KYIClass II

Prosthesis, Wrist, Carpal Trapezium

21 CFR 888.3770 / Orthopedic

KYI is the FDA product code for Prosthesis, Wrist, Carpal Trapezium, a class II device type, regulated under 21 CFR 888.3770. As of 2026-09-10, FDA records hold 26 510(k) clearances under this code, the most recent dated 2020-12-02, and 5 recalls.

Classification record

Product code: KYI
Device name: Prosthesis, Wrist, Carpal Trapezium
Regulation: 21 CFR 888.3770
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 26
Ingested recalls: 5

Clearances, product code KYI

By decision year

26 clearances under product code KYI with a decision year between 1978 and 2020, 1997 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code KYI by decision year
Year	Clearances
1978	1
1979	1
1980	1
1987	2
1995	1
1997	5
2003	1
2004	3
2005	1
2006	3
2007	2
2009	1
2011	2
2018	1
2020	1

Applicants with the most clearances

Product code KYI

Applicants holding the most 510(k) clearances under product code KYI
Applicant	Clearances
Wrightmedicaltechnologyinc	4
Artimplant AB	3
Ascension Orthopedics, Inc.	3
Avanta Orthopaedics, Inc.	2
Biopro, Inc.	2
Dow Corning Wright	2
Skeletal Dynamics, Inc	2
Ascension Orthopedic	1
B.H. Richardson, D.C.	1
Biologically Oriented Prostheses	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order