The U.S. Food and Drug Administration has awarded 510(k) clearance to Spine Innovation LLC’s LOGIC Titanium Implant System.

The product incorporates OsteoSync Ti, a patented, pure titanium lattice material, and is designed with a reduced profile during implantation that more than doubles in size during expansion for maximum stability and bone graft volume. The design has been used successfully in the United States for a decade, manufactured from polyether ether ketone (PEEK). The implant restores disc height and sagittal balance while resisting subsidence and expulsion due to an 18 mm x 26 mm expanded footprint spanning the vertebral body.

The LOGIC Expandable Interbody is inserted on its side to minimize the risk of neural injury and is easily rotated 90 degrees in its closed configuration to restore disc height up to 14 mm and lordosis up to 15 degrees. The implant is then expanded 10 mm laterally to create an implant width of 18 mm with a large 10 mm by 26 mm graft area that is directly accessible by the surgeon for placing bone graft in the device. Additional bone graft placed contralaterally before implantation is further compacted by implant expansion, enabling a total of 15 mL to 20 mL of bone graft placement per fusion level.

The LOGIC device increases the implant profile in height, lordotic angle, and footprint in situ. The bone graft window and filling aperture are among the largest of all expandable TLIF devices currently available, according to the company. Implant stability and resistance to subsidence and expulsion are also maximized by the product’s lateral expansion.

LOGIC’s OsteoSync porous titanium material features 60% porosity, an average 523μm pore size, and an interconnected average pore size of 229 μm—ideal macro-scale features for significant bone ingrowth. Developed by Sites Medical, the substance has been implanted in more than 250,000 patients since 2014. OsteoSync Ti has shown potential for faster healing times and improved implant osseointegration,¹ and offers a high coefficient of friction for improved initial implant stability, which is essential for long-term bone ingrowth.  

Spine Innovation LLC is a medical device startup founded in 2013 in collaboration with surgeon inventors from Scripps Health (San Diego) to address unmet clinical needs. Spine Innovation is seeking U.S. sales and distribution partners to expand its clinical use of the LOGIC implant.

Reference
¹ Bone Ingrowth Performance of OsteoSync Ti. (2007). https://www.machmedicalcmo.com/wp-content/uploads/2020/10/bone_ingrowth.pdf