Varion Thoracolumbar Fixation System

FDA 510(k) K260989 · Kyocera Medical Technologies Inc. (KMTI)

Substantially Equivalent

510(k) numberK260989

Submission

Device name
Varion Thoracolumbar Fixation System
Applicant
Kyocera Medical Technologies Inc. (KMTI)
Redlands, CA, US
Received
March 25, 2026
Decision date
May 15, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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K253802KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special S.M.A.I.O07/01/2026SE
K253045“Socko” Vimax Spinal Fixation SystemNKB · Traditional Socko Medical Co., Ltd.06/17/2026SE
K251251ChanPin Pedicle Screw Spinal SystemNKB · Traditional Chanpin Medtak Co., Ltd.06/09/2026SE
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional Globus Medical, Inc.05/07/2026SE
K261130AccelFix Spinal Fixation SystemNKB · Special L&K BIOMED Co., Ltd.05/05/2026SE
K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional Spineart SA05/01/2026SE

More from Spineart SA

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K250486Skyway Anterior Cervical Plate SystemKWQ · Special 04/10/2025SE
K231766Skyway Anterior Cervical Plate SystemKWQ · Traditional 09/12/2023SE

Questions and answers

When was Varion Thoracolumbar Fixation System cleared by the FDA?

Varion Thoracolumbar Fixation System (K260989) received a 510(k) decision of Substantially Equivalent on May 15, 2026, 51 days after the submission was received.

What is the product code of K260989?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.