KYI — Prosthesis, Wrist, Carpal Trapezium Class II

FDA Device Classification

Classification Details

Product Code
KYI
Device Class
Class II
Regulation Number
888.3770
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201072ensemble orthopedicsEnsemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161December 2, 2020
K180744skeletal dynamicsStablyx CMC Arthroplasty Implant SystemApril 11, 2018
K111068skeletal dynamicsSTABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5December 30, 2011
K112278ascension orthopedicASCENSION NUGRIP CMC IMPLANTNovember 4, 2011
K092548extremity medicalEXTREMITY MEDICAL TRAPEZIUM PROSTHESISDecember 15, 2009
K061956artimplantARTELON STT SPACERJune 7, 2007
K061954artimplantARTELON CMC SPACER ARTHROJune 1, 2007
K061451ascension orthopedicsASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40August 11, 2006
K061089bioproMODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1June 20, 2006
K060386nexa orthopedicsNEXA CARPO METACARPAL IMPLANTMay 10, 2006
K052596bioproMODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17November 15, 2005
K042690ascension orthopedicsASCENSION PYROSPHERE (PCS)November 13, 2004
K040070artimplantARTELON SPACER CMC-1September 21, 2004
K041451ascension orthopedicsASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40,August 25, 2004
K033529wrightmedicaltechnologyincTIE-IN TRAPEZIUMDecember 3, 2003
K965204avanta orthopaedicsAVANTA ORTHOPAEDICS TRAPEZIUM IMPLANTJune 3, 1997
K960659wrightmedicaltechnologyincCERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)February 6, 1997
K960534wrightmedicaltechnologyincMETALLIC SPHERICAL CMC IMPLANTFebruary 6, 1997
K964472biologically oriented prosthesesRIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTFebruary 3, 1997
K964381avanta orthopaedicsAVANTA ORTHOPAEDICS TRAPEZIAL IMPLANTJanuary 22, 1997