Z-1870-2018: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant

## Indications for use
Patient Specific Cranial implants are intended for the replacement of bony voids in the cranial skeleton.

Source page: https://510kreport.com/device/K103582
Methodology: https://510kreport.com/methodology