HAPPE Spine, a medical device company focused on bringing innovative materials to orthopedic implants, announces that the company's INTEGRATE-C Interbody Fusion System has received 510k clearance from the FDA.
Powered by the HAPPE platform, INTEGRATE-C is the first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to provide a superior healing environment. The interconnected, cancellous porosity promotes bone ingrowth from endplate-to-endplate. Hydroxyapatite is exposed on all surfaces to promote cell signaling and bone on-growth. The INTEGRATE-C is both radiolucent and radiovisible for superior intra-operative and post-operative imaging.
The INTEGRATE-C system offers a multitude of sizes and lordotic angles to accommodate patient anatomy. The company's commercialization strategy is presently focused on a limited user release to establish efficacy with clinical data.
