# KWH: Prosthesis, Toe, Constrained, Polymer

- Device class: 2; regulation: 21 CFR 888.3720; FDA's rule: 510(k) required
- FDA decisions: 21
- Recalls: 2 (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)
- 1995: 2
- 1998: 1
- 2000: 1
- 2002: 4
- 2003: 1
- 2011: 1
- 2016: 1
- 2018: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K022886: Metatarsophalangeal Flexible Stabilizing Rod System (2002), cited by 2
- K946236: Profix Conforming Plus Tibial Insert (1995), cited by 2
- K981194: Futura Biomedical Flexible Great Toe Implant (1998), cited by 2
- K153609: RTS Flexible 1 MPJ Implant w/Grommets (2016), cited by 2
- K022887: Interphalangeal Flexible Stabilizing Rod System (2002), cited by 1
- K884739: Sgarlato Lesser Toe Implant (1989), cited by 1
- K905795: Sgarlato Flexible Hinge Toe Implant (1991), cited by 1
- K023531: Lesser Metatarsal Phalangeal Joint Implant (2003), cited by 1
- K801094: Silastic Hammertoe Implant (Swanson-Well (1980), cited by 1
- K823405: Zimmer Great Toe (1983), cited by 1

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