HAPPE Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its INTEGRATE-C interbody fusion system.
INTEGRATE-C, which is powered by the Hydroxyapatite Porous Polyetheretherketone (HAPPE) platform, is claimed to be the first interbody fusion cage that is wholly integrated with porosity and hydroxyapatite to provide a better healing environment.
The interconnected and cancellous porosity facilitates the ingrowth of bone from endplate to endplate. The system is both radiolucent and radio visible for intra-operative and post-operative imaging.
Beacon Health System neurosurgeon Dr Stephen Smith 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’s 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.”
The INTEGRATE-C system provides various sizes and lordotic angles to meet the anatomical requirements of the patients.
Currently, the firm’s commercialisation strategy is focused on a limited user release to validate the product’s efficacy through clinical data.
HAPPE Spine CEO Andrew Iott said: “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.”
HAPPE Spine is engaged in the designing and commercialisation of advanced orthopaedic and spinal implants using its patented HAPPEmaterial platform.