510(k) Clearance for VyPlate Anterior Cervical Plate System

Tallahassee, Florida-based VySpine™, LLC, a spinal instrumentation and implant company, has been granted FDA 510(k) clearance for its VyPlate Anterior Cervical Plate System.

VySpine’s VyPlate Anterior Cervical Plate System includes the following components: implant, instrument, and tray. Per the FDA, the implant components consist of “anterior cervical plates, cover plates, and bone screws” which are comprised of titanium alloy 6Al-4V as specified by ASTM F-136.

The VyPlate Anterior Cervical Plate System is indicated for “stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies.” The specific clinical indications for anterior plating include the following:

• “instability caused by trauma or fracture;
• instability associated with correction of cervical lordosis and kyphosis deformity;
• instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.”

The VyPlate Anterior Cervical Plate System “is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.”

According to the FDA 510(k) document, the device is “substantially equivalent to the primary predicate Reliance Anterior Cervical Plate System (K122216, K140742), in terms of material, intended use, levels of attachment, size range, and strength.”

OTW spoke with VySpine CEO Tom McLeer about the VyPlate system and he said, “We are excited to offer surgeons the VyPlate ACP System, which is the latest in a series of particularly versatile and cost-effective cervical products, with several more to follow by the end of this year.”