FDA Panel to Consider Reclassifying Spinal Spheres

The FDA’s orthopedic expert panel will meet on December 12, 2013 to make recommendation regarding the classification of spinal sphere devices.

The devices are currently regulated under the heading of “Intervertebral Fusion Device with Bone Graft, Solid-Sphere, Lumbar”, Product Code NVR, as unclassified devices and reviewed under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness of spinal sphere devices and the regulatory classification for spinal sphere devices.

Since 2005, four manufacturers submitted 510(k) applications to clear their devices. They included Medtronic, Inc.’s Satellite Spinal System, Biomet Spine’s Spinal Stabilization Sphere System, Interbody Innovation LLP’s Spinal Spheres and PEEK Spinal Spheres and Life Spine’s Spinal Sphere System.

These devices are spheres manufactured from metallic (e.g., cobalt chromium molybdenum) or polymeric (e.g., polyetheretherketone) materials. According to the FDA, they are intended to be inserted between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft for holding bone parts in alignment while they heal. These devices are not intended for use in motion-sparing, non-fusion procedures.

The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet for two days at the Hilton Washington D.C. North, in Gaithersburg, Maryland. On December 13, the panel will consider reclassifying stair climbing wheelchairs from Class III to Class II.

To read the FDA announcement and participation details, click here.