# MTJ: Wax, Bone

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 107 days (middle half 42–548)
- Recalls: 2 (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)
- 2013: 2
- 2014: 4
- 2015: 2
- 2016: 2
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 4
- 2026: 2

## Most-cited predicates
- K971680: Auto Suture Bone Wax (1997), cited by 8
- K041363: Aoc Bone Wax (2004), cited by 7
- K043260: Orthocon LLC Orthostat Hemostatic Bone Putty (2005), cited by 7
- K024372: CP Medical Bone Wax (2003), cited by 6
- K791495: Lukens Bone Wax (Gamma Radiation) (1979), cited by 5
- K152005: MONTAGE Settable, Resorbable Hemostatic Bone Putty (2015), cited by 5
- K082491: Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene (2008), cited by 4
- K141502: HBP4 Hardening, Resorbable Hemostatic Bone Putty (2014), cited by 4
- K102762: Orthostat Bone Hemostat Matrix Applicator (2011), cited by 4
- K123243: Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty (2013), cited by 3

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