Fixation devices play a critical role in spinal surgeries, ensuring stability and facilitating successful outcomes. The SPIRA-A Integrated device, recently cleared by the FDA, is indicated for use at one or more levels from L1-S1 in skeletally mature patients. Camber Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its SPIRA-A Integrated Fixation System, designed for anterior lumbar interbody fusion (ALIF) procedures.
The SPIRA-A Integrated, part of the SPIRA product platform, is an ALIF device featuring an open matrix design that facilitates the packing of autogenous and/or allogenous graft material to promote fusion. With the FDA’s clearance, the device is now indicated for use at one or more levels from L1-S1 in skeletally mature patients. It is suitable for treating various conditions, including degenerative disc disease (DDD), disc herniation with myelopathy and/or radiculopathy, deformity, spondylolisthesis, spinal stenosis, and failed previous fusion (pseudarthrosis).
Fixation: SPIRA-A Integrated Device Offers Comprehensive ALIF Solution with Enhanced Stability
The superior and inferior surfaces of the SPIRA-A Integrated device feature a rough texture, which helps improve stability.
Additionally, structural arches within the device distribute the load across the joint space effectively. The device is equipped with three holes for the insertion of bone screws or anchors, complemented by blocking screws to prevent fixation back out. The screws and anchors of the SPIRA-A system are designed to augment the performance of the cage and improve fixation in the cortical endplate. They are 3D-printed with a SPIRA Surface to enhance osseointegration and resist pull-out.
Fixation: SPIRA-A System Enhances Surgical Access with Robust Inserter and 3D-Printed Implants
The SPIRA-A system’s robust inserter attachment and multiple technique possibilities, along with a range of screw prep options, are intended to ensure clear visualization and easy access to the surgical site. Camber Spine’s SPIRA implants, including the SPIRA-A Integrated Fixation System, are manufactured using 3D printing technology, which allows for precise and customized production.
In 2020, Camber Spine launched the SPIRA-C Integrated Interbody System and the FORTICO Anterior Cervical Plating System, both of which also utilize advanced design and manufacturing techniques to improve surgical outcomes. The SPIRA-A Integrated Fixation System builds on this legacy, offering surgeons a versatile and effective tool for addressing complex spinal conditions.
The SPIRA-A Integrated device’s clearance by the FDA marks a significant advancement in the field of spinal surgery. By providing a reliable and adaptable solution for anterior lumbar interbody fusion, the device has the potential to improve patient outcomes and reduce the incidence of complications. The innovative design features, such as the windswept cage geometry and 3D-printed anchors, demonstrate Camber Spine’s commitment to advancing spinal surgery technology.
In conclusion, the FDA’s clearance of the SPIRA-A Integrated Fixation System represents a major milestone for Camber Spine and the broader field of spinal surgery. The device’s advanced features and comprehensive design offer a promising new option for treating a range of spinal conditions. As Camber Spine continues to innovate and expand its product offerings, patients and surgeons alike stand to benefit from improved surgical tools and techniques.
Resource: Business Wire, July 23, 2024
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