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Spinal Jaxx Interbody Fusion Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152501

by Neuropro Spinaljaxx, Inc.

Identifiers

510(k) Number
K152501 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 Spinal Jaxx Interbody Fusion Device is a hollow, porous, threaded and/or fenestrated cylindrical or geometrical interbody fusion device made of titanium endplates that contact the vertebral bodies. It is designed for use in spinal fusion surgeries and allows surgeons to customize the implant to the specific anatomy of the patient through its wide-ranging expansion capability, enabling small implants to be inserted and expanded to adequately fill the interbody space.

The device is supplied with proprietary instrumentation that allows the surgeon to effectively fill the implant with autograft after implantation and set the implant to the desired position. It is authorized under FDA 510(k) clearance (K152501) with product code MAX and was determined to be substantially equivalent to a predicate device. The device is intended for use in orthopedic spinal fusion procedures as reviewed by the Orthopedic advisory committee.

Frequently asked questions

What is the Spinal Jaxx Interbody Fusion Device used for?

The Spinal Jaxx Interbody Fusion Device is designed for use in spinal fusion surgeries, specifically orthopedic spinal fusion procedures, where it is implanted between vertebral bodies to promote bone growth and stabilize the spine. Its expandable design allows surgeons to customize the fit to the patient's anatomy after insertion, ensuring adequate filling of the interbody space for optimal fusion conditions.

How is the Spinal Jaxx Interbody Fusion Device supplied and implanted?

The device is supplied with proprietary instrumentation that enables surgeons to insert the implant in a compact state, then expand it intraoperatively to fill the interbody space. After implantation, the same instrumentation allows the surgeon to fill the hollow, porous device with autograft bone material and set it to the desired position, facilitating biological fusion through direct bone contact with the titanium endplates.

Is the Spinal Jaxx Interbody Fusion Device reusable or single-use?

The Spinal Jaxx Interbody Fusion Device is intended for single-use only. As an implantable medical device designed for permanent implantation in spinal fusion surgery, it is not designed to be removed, reprocessed, or reused. Reuse would compromise structural integrity, sterility, and patient safety, and is not supported by its design, materials, or regulatory authorization under FDA 510(k) K152501.

What materials is the Spinal Jaxx Interbody Fusion Device made of, and what are its key structural features?

The device is made of titanium endplates that contact the vertebral bodies and features a hollow, porous, threaded and/or fenestrated cylindrical or geometrical structure. This design allows for bone ingrowth through the porous surface, provides mechanical stability via threading or fenestrations, and enables the implant to be expanded after insertion to match the patient's interbody space dimensions, all while maintaining biocompatibility and load-bearing capacity.

What regulatory pathway was used for the Spinal Jaxx Interbody Fusion Device?

The Spinal Jaxx Interbody Fusion Device received authorization through the FDA 510(k) premarket notification pathway, specifically under clearance K152501. It was determined to be substantially equivalent to a predicate device, with product code MAX, and its submission was reviewed by the Orthopedic advisory committee. This pathway confirms the device's safety and effectiveness for its intended use in spinal fusion procedures based on comparison to legally marketed devices.

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: Spinal Jaxx - Creators of the Expandable Spinal Implant, Spinal Jaxx - thespinemarketgroup.com, DEVICE: Spinal Jaxx Interbody Fusion Device (00818956020153)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neuropro Spinaljaxx, Inc.

Sources (1)

  • FDA 510(k) K152501 24 fields · synced Sep 21, 2026