CE Mark for TyPEEK

Morristown, New Jersey-based Tyber Medical, LLC has been granted CE Mark for its TyPEEK, proprietary titanium plasma sprayed PEEK interbody system.

According to the company’s September 10, 2013 announcement, the interbody fusion device is designed to offer the benefits of bone growth with titanium along with the modulus and the post-op imaging characteristic of PEEK for situation where PEEK alone may not provide the best setting for fusion.

Mark Schenk, director of regulatory affairs and quality assurance for the company said, “Receiving ISO 13485 certification and CE Mark approval within our first year demonstrates the ability of our quality system and our team to efficiently design, develop and gain regulatory approval for products that have leading edge technology, while ensuring that they are safe and effective.”

The company says its build to order operation accelerates a sales force access to products without incurring substantial development expenses or timeline risks. Their competitive pricing targets a 75% margin or savings on all implants. All of the company’s released products have FDA and CE regulatory clearance. The systems are fully designed, tested, verified and validated using Tyber Medical’s ISO 13485:2003 and FDA QSR compliant quality system.

Steve Zeiger, the company’s director of sales and marketing told OTW, “Once a company decides they must begin to offer a product, our private label model offers the opportunity to jump past the capital expenditure and avoid the regulatory risks of internal development. Once in the market, our model reduces cogs through consolidation of manufacturing.”

The company’s interbody fusion devices include configurations for anterior cervical (ACIF), anterior lumbar (ALIF), posterior lumbar (PLIF), oblique lumbar (OLIF), transforaminal lumbar (TLIF), and direct lateral (DLIF) interbody spacers.