Cleared Traditional

Tesera-k PL System and Tesera-k XL System

K242771 · Kyocera Medical Technologies, Inc. · Orthopedic

Mar 2025

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K242771 is an FDA 510(k) clearance for the Tesera-k PL System and Tesera-k XL System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on March 20, 2025, 188 days after receiving the submission on September 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242771 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2024
Decision Date	March 20, 2025
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.