# GXN: Plate, Cranioplasty, Preformed, Non-Alterable

- Device class: 2; regulation: 21 CFR 882.5330; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 133 days (middle half 69–303)
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 2
- 2018: 3
- 2020: 5
- 2021: 3
- 2022: 2
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 4

## Most-cited predicates
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant (2005), cited by 11
- K972332: Aesculap Craniofix Titanium Clamp System (1998), cited by 8
- K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants (2004), cited by 7
- K991029: Rapidflap Cranial Clamp (1999), cited by 6
- K072707: Patient Contoured Mesh-Peek (PCM-P) (2007), cited by 5
- K991860: Synthes Cranial Flap Twist Clamp (1999), cited by 5
- K040864: Craniofix and CRANIOFIX2 Titanium Clamp System (2004), cited by 4
- K062570: Patient Contoured Mesh (PCM) (2006), cited by 4
- K013050: The Bioplate Zip Craniotomy Fixation System (2001), cited by 4
- K103582: Kelyniam Custom Skull Implant (Csi) (2011), cited by 4

Source page: https://510kreport.com/product-code/GXN
Data by year (CSV): https://510kreport.com/product-code/GXN.csv