# MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

- Device class: 2; regulation: 21 CFR 888.3045; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 65 days (middle half 65–65)
- Recalls: 26 (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)
- 2005: 6
- 2006: 7
- 2007: 5
- 2008: 5
- 2009: 1
- 2011: 1
- 2012: 1
- 2013: 3
- 2015: 1
- 2024: 1

## Most-cited predicates
- K051195: Grafton DBM (2005), cited by 11
- K053098: Optium DBM Gel and Putty (2005), cited by 4
- K062205: DBX Strip (2007), cited by 4
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty (2012), cited by 4
- K050642: Orthoblast II Putty and Paste (2005), cited by 4
- K042829: DBX Strip (2006), cited by 4
- K080329: Cap Plus, Equivabone, Cap/DBM (2008), cited by 3
- K060794: Progenix DBM Putty and Paste (2006), cited by 3
- K080399: DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste (2008), cited by 2
- K050806: Optecure (2006), cited by 2

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