U.S. FDA Grants First-of-Its-Kind Designation to Camber Spine SPIRA-A

Camber Spine announced that it has received U.S. Food and Drug Administration 510(k) clearance for its SPIRA-A Integrated technology.

The SPIRA-A Integrated Fixation System is an anterior lumbar interbody fusion device featuring an open matrix design that allows for the use of autogenous/allogenous graft material to promote fusion. 

It also gives additional fixation options to ensure secure placement of the implant within the disc space. 510(k) clearance of SPIRA-A Integrated technology guides in the next evolution in SPIRA platform.

It helps to bring more innovation-based solutions and options to the surgical community and a solution for surgeons. SPIRA Technology, which integrates the structural design, surface engineering, and scientific advancements of 3D-printing process. 

It serves as a model for contemporary spine implants and highlights the key advantages of additive manufacturing.

The SPIRA-A Integrated system provides a comprehensive solution for Anterior Lumbar Interbody Fusion (ALIF) procedures. It features integrated fixation within a traditional ALIF cage design, enabling a familiar surgical approach.

Additionally, it includes a windswept cage geometry specifically designed for challenging L5-S1 cases with complex vascular anatomy. Each implant is engineered to maximize stability, offering up to 40 points of contact with the endplate.

The device is equipped with three openings for the insertion of bone screws or anchors, ensuring integrated fixation. It also includes blocking screws to prevent the fixation from backing out.

The screws and anchors in the SPIRA-A system are designed to enhance the performance of the cage, improving fixation at the cortical endplate. 

They feature innovative 3D-printed anchors with a SPIRA Surface, specifically designed to promote Bone fusion and resist pull-out forces.

SPIRA implants are 3D printed. This specialized manufacturing technology features open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth.

Source: https://www.businesswire.com/news/home/20240723159060/en/Camber-Spine-Receives-FDA-Clearance-for-SPIRA-A-Integrated-Fixation-System