Cleared Traditional

Vulcan Spinal System

K253545 · K2m, Inc. · Orthopedic

Feb 2026

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K253545 is an FDA 510(k) clearance for the Vulcan Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on February 10, 2026, 88 days after receiving the submission on November 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K253545 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2025
Decision Date	February 10, 2026
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.