# MAI: Fastener, Fixation, Biodegradable, Soft Tissue

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 221
- 510(k) review time 2021–2025: median 60 days (middle half 30–143)
- Recalls: 61 (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: 9
- 2018: 13
- 2019: 9
- 2020: 9
- 2021: 8
- 2022: 6
- 2023: 8
- 2024: 7
- 2025: 8
- 2026: 5

## Most-cited predicates
- K101679: Arthrex Pushlock Anchors (2010), cited by 21
- K051219: Pushlock (2005), cited by 14
- K101823: Arthrex Swivelock Anchors (2011), cited by 14
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew (2009), cited by 13
- K062466: Arthrex Interference Screw (2006), cited by 13
- K203495: Arthrex SwiveLock Anchor (2021), cited by 11
- K073412: Gryphon BR and Healix BR Anchors (2008), cited by 10
- K140855: Arthrex Suturetak Suture Anchors (2014), cited by 10
- K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System (1997), cited by 9
- K003227: Bio-Absorbable Corkscrew Model AR-1920B (2001), cited by 8

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