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Kyocera Medical Technologies, Inc. FDA Approvals

0 new drug approvals and 12 device clearances on file. Matched by name to KYOCF.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System510(k)Jul 15, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 15, 2026
Initia T3 Acetabular Hemispherical Shell System510(k)Apr 10, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 10, 2025
Tesera-k SC System510(k)Apr 10, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 10, 2025
Tesera-k PL System and Tesera-k XL System510(k)Mar 20, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 20, 2025
Initia Knee System510(k)Jan 13, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 13, 2025
Skyway Anterior Cervical Plate System510(k)Nov 5, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 5, 2024
TRIBRID® Unicompartmental Knee System510(k)Apr 4, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 4, 2024
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System510(k)Apr 21, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 21, 2023
Tesera-K SC System510(k)Dec 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 22, 2022
Tesera-k ALIF System510(k)Jan 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 7, 2022
KMTI S141 Lumbar Interbody Fusion System510(k)Aug 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 30, 2021
KMTI Hip Replacement System510(k)Apr 2, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 2, 2021

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