# NPM: Bone Grafting Material, Animal Source

- Device class: 2; regulation: 21 CFR 872.3930; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 162 days (middle half 101–234)
- 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)
- 2015: 4
- 2016: 1
- 2017: 5
- 2018: 2
- 2020: 3
- 2021: 2
- 2023: 2
- 2024: 3
- 2025: 3
- 2026: 3

## Most-cited predicates
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen (2004), cited by 18
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic (2013), cited by 10
- K043034: Osteoguide Anorganic Bone Mineral Products (2005), cited by 9
- K092428: Bio-Oss Collagen (2010), cited by 4
- K112572: Geistlich Combi-Kit Collegen (2011), cited by 3
- K140714: Porcine Anorganic Bone Mineral (2014), cited by 3
- K112575: Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio (2011), cited by 2
- K240661: Geistlich Bio-Oss® (2024), cited by 2
- K142040: Ocs-B Collagen (2015), cited by 2
- K173188: The Graft Natural Bone Substitute (2018), cited by 1

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