# LYC: Bone Grafting Material, Synthetic

- Device class: 2; regulation: 21 CFR 872.3930; FDA's rule: 510(k) required
- FDA decisions: 231
- 510(k) review time 2021–2025: median 298 days (middle half 267–456)
- Recalls: 10 (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)
- 2010: 13
- 2011: 9
- 2012: 5
- 2013: 2
- 2014: 1
- 2016: 2
- 2020: 3
- 2022: 2
- 2025: 3
- 2026: 3

## Most-cited predicates
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio (2005), cited by 17
- K051885: MBCP (2005), cited by 14
- K974399: Bio-Oss Collagen (1998), cited by 12
- K970321: Bio-Oss Anorganic Bovine Bone (1998), cited by 12
- K040278: Perioglas-Bioglass Bone Graft Substitute (2004), cited by 12
- K992416: Perioglas- Bioglass Bone Graft Particulate (1999), cited by 10
- K000149: Novabone-Bioglass Bone Graft Particulate (2000), cited by 8
- K930115: Perioglass (1993), cited by 7
- K962494: Perioglas - Bioglass Bone Graft Particulate (1996), cited by 7
- K003286: Symphony Graft Delivery System (2001), cited by 7

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