Product code KYI— Orthopedic
ARTELON CMC SPACER ARTHRO
- Classification name
- Prosthesis, Wrist, Carpal Trapezium
- Device class
- Class 2
- Regulation
- 21 CFR 888.3770
- Advisory panel
- Orthopedic
- Total cleared
- 26
- First cleared
- Most recent
Market context for product code KYI
FDA has cleared devices under product code KYI between 1978 and 2020, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2018
- 2011
- 2009
- 2007
- 2006
- 2005
- 2004
- 2003
- 1997
- 1995
- 1987
- 1980
- 1979
- 1978
Top applicants under product code KYI
Recent clearances under product code KYI
- K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
- K180744 — Stablyx CMC Arthroplasty Implant System
- K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
- K112278 — ASCENSION NUGRIP CMC IMPLANT
- K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
- K061956 — ARTELON STT SPACER
- K061954 — ARTELON CMC SPACER ARTHRO
- K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
- K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
- K060386 — NEXA CARPO METACARPAL IMPLANT
- K052596 — MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
- K042690 — ASCENSION PYROSPHERE (PCS)
- K040070 — ARTELON SPACER CMC-1
- K041451 — ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
- K033529 — TIE-IN TRAPEZIUM
- K965204 — AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
- K960534 — METALLIC SPHERICAL CMC IMPLANT
- K960659 — CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
- K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
- K964381 — AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
- K951471 — STRICKLAND TRAPEZIAL IMPLANT
- K864488 — SWANSON TITANIUM CONDYLAR IMPLANT
- K864489 — SWANSON TITANIUM TRAPEZIUM IMPLANT
- K801952 — SPINE ALIGN
- K790508 — TRAPEZIO-METACARPAL JOINT SPACER
- K781756 — SILASTIC H.P. TRAPEXIAL IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.