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Apache Lateral Lumbar Interbody Fusion System

by Genesys Spine

510(k) K130913

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK130913 Date13 Dec 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Genesys Spine Apache Lateral Lumbar Interbody Fusion System
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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Apache Lateral Lumbar Interbody Fusion System is a spinal implant designed for intervertebral body fusion in the lumbar spine, spanning levels L2 to S1. Classified as an orthopedic device, it facilitates structural support and stabilization by promoting bony fusion between adjacent vertebrae. This system is intended for use in skeletally mature patients with degenerative disc disease, including those with up to Grade 1 spinal stenosis or degenerative spondylolisthesis. The device is engineered to restore spinal alignment and reduce pain associated with degenerative conditions.

The system is supplied as a sterile, single-use device and is intended for surgical implantation via a lateral approach. It is regulated under FDA 510(k) clearance (K130913) as substantially equivalent to a predicate device, with approval for use at one or two contiguous lumbar levels. Sterility is maintained through manufacturer-controlled processes, and the device must be stored according to the provided instructions to preserve integrity. Compliance with FDA guidelines ensures its safety and performance for spinal fusion procedures.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Apache Lateral Lumbar Interbody Fusion System used for?

    This system is designed for intervertebral body fusion in the lumbar spine (levels L2 to S1) to treat degenerative disc disease, including cases with up to Grade 1 spinal stenosis or degenerative spondylolisthesis. It provides structural support, restores spinal alignment, and reduces pain by promoting bony fusion between adjacent vertebrae.

  • How is the Apache Lateral Lumbar Fusion System supplied and sterilized?

    The device is supplied as a sterile, single-use system. Sterility is maintained through manufacturer-controlled processes, ensuring it is ready for immediate surgical use without additional sterilization by the clinician.

  • Can this system be reused, or is it intended for single-use only?

    The Apache Lateral Lumbar Fusion System is explicitly designed for single-use only. Reuse is not recommended or supported, as it could compromise sterility, structural integrity, and clinical performance.

  • What levels of the lumbar spine does this system address?

    This system is approved for use at one or two contiguous lumbar levels, specifically spanning L2 through S1. It is not intended for use above L2 or below S1.

  • How should the Apache Lateral Lumbar Fusion System be stored?

    To preserve sterility and integrity, the device must be stored according to the manufacturer’s provided instructions. Improper storage could lead to contamination or damage, affecting its performance during surgery.