# KYI: Prosthesis, Wrist, Carpal Trapezium

- Device class: 2; regulation: 21 CFR 888.3770; FDA's rule: 510(k) required
- FDA decisions: 26
- Recalls: 4 (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)
- 1997: 5
- 2003: 1
- 2004: 3
- 2005: 1
- 2006: 3
- 2007: 2
- 2009: 1
- 2011: 2
- 2018: 1
- 2020: 1

## Most-cited predicates
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (2006), cited by 4
- K042690: Ascension Pyrosphere (PCS) (2004), cited by 3
- K041451: Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 (2004), cited by 3
- K864488: Swanson Titanium Condylar Implant (1987), cited by 3
- K960659: Ceramic Spherical CMC Implant (Subject to Marketing Approval) (1997), cited by 3
- K033529: Tie-in Trapezium (2003), cited by 2
- K040070: Artelon Spacer CMC-1 (2004), cited by 2
- K052596: Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 (2005), cited by 1
- K781756: Silastic H.P. Trapexial Implant (1978), cited by 1
- K964381: Avanta Orthopaedics Trapezial Implant (1997), cited by 1

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