Tyber Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its BioTy, a modified surface treatment for use on their headless screw system.
The BioTy surface treatment is a nano-scale technology, which features a process protected by various issued and pending patents.
According to the company, the technology modifies the surface characteristics of medical devices for advanced indications yet to be disclosed, which are under development through the FDA review process.
Tyber Medical R&D vice president Rui Ferreira said: "Based on initial results, we expect this technology to set the new market standard for orthopedic implants and will be applicable across the entire market."
The company has also signed a licensing agreement with Northeastern University to further expand the BioTy technology and intellectual property.
Tyber Medica, along with the university is carrying out multiple studies on BioTy to analyze cellular response with this technology.
The results from the studies are expected to support claims of a statistically significant decrease in bacterial adherence compared against non-surface modified implants.
Tyber Medical CEO and president Jeff Tyber said: "With the excellent reputation of Northeastern University as a research institute, as well as Tyber Medical’s expertise in rapid device development and surface modification, the BioTy modified surface treatment technology and exclusive licensing agreement go hand in hand with Tyber Medical’s business model of providing rapid access to portfolio enhancing technologies."
Tyber Medical produces opening osteotomy system, headless compression screws, cervical plating system, lateral retractor system, and spinal interbody spacers and others.
Currently, the firm has around 46,000 different product configurations within 22 different product lines.