# MBI: Fastener, Fixation, Nondegradable, Soft Tissue

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 606
- 510(k) review time 2021–2025: median 58 days (middle half 29–121)
- Recalls: 76 (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: 16
- 2019: 31
- 2020: 35
- 2021: 18
- 2022: 19
- 2023: 52
- 2024: 22
- 2025: 27
- 2026: 30

## Most-cited predicates
- K071586: Bioraptor 2.3 PK Suture Anchor (2007), cited by 23
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), cited by 17
- K083070: Toggleloc System (2008), cited by 11
- K083635: Smith & Nephew Biosure PK Interference Screw (2009), cited by 11
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor (2010), cited by 10
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor (2011), cited by 10
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an (2012), cited by 9
- K972326: Peba Anchor/Suture Combination (1998), cited by 9
- K133671: Iconix All Suture Anchors (2014), cited by 8
- K953877: Mitek Gii Anchor (1995), cited by 8

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