US-based company Spinal Resources has received approval from the US Food and Drug Administration (FDA) for its Solutions Based Spine Platform (SBSP).
The new Bezier Rod platform will help surgeons treat critical spinal conditions such as Proximal Junctional Failure (PJF), Proximal Junctional Kyphosis (PJK) and Adjacent Segment Disease (ASD).
Spinal Resources founder, president and CEO Bernard Bedor said: “We are thrilled about the FDA-approval of our Solutions Based Spine Platform as it is a testament to our commitment to innovation and bringing spinal care forward.”
SBSP has a novel screw cap interface, which adjusts between a polyaxial and monoaxial head, enabling screw head manipulation, compression, distraction, and coronal de-rotation.
The system offers a range of Bezier Taper transition rods and curved Morphotypes developed from post-operative data with transitions between linear segments.
The Swedge pedicle Screw and Locking Cap system facilitates the use of the entire rod, including the tapered segments.
Furthermore, the system enables surgeons to use individual rod diameters based on bone quality.
The Bezier rod platform can be used across several disciplines due to the availability of shorter-length rods.
The Bezier Rod will provide a synergistic pathway between deformity and degenerative spinal forms.
The company is additionally engaged in the development of an artificial intelligence (AI) platform that is expected to have the potential to reduce the forces and loads on adjacent segments.
The platform will also offer insights to assess the performance of the rods, cap, and screw interface.