# GXP: Methyl Methacrylate For Cranioplasty

- Device class: 2; regulation: 21 CFR 882.5300; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 161 days (middle half 154–172)
- Recalls: 5 (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)
- 2006: 4
- 2007: 3
- 2009: 1
- 2010: 1
- 2015: 1
- 2017: 1
- 2019: 1
- 2023: 2
- 2024: 2
- 2026: 4

## Most-cited predicates
- K873689: Cranioplastic, Acrylic Cranioplasty Material (1987), cited by 10
- K072601: Osteosymbionics Patient Specific Cranial Implant (2007), cited by 6
- K043334: Bone Source Hac Rapid Setting Cement (2005), cited by 5
- K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler (1999), cited by 5
- K060763: Stryker Injectable Cement (2006), cited by 5
- K012589: Fast Set Putty (2002), cited by 4
- K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC (1998), cited by 4
- K953339: Bonesource Hydroxyapatite Cement (Hac) (1996), cited by 4
- K964537: Bonesource Hydroxyapatite Cement (Hac) (1997), cited by 3
- K021440: Bonesource Hac (2002), cited by 3

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