# MQV: Filler, Bone Void, Calcium Compound

- Device class: 2; regulation: 21 CFR 888.3045; FDA's rule: 510(k) required
- FDA decisions: 493
- 510(k) review time 2021–2025: median 67 days (middle half 43–156)
- Recalls: 68 (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)
- 2017: 17
- 2018: 23
- 2019: 13
- 2020: 15
- 2021: 8
- 2022: 9
- 2023: 21
- 2024: 28
- 2025: 14
- 2026: 5

## Most-cited predicates
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler (2000), cited by 26
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute (1999), cited by 18
- K032288: Vitoss Scaffold Foam Bone Graft Material (2003), cited by 17
- K140375: Mastergraft Putty, Mastergraft Strip (2014), cited by 17
- K060728: Novabone Putty - Bioactive Synthetic Graft (2006), cited by 14
- K080009: Novabone Putty- Bioactive Synthetic Graft (2008), cited by 13
- K040262: DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix (2005), cited by 13
- K021336: Novabone-Resorbable Bone Graft Substitute (2002), cited by 13
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute (2007), cited by 12
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L (1998), cited by 11

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