# GWO: Plate, Cranioplasty, Preformed, Alterable

- Device class: 2; regulation: 21 CFR 882.5320; FDA's rule: 510(k) required
- FDA decisions: 44
- 510(k) review time 2021–2025: median 278 days (middle half 195–337)
- Recalls: 3 (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)
- 2015: 3
- 2016: 3
- 2017: 2
- 2018: 1
- 2019: 4
- 2021: 1
- 2022: 2
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K121153: Peek Customized Craial Implant Kit (2012), cited by 4
- K112812: Leforte Neuro System Bone Plate (2012), cited by 4
- K112557: Stryker Universal Neuro 3 System (2012), cited by 4
- K141911: Optimus Neuro System (2015), cited by 3
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), cited by 3
- K120352: Stryker Quikflap Sterile Procedure Pack (2012), cited by 2
- K141452: Leforte Neuro System Bone Plate and Screw (2014), cited by 2
- K161821: Stryker Universal Mesh (2016), cited by 2
- K123723: Synthes Matrixneuro Cranial Plating System (2013), cited by 2
- K111065: Stryker (R) Patient Specific Polymer Implant (2011), cited by 2

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