FDA Clears HAPPE Spine’s INTEGRATE-C Interbody Cages

HAPPE Spine has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its INTEGRATE-C interbody fusion system.
 
According to the company, INTEGRATE-C is the first interbody fusion cage that’s fully integrated with porosity and hydroxyapatite for an improved healing environment. Interconnected, cancellous porosity promotes bone ingrowth from endplate to endplate.
 
The hydroxyapatite is exposed on all surfaces in order to stimulate cell signaling and bone on-growth. INTEGRATE-C is also radiolucent and radiovisible for improved intra-operative and post-operative imaging.
 
INTEGRATE-C comes in a variety of sizes and lordotic angles to accommodate patient anatomy. Commercialization strategy is focused, at present, on limited user release and establishment of efficacy with clinical data.
 
Andrew Iott, CEO of HAPPE Spine told the press, “We are very excited to have gained 510(k) clearance for HAPPE’s new innovative technology and look forward to launching game-changing product solutions in the near future. The combination of cancellous porosity with hydroxyapatite exposed on all pore surfaces represents a true leap forward in interbody fusion devices.”
 
Dr. Stephen Smith, MD, neurosurgeon at the Beacon Health System and a co-inventor of the HAPPE technology said, “Our team at HAPPE is proud and excited to share this advancement with our colleagues. We have achieved our goal of developing an ACDF that is distinguished from all other existing devices used for interbody fusion. The HAPPE INTEGRATE-C delivers superior radiographic visibility, optimum biomechanical properties for both load bearing and healing, and true graft incorporation.”
 
Dr. Daniel Riew, MD, professor of orthopedics and a leading expert in cervical spine surgery said, “I look forward to utilizing HAPPE’s innovative product, which has all the radiographic and clinical benefits of a synthetic cage while overcoming the negative aspects of an inert, hydrophobic PEEK device that cannot osteointegrate.”