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Genesys Spine AIS-C Cervical Stand-Alone System

by Genesys Spine

510(k) K181295

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 · Traditional NumberK181295 Date29 Aug 2018ClearedStatusActive

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  • Withdrawn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)

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

Overview

AI-generated summary, 20 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 AIS-C Cervical Stand-Alone System is a stand-alone interbody device designed for cervical spine surgery. It is a non-screw-based, zero-profile system intended for direct anterior access, providing bony fusion and fixation without traditional screw fixation.

This system is supplied as a sterile, single-use device and is intended for use in spinal surgical procedures. It includes a 3D-printed interbody cage with titanium anchors, incorporating Genesys Spine’s proprietary Semafour® Technology. The device holds an FDA 510(k) clearance under the Orthopedic advisory committee and is classified under product code OVE.

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Questions

AI-generated answers, 20 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 makes the Genesys Spine AIS-C Cervical Stand-Alone System different from traditional cervical spine fixation devices that use screws?

    The Genesys Spine AIS-C Cervical Stand-Alone System is designed without screws, offering a zero-profile interbody cage with titanium anchors instead. This non-screw-based approach provides bony fusion and fixation through direct anterior access, which may reduce the complexity of surgical placement compared to traditional screw-based systems.

  • Is the Genesys Spine AIS-C Cervical Stand-Alone System reusable, or is it intended for single-use only?

    The Genesys Spine AIS-C Cervical Stand-Alone System is explicitly supplied as a sterile, single-use device. This ensures patient safety and reduces the risk of cross-contamination, which is critical in surgical settings where sterility is paramount.

  • What proprietary technology does the Genesys Spine AIS-C Cervical Stand-Alone System incorporate, and how might it benefit spinal surgery?

    The system incorporates Genesys Spine’s proprietary Semafour® Technology, integrated into the 3D-printed interbody cage. This technology is designed to enhance bony fusion and stability, potentially improving outcomes for patients undergoing cervical spine surgery by promoting better integration with the surrounding bone.

  • How is the Genesys Spine AIS-C Cervical Stand-Alone System regulated in the U.S., and what does that mean for its use in surgery?

    The device holds FDA 510(k) clearance under the Orthopedic advisory committee, classified under product code OVE. This means it has been determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed and used in spinal surgical procedures as intended.