The InFill TLIF line and the InFill ALIF can both take advantage of The InFill Graft Delivery System.
Dallas, TX, May 6, 2014 – Pinnacle Spine Group has announced the FDA 510(k) clearance of two new InFill TLIF interbody devices, the Convex Oblique and the Contour Oblique models. These two additions complement the InFill Lordotic TLIF product offering, giving surgeons a range of options to choose from depending on surgeon preference, the vertebrae in need of attention, and patient anatomy. All three TLIF interbody devices can be used in conjunction with the InFill Graft Delivery System to provide for a controlled fill, for contact between bone graft material and the vertebral endplates.
Pinnacle also received FDA 510(k) clearance on its InFill ALIF interbody device, with a design optimized for the L5 – S1 space. This device can also take advantage of the InFill Graft Delivery System, offering the surgeon and patient a controlled fill of the disc space with the bone graft material required to initiate fusion.
Finally, the Company received FDA 510(k) clearance for two InFill Cervical interbody fusion devices. The Cervical Lordotic product offers a form factor that emphasizes lordotic angle, while the Cervical Anatomic product is designed for endplate preservation.
Taken together with the current direct lateral and TLIF products, these clearances give the Company a far broader range of solutions for surgeons.
“We are excited to announce that we have greatly expanded our product portfolio and extended the ability to capitalize on our patented InFill Graft Delivery system. We believe that creating contact with the graft material and the vertebral endplate creates a robust fusion column. The InFill system is the first to achieve it easily and practically,” says Zach Sowell, Vice President of Marketing. “Remember, fusion is a contact sport!”
About Pinnacle Spine Group, LLC
Pinnacle Spine Group is committed to developing spinal fusion systems that improve the results for the patient, surgeon and hospital. Based around the concept of delivering a more complete fill of the disc space with graft material, the company believes it can enhance outcomes for all parties.