Integrate-C fusion cage from HAPPE Spine gets FDA 510(k) clearance
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Key takeaways:
- The FDA has given 510(k) clearance to HAPPE Spine’s fusion cage designed for endplate-to-endplate osteointegration.
- The implant features cancellous porosity, with hydroxyapatite exposed on pore surfaces, to promote bone in-growth.
The Integrate-C Interbody Fusion System by HAPPE Spine, a spinal fusion cage designed for enhanced bone ingrowth, has received 510(k) clearance from the FDA, according to a press release.
The implant features bone-like cancellous porosity from top to bottom, as well as hydroxyapatite exposed on pore surfaces, to promote endplate-to-endplate osteointegration, according to the release. The implant comes in various sizes and lordotic angles to accommodate different anatomies.
“The combination of cancellous porosity with hydroxyapatite exposed on all pore surfaces represents a true leap forward in interbody fusion devices,” Andrew Iott, CEO of HAPPE Spine, said in the release.
The device is based on the company’s patented Hydroxyapatite Porous Polyetheretherketone (HAPPE) material platform, which turns polyetheretherketone into a “hydrophilic, surface active, and osteointegrating material,” according to results from pre-clinical testing. HAPPE Spine said its commercialization strategy is focused on a limited user release to gather clinical data and establish efficacy.
A co-inventor of the HAPPE technology, Stephen Smith, MD, said the device “delivers superior radiographic visibility, optimum biomechanical properties for both load bearing and healing, and true graft incorporation.”
K. Daniel Riew, MD, an orthopedic surgeon and expert in cervical spine surgery, said the implant “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.”
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