AIS-C Stand Alone System by Genesys Spine

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DESIGN DETAILS
DESIGN NAME:
AIS-C

PRIMARY FUNCTION:
Stand Alone System

INSPIRATION:
The Genesys Spine team set-out to try to create the first ever direct-anterior Anchored Interbody System that could be visually confirmed and revised.

UNIQUE PROPERTIES / PROJECT DESCRIPTION:
There are very few non-screw based Cervical Stand-Alone systems because they are often difficult to effectively revise compared to screws which can simply be unthreaded. The Genesys Spine Cervical Stand-Alone System enables surgeons to utilize a direct anterior approach which allows for a smaller, mid-line incision. The system utilizes a quick, simple, non-impacting Anchor insertion method that does not need an awl or drill. No extra steps are required to lock the Anchors into position and the locking mechanism provides visual confirmation of engagement, but allows for Anchor removal when desired.

OPERATION / FLOW / INTERACTION:
Cervical spine fusions require stabilization of the joint to allow complete fusion to occur. Traditional cervical spine fusions required an interbody to be coupled with a cervical plate to limit motion and provide stability. With the Genesys AIS-C Cervical Stand-Alone System, the fixation was incorporated into the interbody which can eliminate the need for a cervical plate or other forms of supplemental fixation.

PROJECT DURATION AND LOCATION:
The project was initiated in July of 2014 at the Genesys Spine Headquarters in Austin, TX.

FITS BEST INTO CATEGORY:
Scientific Instruments, Medical Devices and Research Equipment Design

PRODUCTION / REALIZATION TECHNOLOGY:
Conceptualized in Solid works, 3D printed for functional testing and physician review, then fine-tuned using ANSYS mechanical Finite Element Analysis. Once the geometry was selected, design verification parts were manufactured and tested according to ASTM standard test methods.

SPECIFICATIONS / TECHNICAL PROPERTIES:
The Genesys Spine AIS C Cervical Stand-Alone System is offered in two footprints: Small (14mm X 12mm) and Large (17mm X 14mm). The offered interbody heights range from 5mm - 12mm. There are three available configurations to conform to varying patient anatomies: Parallel, Lordotic, and Convex.

TAGS:
Stand-Alone, Non-screw-based fixation, Cervical, Anchored, Interbody, Genesys Spine, Direct Anterior, Zero-Step Locking Mechanism, Cervical Fusion System, Anchored Interbody

RESEARCH ABSTRACT:
Genesys Spine initiates all new projects by conducting research in three main areas: 1) Perform a review of white papers pertinent to the field of interest. 2) Conduct a MAUDE database review and research complaints as well as any other available post-market surveillance. 3) Present our findings to surgeons and clinicians to gain feedback. Design surgeons are formally selected based on their surgical repertoire and experience and work with our team on final outputs.

CHALLENGE:
The hardest part of this design and project was developing a locking mechanism that did not require any additional steps to deploy, would allow the Anchors to pass by during initial system deployment, would not allow the Anchors to back-out prematurely, yet could be easily removed or revised by the surgeon. Balancing each of these requirements was a long iterative process that required significant engineering analysis and surgeon interaction. In the end, the Genesys Spine team was able to produce a system that is expected to lead the industry for years to come.

ADDED DATE:
2018-07-02 16:01:59

TEAM MEMBERS (1) :
Lead Designer: Landon Gilkey, Project Leader: Benjamin Keller, Lead Quality Manager: William Sowers. Additional Team Members: Brian Bergeron, Francois Follini, and Chloe Lance

IMAGE CREDITS:
J. Landon Gilkey

PATENTS/COPYRIGHTS:
Patent Application number: 15/605334 http://www.freepatentsonline.com/y2017/0340453.htm l

Visit the following page to learn more: https://www.genesysspine.com/
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CLIENT/STUDIO/BRAND DETAILS
NAME:
Genesys Spine

PROFILE:
Genesys Spine is a growing medical device company based in Austin, TX. Their products, including proprietary features and system-specific instruments, have garnered positive feedback from the marketplace and support their mission of providing surgeons a product that excels in the competitive and crowded landscape while reducing surgical time and effort. For more information, please visit www.genesysspine.com

NOMINATION DETAILS

Ais-C Stand Alone System by Genesys Spine is a Nominee in Scientific Instruments, Medical Devices and Research Equipment Design Category.

· This project is currently confidential as results have not been announced yet. Images and further details of the project is not available for public yet, please check back later. If you are the owner of this design, please login to view the images.

· The profile and other works by Genesys Spine is also kept secret. This information will also be available later.
AWARD DETAILS

Ais-C Stand Alone System by Genesys Spine is Winner in Scientific Instruments, Medical Devices and Research Equipment Design Category, 2018 - 2019.

· Read the interview with designer Genesys Spine for design AIS-C here.

· Press Members: Login or Register to request an exclusive interview with Genesys Spine.

· Click here to view the profile and other works by Genesys Spine.
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