The design inspiration for the Binary® ACP System stemmed from the need for an implant with maximum screw articulation while maintaining a robust locking feature. The ability to articulate the screws is crucial in placing a cervical plate accurately. Insufficient articulation can lead to the plate being positioned higher on the cervical spine, increasing the risk of adjacent-level ossification. To address this challenge, the Binary® ACP System incorporates patented Helios Technology from Genesys Spine, which combines counter rotation functionality, anti-backout functionality, and the innovative "Zero-Step" feature.
The "Zero-Step" feature is a clever ratcheted screw-head system that locks into place in the head of the screws with a satisfying click. This unique locking mechanism ensures optimal placement of the plate and reduces the risk of complications. The Binary® ACP System offers plate sizes ranging from 1 level to 4 levels, with a smooth low-profile design that incorporates lordotic curvature to minimize plate contouring during the procedure.
One of the key strengths of the Binary® ACP System is its exceptional screw angulation capability without adding to the plate profile. This achievement was a significant technical challenge, as maintaining high articulation while keeping the plate thin is crucial to minimize clinical issues. By finding the perfect balance between required angulation and an integrated lock, the Binary® ACP System provides surgeons with a reliable and efficient solution for cervical spine stabilization.
The Binary® ACP System has undergone extensive research and testing to ensure its effectiveness and safety. The design team, led by J. Landon Gilkey, utilized Ultra-Elastic metal (Nitinol) for the unique locking mechanism. Nitinol offers elongation without deformation, exceptional strength, and biocompatibility. The plates underwent rigorous mechanical testing, including a 5 million cyclic load, to demonstrate their durability and long-term performance.
Surgeons and end users were involved in the evaluation process, providing valuable feedback on the ease of use and clinical effectiveness of the Binary® ACP System. The results were overwhelmingly positive, with the system removing guesswork for surgeons and reducing surgical time, anesthesia exposure, and the risk of complications for patients.
The Binary® ACP System was developed over a span of 14 months, from May 2013 to July 2014, in Austin, Texas. The design team, including inventors such as Josh Kaufmann and Scott Bryant, worked tirelessly to overcome technical challenges and create a truly innovative solution for cervical spine stabilization.
With its groundbreaking features and exceptional performance, the Binary® ACP System has garnered recognition in the design community. It was awarded the prestigious Iron A' Design Award in the Medical Devices and Medical Equipment Design category in 2016. This accolade is a testament to the Binary® ACP System's well-designed, practical, and innovative nature, meeting professional and industrial requirements while contributing to a better world.
The Binary® ACP System, with its revolutionary design and advanced technology, is revolutionizing cervical spine stabilization, improving surgical outcomes, and enhancing patient recovery. It is a testament to the ingenuity and dedication of J. Landon Gilkey and the design team at Genesys Spine.
Project Designers: Brian Bergeron
Image Credits: Brian Bergeron
Project Team Members: Inventors Names:
Josh Kaufmann
Scott Bryant
Greg Calbert
Brian Bergeron
Landon Gilkey
John Stokes, M.D.
Matthew Geck, M.D.
Engineers Names:
James “Landon” Gilkey
Benjamin Keller
Brian J. Bergeron
Project Name: Binary®
Project Client: Brian Bergeron