# K053199: Synthes Patient Specific Cranial/Craniofacial Implant

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Dec 14, 2005 after 28 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: 1 generation back to K832283 (1984). 2 ancestors in all.
34 later devices descend from it; 11 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants, Synthes (Usa) (2004) Summary page 1.
- K832283: Medpar Surgical Implants, Porex Medical (1984) Summary page 1.

## Most influential descendants
- K062570: Patient Contoured Mesh (PCM) (2006), 17 descendants of its own
- K121153: Peek Customized Craial Implant Kit (2012), 13 descendants of its own
- K072707: Patient Contoured Mesh-Peek (PCM-P) (2007), 13 descendants of its own
- K103582: Kelyniam Custom Skull Implant (Csi) (2011), 8 descendants of its own
- K121755: Custom Craniofacial Implant (Cci) (2012), 5 descendants of its own

## Indications for use
Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Source page: https://510kreport.com/device/K053199
Methodology: https://510kreport.com/methodology