Varion Thoracolumbar Fixation System— 510(k) K260989

Name: FDA 510(k) clearance K260989
Creator: U.S. Food and Drug Administration
Published: 2026-05-15

Substantially Equivalent

Kyocera Medical Technologies Inc. (KMTI)

FDA 510(k) clearance K260989 for Varion Thoracolumbar Fixation System, Substantially Equivalent on 2026-05-15. Applicant: Kyocera Medical Technologies Inc. (KMTI). Device class: 2.

Summary

Kyocera Medical Technologies (KMTI) filed the Varion Thoracolumbar Fixation System under NKB, thoracolumbosacral pedicle screw systems.

Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Kyocera filed from Redlands, California. The decision came 51 calendar days after receipt (March 25 to May 15, 2026).

Clearance details

Applicant: Kyocera Medical Technologies Inc. (KMTI)
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2026-03-25
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

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K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
K252139 — Kentrospine Viktr-MIS® Pedicle screw system2026-09-27

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Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.