# K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 21, 2004 after 192 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
No predicates in its family tree.
44 later devices descend from it; 7 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Porex Medical: MEDPOR Porous Polyethylene Cranial Implants: named in the summary without a submission number

## Most influential descendants
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant (2005), 34 descendants of its own
- K072601: Osteosymbionics Patient Specific Cranial Implant (2007), 20 descendants of its own
- K052871: Stryker Custom TI Implant (2005), 18 descendants of its own
- K062570: Patient Contoured Mesh (PCM) (2006), 17 descendants of its own
- K121153: Peek Customized Craial Implant Kit (2012), 13 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/K033868
Methodology: https://510kreport.com/methodology