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SINTX Technologies held a successful 510(k) pre-submission meeting with FDA concerning the potential development and commercialization of silicon nitride-PEEK (FleX-SN PEEK) spine implants.
In the meeting, FDA officials provided feedback related to the company’s underlying regulatory assumptions and strategies. SINTX intends to utilize FDA’s guidance to move forward with its 510(k) filing and initiate commercialization efforts to introduce spine implants made of its novel FleX-SN PEEK composite material. FleX-SN PEEK is among a new line of biomedical innovations created by the company and is not restricted to any exclusive commercial partner.
To create FleX-SN PEEK, SINTX partnered with Solvay to enhance their Zeniva PEEK biomaterial which already features a favorable material modulus and an established clinical track record. The resultant FleX-SN PEEK product is expected to facilitate faster bone healing, improve radiographic imaging, avoid metal ion release in the body and have broad-spectrum resistance to infection. This makes the composite material attractive for many surgical applications such as spinal implant surgery. Individually, both silicon nitride and PEEK are already FDA-cleared for human implantation with many years of clinical success.
SINTX submitted a Master Access File for FleX-SN PEEK to FDA in early 2021. This file can be referenced under license by SINTX customers using the material for new medical implant designs and products. SINTX continues to collaborate with many partners around the world in the development and testing of novel embodiments and applications of silicon nitride and other advanced ceramic materials. A recent acquisition of Technology Assessment & Transfer expanded the company’s product portfolio into other ceramic biomaterials such as zirconia and alumina for both medical and industrial applications.
“We are pleased to have made such great progress towards the commercialization of FleX-SN PEEK spine implants,” said Dr. Sonny Bal, President and CEO, SINTX Technologies. “With the guidance from the FDA in hand, we can now confidently move forward with our 510(k) submission and discussions with commercial partners. It is very reassuring that FDA has agreed with our approach towards regulatory clearance, and further agreed that a clinical trial is not required with this material.”
Source: SINTX Technologies, Inc.
