Englewood Cliffs, NJ., — GLW Foot & Ankle (Carbon22), a GLW Medical Innovation company (GLW) with a focus on the foot and ankle orthopedic market, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its upcoming Apollo Ankle Fracture (AFX) Plating System, a novel portfolio of see-through, “ortholucent” bone plates and screws used for orthopedic ankle fracture surgery. Expected to be in limited market release during the second half of 2022, it will complement GLW’s Creed Ortholucent Implant portfolio of headless and headed compression screws and it further expands GLW’s product offering in the foot and ankle space.
The Apollo AFX plating system is a streamlined, multi-component platform featuring a distinctive, proprietary plate composite consisting of an additive manufactured titanium shell injection molded with a novel Solvay Zeniva® PEEK polymer. The intelligently designed implants come with a selection of 26 unique plate options from 6 plate families.
Thomas H. Lee, MD, Chief Medical Officer of Carbon22, said “This next-generation engineering of Apollo AFX plates is an important milestone for our company. Our team has spent a tremendous amount of effort with our Carbon22 consortium, a select group of orthopedic and podiatric surgeons, to develop a system that includes several groundbreaking components; all working together to make ankle plating simpler and more reproducible. The Apollo AFX Plating System will be an important platform as we continue to develop our product portfolio. GW has created a bridge between materials science and device design, positively transforming the manufacturing process and cost-effectiveness, while maintaining, or improving patient outcomes.”
GLW’s patent pending ortholucent manufacturing technology offers several key benefits, including radio-transparency. Alan Ng, DPM, FACFAS of Advanced Orthopedic & Sports Medicine Specialists in Denver, CO noted, “While using medical imaging (both during and after surgery), the radio-translucent properties of these ankle fracture plates greatly improve visualization of bony structures. By being able to see through the implants down to the fracture site, these plates can vastly improve visibility during post-operative healing.”
The hybrid TI-PEEK plate interface minimizes the risk of plate and screw ”cold-welding” that has been seen with other plating systems currently on the market. Additionally, the hybrid TI-PEEK construction of the plates allow for superior contouring to accommodate complex anatomy.
“The Apollo AFX plating system represents a paradigm shift in orthopedic device implants and provides a distinguishing clinical advantage over traditional metal-only-implants by drastically improving intraoperative and postoperative visualization of bones and joint spaces,” commented Kevin Lutta, MD, of OrthoVirginia in Arlington, VA. Adding “The system’s well-designed details give surgeons the most advanced implant technology on the market to date.”
About GLW Medical Innovation
GLW is a medical technology company that uses its proprietary ortholucent technology platform to develop, additive manufacture, and sell orthopedic extremity and trauma implants and instruments. GLW owns issued patents and pending patent applications that cover hybrid materials and cost-effective manufacturing.