Cleared Traditional

Primus Spinal Fixation System

K243916 · Spinal Elements, Inc. · Orthopedic

Feb 2025

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K243916 is an FDA 510(k) clearance for the Primus Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 21, 2025, 63 days after receiving the submission on December 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K243916 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	February 21, 2025
Days to Decision	63 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.