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Primus Spinal Fixation System

by Spinal Elements, Inc. 510(k)

Active United States

510(k) K243916

Overview

The Primus Spinal Fixation System is a minimally invasive modular screw system designed for spinal fixation procedures. It provides versatility and efficiency through adaptability in a compact, modular format with a vast array of implants engineered to work efficiently with intuitive instrumentation.

This system may be used in conjunction with the Spinal Elements Overwatch System and can be connected to Lotus Posterior Cervical/Thoracic rod connectors to achieve additional levels of fixation. The device is supplied as a modular system with various implant options and is authorized under FDA 510K clearance with product code NKB.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243916 Date21 Feb 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Primus Spinal Fixation System used for?

    The Primus Spinal Fixation System is a minimally invasive modular screw system designed for spinal fixation procedures. It provides versatility and efficiency through adaptability in a compact, modular format with various implant options.

  • How is the Primus Spinal Fixation System supplied?

    The device is supplied as a modular system with various implant options engineered to work efficiently with intuitive instrumentation. It may be used in conjunction with the Spinal Elements Overwatch System and Lotus Posterior Cervical/Thoracic rod connectors.

  • What is the regulatory status of the Primus Spinal Fixation System?

    The Primus Spinal Fixation System is authorized under FDA 510K clearance with product code NKB. It received traditional clearance with a decision code of SESE (Substantially Equivalent) on 2025-02-21.

  • Can the Primus Spinal Fixation System be used with other systems?

    Yes, the system may be used in conjunction with the Spinal Elements Overwatch System and can be connected to Lotus Posterior Cervical/Thoracic rod connectors to achieve additional levels of fixation.