# LZJ: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 1 (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)
- 1989: 1
- 1991: 1
- 1992: 1
- 1993: 2
- 1994: 2
- 1995: 1
- 2008: 1
- 2010: 1
- 2014: 1

## Most-cited predicates
- K924724: Kinetik Great Toe System (1994), cited by 2
- K072251: Merete Toemobile Anatomical Great Toe Resurfacing System (2008), cited by 2
- K132496: Arthrosurface Toemotion (2014), cited by 2
- K102549: The Ascension Movement Great Toe System Total Arthroplasty (2010), cited by 1
- K920446: Total Toe System (1993), cited by 1
- K922211: Osteomed Great Toe System (1993), cited by 1

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