Identifiers
- 510(k) Number
- K162236 FDA 510(k)
- FDA Product Code
- OVD 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 Ax Stand-Alone ALIF System is an intervertebral body fusion device composed of Hydroxyapatite infused PEEK and a titanium face plate. It is designed for use in patients with degenerative disc disease at one or two contiguous levels of the lumbar spine (L2-S1). The device is available in multiple footprints and lordotic options, including a 30 degree hyperlordotic option.
The system is intended for anterior interbody fusion procedures and is supplied as a standalone device. It is designed for single use and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with the product code OVD and is classified under the orthopedic advisory committee.
Frequently asked questions
What is the Ax Stand-Alone ALIF System used for?
The Ax Stand-Alone ALIF System is designed for anterior interbody fusion procedures in patients with degenerative disc disease at one or two contiguous levels of the lumbar spine (L2-S1). It helps stabilize and fuse the vertebrae to alleviate pain and improve spinal function.
What materials is the Ax Stand-Alone ALIF System made from?
The device is composed of Hydroxyapatite infused PEEK (polyetheretherketone) with a titanium face plate. This combination provides both structural support and promotes bone integration for successful fusion.
Is the Ax Stand-Alone ALIF System reusable?
No, the Ax Stand-Alone ALIF System is designed for single use only. It should not be reused on multiple patients as this could compromise sterility and device integrity, potentially leading to surgical complications.
What size options are available for the Ax Stand-Alone ALIF System?
The system is available in multiple footprints and lordotic options to accommodate different patient anatomies. This includes a 30 degree hyperlordotic option, allowing surgeons to choose the most appropriate configuration for each patient's specific spinal condition.
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: AX - STAND ALONE ALIF - AxHA — Innovasis, PDF Stand-Alone ALIF System - SPINEMarketGroup, Ax Stand-Alone ALIF System - SPINEMarketGroup
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162236 | Class II | Active |
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Manufacturer
- Manufacturer
- Innovasis, Inc.
Sources (1)
- FDA 510(k) K162236 24 fields · synced Sep 25, 2026