Aurora Spine Gains FDA 510(k) Clearance for APOLLO Anterior Cervical Plate

By Julie A. Vetalice

Aurora Spine Gains FDA 510(k) Clearance for APOLLO Anterior Cervical Plate

Aurora Spine received FDA 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP). It features a 1.9mm design with Hyper-Angulation™ variability in the Cephalad-Caudal screw angulation of 32°, offering Freedom to Angulate™.

The new ACP system I s designed to help reduce common postoperative complications such as dysphagia, malalignment and adjacent level ossification. This is supported by:

  • Freedom to Angulate, including Hyper-Angulation screw variability, to optimize performance for each surgical level to support construct stability.
  • Implant length options to match a variety of patient anatomies and facilitate maximizing the distance from the adjacent levels; and
  • Advanced screw offerings with fixed and variable angles to enable better screw placement and locking accuracy.

APOLLO is part of the DEXA™ family of products that are positioned to reshape the market through patent focused innovation.

Trent Northcutt, President and CEO, said, “This approval is an important piece to the puzzle for advancing Aurora Spine’s key initiative of bringing more proprietary-based products to the marketplace and decreasing our reliance on third-party products. Sales of cervical plates in fiscal 2019 represented approximately 10% of revenues for Aurora and the APOLLO plate will enable Aurora to convert another portion of the company’s revenue base into a proprietary product and allow us to capture higher margins. This new product will also support sales of our TiNANO™ cervical cages and enable us to develop additional products around our DEXA™ patent, which matches implants to a patient’s bone density.”

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory