Innosys has achieved a major milestone with US FDA 510(k) approval for its cutting-edge 3D printed cervical surgical cage, the “UniSpace Stand-Alone C Cage.” This innovative device is designed to replace damaged discs in spinal fusion surgery, promoting bone fusion through a biocompatible titanium structure that closely mimics human bone.
The UniSpace cage boasts a screw-integrated design, eliminating the need for a separate cervical plate. This advancement not only reduces surgery time but also minimizes incision sites, significantly enhancing patient recovery. To ensure the screws stay secure, the cage employs a dual-locking mechanism, featuring an automatic elastic band lock and a secondary locking plate for added fixation strength.
One of the standout features of UniSpace is its customization. Thanks to the flexibility of 3D printing, Innosys can produce the cage in 107 different sizes to meet individual patient needs based on factors like gender and skeletal size. This level of personalization leads to better surgical outcomes compared to traditional machined products. Moreover, the design enhances the structure's strength while preventing the titanium from damaging surrounding bone tissue.
With FDA approval in hand, Innosys is set to launch UniSpace in Korea, the US, and Chile starting in August, with plans for further expansion into Central and South America and Asia. Innosys CEO Ju Mi Chung highlighted the collaborative effort behind the product, saying, “UniSpace was designed in partnership with local doctors to ensure optimized treatment. Utilizing 3D printing technology, we've created a low-density structure ideal for bone fusion and implemented an automatic screw locking mechanism for quicker, more effective treatment outcomes.”
The FDA approval not only validates UniSpace’s innovative design but also positions Innosys for preferential treatment in global markets, boosting their export opportunities across North America, Central and South America, Oceania, and beyond.
Source: Innosys