FDA Clears Novel Intervertebral Body Fixation Orthosis

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a standalone lateral lumbar interbody fusion device from the internationally renowned surgeon Randal Betz, M.D.’s company, Foundation Surgical.

The device, is intended for use in “patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L1-S1).” According to the 510(k) summary document, DDD is “defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.” Patients should be “skeletally mature and have had at least six (6) months of non-operative treatment” and may have “up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).”

According to the FDA, the device is “to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone, and is to be used with the two titanium alloy screws which accompany the implant.” Additionally, if a physician makes the decision to use less than the two screws, “additional supplemental fixation must be used to augment stability.”

In order to qualify for the shorter and earlier 510(k) clearance the device must be substantially equivalent to a predicate device. Here, the predicate devices include the following: F3D Lateral Lumbar Interbody System and Oro Plate by CoreLink, LLC; PIVOX™ Oblique Lateral Spine System by Medtronic Sofamor Danek USA, Inc.; and NuVasive CoRoent Thoracolumbar System by NuVasive, Inc. According to the 510(k) summary document, the subject and predicate devices have nearly identical technological characteristics.

Foundation Surgical, a spine implant company, submitted the device for 510(k) clearance. The device is its Interwedge^® Standalone Lateral Interbody System.

The device is used in conjunction with Foundation Surgical’s LLIF180™ procedure. According to the company, the LLIF180 is the “first bilateral-fixated standalone-lateral procedure performed through a single-position lateral or oblique-lateral lumbar spine approach.”

Foundation Surgical Founder Randal Betz, M.D. said, “The FDA clearance of the Interwedge^® system represents a significant step forward for lateral lumbar spine surgery and implant technology.”

Dr. Betz continued, “We believe the novelty of the LLIF180™ procedure and unique features of the Interwedge^® system, like the bilateral fixation via the deployable staple, offer surgeons enhanced options for standalone lateral interbody spinal stabilization.”

Dr. Betz was Chief of Staff and Medical Director of the Spinal Cord Injury Program at Shriners Hospitals for Children, Philadelphia. He is Professor of Orthopaedic Surgery at Temple University School of Medicine. In 2013, Dr. Betz served as the senior mentor for the Scoliosis Research Society Traveling Fellowship.

Among his many accomplishments, Dr. Betz:

• Has been issued ten U.S. patents for new methods and treatments for scoliosis
• Authored over 300 peer-reviewed articles and 45 chapters in medical textbooks
• Performed over 900 presentations, invited lectures and distinguished lectureships worldwide
• Was co-editor of four medical textbooks on spine surgery and one medical textbook on pediatric spinal cord injury

Dr. Betz is an active member of the Scoliosis Research Society (for which he served as President in 2005), the American Academy of Orthopaedic Surgeons, American Paraplegia Society, American Spinal Injury Association, and the Pediatric Orthopaedic Society of North America. Dr. Betz is a recipient of the A. Estin Comarr Memorial Award for Clinical Service from the American Paraplegia Society, and the Lifetime Achievement Award from the American Spinal Injury Association.