# KWD: Prosthesis, Toe, Hemi-, Phalangeal

- Device class: 2; regulation: 21 CFR 888.3730; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 56 days (middle half 53–357)
- Recalls: 14 (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)
- 2013: 2
- 2016: 1
- 2017: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant (2004), cited by 9
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System) (2002), cited by 7
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 (2004), cited by 7
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation (2007), cited by 7
- K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 (2004), cited by 6
- K971047: Futura Biomedical Metal Hemi Toe Implant (1997), cited by 6
- K911378: Townley Great Toe Joint (1991), cited by 5
- K102401: Hemi Implant; Mini Hemi Implant (2011), cited by 4
- K131377: Hemicap MTP Resurfacing Hemi-Arthroplasty Implant (2013), cited by 3
- K073065: Osteomed Metatarsal Resurfacing Implant System (2008), cited by 3

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