# MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

- Device class: 2; regulation: 21 CFR 888.3080; FDA's rule: 510(k) required
- FDA decisions: 903
- 510(k) review time 2021–2025: median 94 days (middle half 57–160)
- Recalls: 50 (1 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: 76
- 2018: 64
- 2019: 60
- 2020: 56
- 2021: 53
- 2022: 41
- 2023: 30
- 2024: 38
- 2025: 29
- 2026: 18

## Most-cited predicates
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws (1999), cited by 99
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System (2001), cited by 54
- K071795: Nuvasive Coroent System (2007), cited by 42
- K073291: Capstone Spinal System (2008), cited by 41
- K071724: Lucent (2007), cited by 39
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation (1996), cited by 38
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems (2009), cited by 36
- P950002: Bak Interbody Fusion System (1996), cited by 35
- K090064: Eminent Spine Interbody Fusion System (2009), cited by 34
- K102293: Caliber Spacer (2011), cited by 31

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