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Expedium Spine System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092626

by Depuy Spine, Inc.

Identifiers

510(k) Number
K092626 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Expedium Spine System consists of various spinal implant components, including screws, rods, and connectors. These implants are used for noncervical pedicle and nonpedicle fixation to provide mechanical immobilization and stabilization of spinal segments to facilitate fusion.

This system is intended for use in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The device is subject to FDA 510(k) authorization under K092626.

Frequently asked questions

What is the primary clinical purpose of the Expedium Spine System?

This system is designed for noncervical pedicle and nonpedicle fixation. It provides mechanical immobilization and stabilization of spinal segments to facilitate fusion in skeletally mature patients suffering from acute or chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

What components are included in the Expedium Spine System?

The system consists of various spinal implant components, which include rods, screws, and connectors used to stabilize the spine during the fusion process.

What is the regulatory status of this device?

The Expedium Spine System is subject to FDA 510(k) authorization under K092626. The device was determined to be substantially equivalent to existing systems through the special clearance process.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFICATION TO: EXPEDIUM SPINE SYSTEM - Innolitics, MODIFICATION TO EXPEDIUM SPINE SYSTEM - Innolitics, K080313 - MODIFICATION TO EXPEDIUM SPINE SYSTEM | FDA 510(k), PDF Spine_Expedium_5.5_Surgical_Technique_DF17-20-001.pdf

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA 510(k) K092626 24 fields · synced Sep 25, 2026