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Axle Interspinous Fusion System

by X-Spine Systems, Inc. 510(k)

Active United States

510(k) K101471

Overview

The Axle Interspinous Fusion System is an implantable device designed to be attached to two adjacent vertebral spinous processes. It provides immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions such as degenerative disc disease, spinal tumors, and trauma.

This system is used for rigid posterior fixation and offers multiple configurations to tailor the implant to patient anatomy, including options for L5-S1 engagement. The device is implanted via a tissue-sparing approach as an alternative to pedicle screws. This system has received FDA 510k clearance.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101471 Date24 Nov 2010ClearedStatusActive

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

1 recall · FDA

    • Terminated Z-0034-2012 FDA Unclassified (pre-2012) initiated 15 Jul 2011 via K101471, on the same 510(k)

    The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical purpose of the Axle Interspinous Fusion System?

    This system is designed to provide immobilization and stabilization of spinal segments. It serves as an adjunct to bony fusion for patients suffering from conditions including degenerative disc disease, spinal tumors, and trauma.

  • How is the Axle system implanted compared to traditional methods?

    The device is implanted using a tissue-sparing approach. This method is intended to serve as an alternative to the use of pedicle screws for posterior fixation.

  • Can the Axle Interspinous Fusion System be customized for different patients?

    Yes, the system offers multiple configurations to tailor the implant to specific patient anatomy. This includes specific options for L5-S1 engagement to ensure proper fit during the fusion procedure.

  • What is the regulatory status of this device?

    The Axle Interspinous Fusion System has received FDA 510k clearance under K101471. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.