# MBJ: Fastener, Fixation, Biodegradable, Hard Tissue

- Device class: 3; regulation: 21 CFR —; FDA's rule: Pathway set case by case
- FDA decisions: 1
- Recalls: 0 (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)
- 1993: 1

## Most-cited predicates
- K920188: Threaded Pins (1993), cited by 1

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