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Calix Lumbar Spinal Implant System

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

Active United States

510(k) K131350

Overview

The Calix Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine. The implants are generally hollow box or oval-shaped devices that have an array of holes throughout their geometry. Superior and inferior surfaces of the device have teeth to help prevent implant dislodgement or expulsion once placed in its desired location.

The device is supplied non-sterile and intended for single-use. It is indicated for use in the lumbar spine and has received FDA 510(k) clearance under product code MAX, with K-number K131350. The device is manufactured by X-Spine Systems, Inc. and is not MRI conditional unless explicitly stated in labeling.

AI-generated from registry data, 26 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 NumberK131350 Date23 Oct 2013ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0127-2017 FDA Class II initiated 17 May 2016
    • Terminated Z-0125-2017 FDA Class II initiated 17 May 2016
    • Terminated Z-0126-2017 FDA Class II initiated 17 May 2016
    • Terminated Z-0124-2017 FDA Class II initiated 17 May 2016

    The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.

Specification

510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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