Nanovis Spine LLC received U.S. Food and Drug Administration (FDA) 510(k) clearance of its sterile-packed FortiCore interbody fusion devices. According to the company, compared to devices made of polyetheretherkeytone (PEEK) or sprayed titanium coating, FortiCore implants have the benefits of a highly porous titanium scaffold engineered for "strong, durable integration" with a PEEK core.
Forticore implants are the first of three technology platforms that Nanovis plans to bring to the spine and other orthopedic markets.
“Nanovis’ mission is to lead our chosen markets with science-enhanced implants that improve lives. Based on our exiting pre-clinical data, the FortiCore interbody platform certainly promises to fulfill that mission” said CEO Matt Hedrick.
The FortiCore implant platform was developed with the guidance from surgeons and integrates the BioSyncporous scaffold licensed from SMed-TA/TD LLC, an orthopedic implant development company. Members of the surgeon design team have executed "encouraging" pre-clinical studies that the team expects to publish at a "suitable future date," company leadership said.
Carmel, Ind.-based Nanovis was founded in 2006.