Facet Dynamics, Inc.
“The Holy Grail of Spine”

What clinical problem in lumbar degeneration motivated development of the Restore device?

In the initial stages of development, Dr. Sturm was asked, “So, what is this thing? What is it supposed to do?”, after completing his presentation of “Restore”, a completely novel and innovative spinal device, to a group of spinal instrumentation company executives. The engineer in the audience chimed in, “It’s the ‘Holy Grail of Spine’, If you can get it to work…”

Well, Facet Dynamics, Inc. did just that, they “got it to work”…

Lumbar degenerative disease remains one of the most prevalent and costly conditions in modern healthcare. It consistently ranks among the top expenditures in U.S. healthcare spending, reflecting both its frequency and the enduring realities of human biomechanics.

As Dr. Chris D. Sturm, whose groundbreaking work in spinal surgery offers an innovative solution, “Restore”—the Emerging Lumbar Facet Joint Replacement Device—explains, lumbar degeneration is not a problem that will disappear. Human beings are upright organisms living under constant gravitational load. The motion segments of the spine—each composed of a disc and paired facet joints—are stacked in a configuration that allows movement to dissipate force. When that system deteriorates, pain and neurological compromise follow.

For nearly eighty years, lumbar fusion has been the primary surgical solution for many degenerative conditions requiring stabilization. Fusion achieves stability by eliminating motion at the affected level. Yet the spine was designed to move. Each motion segment contributes to a cascade of load distribution. When motion is arrested at one level, force is transferred to adjacent segments, accelerating degeneration in those regions. This phenomenon, commonly referred to as adjacent segment disease, is a well-recognized clinical reality. Many patients who undergo fusion ultimately require additional surgery above or below the original construct.

Public perception reflects this biomechanical tension. While fusion remains the standard of care in many situations, it carries a reputation for sacrificing natural motion. Artificial lumbar disc technology attempted to address this concern, but its primary contraindication—facet joint degeneration—limits eligibility for the overwhelming majority of surgical candidates.

According to Dr. Sturm, facet degeneration is present in approximately ninety-eight percent of patients who would otherwise qualify for disc replacement. As a result, the posterior facet joint has emerged as a critical driver of the projected $18.2 billion lumbar spine market by 2030, with roughly eighty-five percent of that market influenced by facet-related pathology.

Our device is designed to integrate seamlessly into existing procedures, using the same screws and instruments that surgeons are already familiar with.

Within this landscape, Facet Dynamics has developed an investigational unilateral lumbar facet joint replacement system designed to provide stability while preserving motion. The device is not yet approved for commercial use and remains in the regulatory and investigational phase. Its development has included bench testing, cadaveric evaluation, and structured consultation with the U.S. Food and Drug Administration. Regulatory clarity has been central to the company’s progression.

The Innovative Facet Joint Replacement Device

How does the Restore device replicate facet biomechanics while integrating with existing surgical instrumentation?

The design philosophy is rooted in biomechanics rather than market positioning. The device is intended to replicate the anatomy of the facet joint rather than override it. It connects to standard 5.5-millimeter rod-compatible pedicle screws—the same tulip polyaxial screws used in hundreds of thousands of lumbar fusions each year. Surgeons do not need to abandon their preferred instrumentation systems. The implant interfaces with existing screws in exactly the same way a rod would. There is no new platform, no elaborate training requirement, and no change to core workflow.

In cadaveric testing mandated by regulatory guidance, seven specimens underwent unilateral facet replacement. The results demonstrated reproduction of flexion and extension neutral-zone mechanics, which represent the primary modes of lumbar motion. Neutral-zone reproduction reached one hundred percent in testing, compared to twenty-five percent in comparative data from an existing bilateral posterior motion device. Even more significant from a biomechanical standpoint was force transmission at the screw–bone interface. The Facet Dynamics device demonstrated approximately forty percent less force compared to the TOPS device and sixty-seven percent less force compared to Dynasty flexible rod constructs. Reduced force at the screw–bone interface suggests a construct that works with spinal mechanics rather than imposing rigidity upon them.

Two guest surgeons, unfamiliar with the system and provided only brief orientation, were required by the FDA to implant the device during testing. Despite complex experimental conditions involving micro-wires and fluoroscopic guidance, they achieved implantation in an average of 17.5 minutes. They were not informed that they were being timed. Their specimens were included in the final biomechanical data. The implication is not speed alone but procedural familiarity. The device was engineered to minimize the opportunity for implantation error and to require placement in a neutral position to preserve both flexion and extension.

Allowing Patients to Regain Stability

How does unilateral facet replacement support motion preservation while treating degenerative pathology?

The unilateral design allows surgeons to replace only the degenerative anatomy without removing normal contralateral structures. By contrast, certain bilateral posterior motion systems require removal of all posterior anatomy at the operative level. Facet Dynamics’ approach is anatomically selective. Surgeons can address pathology on one side while preserving healthy tissue on the other. In cases of lateral disc herniation where significant facet removal may be necessary to decompress neural elements, the investigational device could theoretically allow full decompression without committing the patient to fusion. This aligns with a surgical philosophy many spine surgeons articulate: preserve motion when possible, minimize anatomical disruption, and avoid unnecessary rigidity.

The device is also engineered with minimally invasive surgery in mind. Its compact design permits compatibility with percutaneous screw systems and ambulatory surgical center workflows. Unlike larger systems that require extensive exposure, the implant connects directly to existing screw constructs, enabling a procedural sequence that mirrors standard rod placement. Potential integration with robotic guidance systems further reflects forward-looking surgical adaptability.

The Next Phase

What regulatory, clinical, and capital milestones define the next development phase?

Facet Dynamics has secured four U.S. patents, along with patents in Australia and Canada, as well as international coverage under the Patent Cooperation Treaty, protecting its intellectual property across multiple jurisdictions. The company has also entered into an agreement with a subsidiary of Water Street Capital to cover regulatory costs associated with required bench testing and clinical study preparation. A separate agreement with a spinal instrumentation company provides pedicle screw supply for investigational studies. Future plans include demonstrating equivalency with additional screw systems to broaden compatibility.

The next phase involves an Investigational Device Exemption (IDE) pivotal multicenter clinical trial. The anticipated design includes approximately three hundred patients, with half receiving the investigational device and half undergoing traditional fusion. All patients would be followed for two years, both radiographically and clinically, to assess safety and effectiveness.

Longer-term data collection is also planned, potentially extending to ten years or more, recognizing that implant longevity and adjacent segment behavior require time to evaluate. Bench testing requirements are estimated at approximately $600,000, while total capital needs to advance through regulatory milestones and IDE study execution are projected at approximately $30.82 million.

Material composition parallels that of established hip and knee arthroplasty systems. Given that facet joint load is substantially lower than load across weight-bearing joints such as the hip, anticipated implant longevity appears favorable in theory, though only longitudinal data will confirm durability. The reduced force transmission observed in testing supports expectations of mechanical longevity relative to earlier dynamic constructs.

Working with the Spine

Market access considerations are also pragmatic. Because the device attaches to standard pedicle screws and does not require surgeons to abandon contractual relationships with dominant instrumentation companies, adoption barriers may be lower than for systems requiring exclusive platform shifts. Additionally, prior regulatory clearance of posterior motion-preserving devices has established CPT coding and reimbursement pathways, easing future integration once approval is obtained.

Dr. Sturm is candid about the broader philosophical implications. Fusion, he acknowledges, remains necessary in many cases and continues to be performed daily. Yet when asked whether surgeons would prefer to maintain motion rather than eliminate it, the overwhelming majority would choose motion, all other factors being equal. The investigational device is designed to align with that instinct.

Facet Dynamics does not present its system as a wholesale replacement for fusion. Instead, it offers a biomechanically aligned alternative for selected patients in whom motion preservation may reduce long-term segmental stress. It reflects a design ethic centered on cooperation with anatomy rather than domination of it.

In spine surgery, the guiding oath remains clear: first, do no harm. Motion preserved, anatomy respected, and stability achieved without unnecessary rigidity define the philosophical endpoint. The work ahead involves clinical validation, regulatory execution, and disciplined data collection. If outcomes align with early biomechanical evidence, lumbar surgery may evolve from stability through elimination toward stability through preservation—working with the spine rather than overriding it.