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Genesys Spine Anterior Cervical Plate System

by Genesys Spine

510(k) K111132

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK111132 Date9 Dec 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0921-2013 FDA Class II initiated 20 Feb 2013

    Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Genesys Spine Anterior Cervical Plate System is an orthopedic device classified as an Anterior Cervical Plate (Device Type: KWQ). It is designed for internal spinal fixation in the cervical spine, providing rigid stabilization to promote proper alignment and fusion of vertebrae. The system incorporates a binary locking mechanism to enhance screw retention and resistance to rotational forces, ensuring secure fixation during the healing process.

This system is supplied as a reusable surgical implant and is intended for use in operating room settings. It includes self-drilling, self-tapping screws in two diameters—3.75mm for primary fixation and 4.25mm for recovery—available in fixed and variable configurations. The screws feature a star drive and color-coding for easy identification. The device holds FDA 510(k) clearance (K111132) under the Orthopedic advisory committee and is regulated as a Class II medical device.

Other devices from Genesys Spine

See all devices from Genesys Spine →

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of screws are included in the Genesys Spine Anterior Cervical Plate System and how are they distinguished?

    The system includes self-drilling, self-tapping screws in two diameters: 3.75mm for primary fixation and 4.25mm for recovery. They are designed with a star drive for compatibility and feature color-coding to allow easy identification during surgery.

  • Is the Genesys Spine Anterior Cervical Plate System intended for single-use or can it be reused?

    The device is explicitly described as a reusable surgical implant, meaning it is intended for use in multiple procedures after proper cleaning and sterilization between cases.

  • What specific cervical spine stabilization does this plate system provide, and how does its locking mechanism work?

    The Genesys Spine Anterior Cervical Plate System provides rigid stabilization to promote proper alignment and fusion of cervical vertebrae. It incorporates a binary locking mechanism, which enhances screw retention and resistance to rotational forces, ensuring secure fixation during the healing process.

  • What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

    The device received FDA clearance through a Traditional 510(k) pathway under the Orthopedic Advisory Committee (OR) and is classified as a Class II medical device. The clearance number is K111132, and it was determined to be substantially equivalent to a predicate device.