HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System
GRAND RAPIDS, Mich., May 8, 2023 /PRNewswire/ — HAPPE Spine, a medical device company focused on bringing innovative materials to orthopaedic 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.
Andrew Iott, CEO of HAPPE Spine said, “We are very excited to have gained 510K 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.”
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.
About HAPPE Spine:
HAPPE Spine was founded by Dr. Ryan K. Roeder, a Professor at the University of Notre Dame and CTO of the company. HAPPE Spine LLC is a medical device development company that designs and commercializes innovative orthopedic and spinal implants utilizing the patented Hydroxyapatite Porous Polyetheretherketone (HAPPE®) material platform. HAPPE transforms polyetheretherketone from a hydrophobic, inert, and non-integrating material into a hydrophilic, surface active, and osteointegrating material, confirmed by robust bone in-growth and on-growth in preclinical testing. In vitro performance or animal studies may not be representative of clinical performance. The HAPPE INTEGRATE-C™ interbody fusion system is the first to offer bone-like cancellous porosity with exposed hydroxyapatite on the pore surfaces, as well as porosity extending across the entire implant height to promote endplate-to-endplate osteointegration. INTEGRATE-C™ is designed to promote both load bearing and healing, as well as superior post-operative imaging. The HAPPE INTEGRATE-C™ interbody fusion system thus offers allograft-like qualities in a synthetic implant that may improve clinical outcomes in interbody spinal fusion by overcoming the problems of pseudoarthrosis, subsidence and imaging artifacts that limit current PEEK and titanium implants.
Learn more about HAPPE Spine and HAPPE® material platform at happeortho.com.
SOURCE HAPPE Spine