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Depuy Spine Lateral Cage System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082128

by Depuy Spine

Identifiers

510(k) Number
K082128 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Depuy Spine Lateral Cage System is an intervertebral body fusion device used in lateral spine procedures to treat degenerative disc disease in the thoracolumbar region (T1-L5). It is designed to provide controlled access and simplified cage insertion as part of a lateral approach system. The system is intended for use in conjunction with posterior fixation options to support spinal stability and fusion.

The device is supplied as a system of implants and instrumentation for single-patient use, typically in a sterile surgical setting. It is manufactured by Depuy Spine and authorized under FDA 510(k) clearance (K082128) as substantially equivalent to existing devices. The system is designed for lateral placement and is compatible with the MIS Lateral Platform System, which includes the COUGAR LS Lateral Cage System and INSIGHT LS Lateral Access System.

Frequently asked questions

What types of spinal procedures is the Depuy Spine Lateral Cage System designed for, and why is it specifically suited for a lateral approach?

The Depuy Spine Lateral Cage System is designed for lateral spine procedures to address degenerative disc disease in the thoracolumbar region (T1-L5). It is specifically suited for a lateral approach because it provides controlled access and simplifies cage insertion through this pathway, which is often used to avoid disrupting posterior musculature and reduce postoperative pain compared to traditional anterior or posterior approaches.

Is the Depuy Spine Lateral Cage System intended for single-use or can it be reused? How is it typically supplied?

The Depuy Spine Lateral Cage System is supplied for single-patient use, as indicated by its design for sterile surgical settings. This ensures patient safety and sterility, which is critical in spinal fusion procedures where infection control is paramount.

What other systems is the Depuy Spine Lateral Cage System compatible with, and how does this compatibility benefit the surgeon?

The Depuy Spine Lateral Cage System is compatible with the MIS Lateral Platform System, which includes the COUGAR LS Lateral Cage System and INSIGHT LS Lateral Access System. This compatibility allows surgeons to integrate the cage system seamlessly with other components of the lateral approach, streamlining the procedure and enhancing spinal stability through posterior fixation options.

How is the regulatory status of this device determined, and what does the FDA 510(k) clearance indicate about its safety and effectiveness?

The Depuy Spine Lateral Cage System holds an FDA 510(k) clearance (K082128) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) to existing devices. This clearance indicates that the device meets regulatory standards for safety and effectiveness by demonstrating it is not substantially different from legally marketed predicate devices, ensuring it complies with FDA requirements for spinal fusion implants.

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: MIS Lateral Platform System | Lateral Access | DePuy Synthes, Spine | DePuy Synthes, DePuy Synthes adds spine implants with Expanding Innovations buy

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Depuy Spine

Sources (1)

  • FDA 510(k) K082128 24 fields · synced Sep 19, 2026