MORRISTOWN, N.J., Feb. 9, 2016 /PRNewswire/ -- Tyber Medical LLC, a privately held medical device company focused on developing innovative orthopedics and spine devices for private label opportunities, announces The Full Market Release for the TyWedge™ Osteotomy Wedge Systems, a sterile titanium plasma sprayed PEEK wedge implant.
TyPEEK®, a proprietary titanium plasma sprayed PEEK coating specifically indicated for fusion, is now available for the Tyber Medical TyWedge™ Osteotomy Wedge Systems. The TyWedge™ system features the radiolucent properties of PEEK with a titanium plasma spray coating, as well as an optimized tooth profile for initial stability, allowing for a versatile uncompromised system for angular corrections in the foot. Along with the great benefits mentioned above, the TyWedge™ System is optimized for bone graft (autograft or allograft) containment, has simple radiographic markers for intraoperative visualization and instrumentation for precise placement.
"The TyWedge™ system is backed by leading peer reviewed literature which demonstrates osteo-conductivity of titanium plasma sprayed PEEK and the resultant effect of bone ingrowth. The combination of two elegant biomaterials, titanium (for osteo-integration) and PEEK (for intraoperative and postoperative visibility), is another example of our team's commitment to engineer products beyond just mechanical devices, but also bioengineering at the cellular level, says Jeff Tyber, CEO and President of Tyber Medical.
"For the past several months, we have used the system to perfect the instrumentation, validate the indications for use and authenticate the ease of use which all have been done with great success. The TyWedge™ is ready to be the first and only PEEK with titanium spray technology on the market today," says Eric J. Dickson, Global Director of Business Development, Tyber Medical.
The full market release of the TyWedge™ system adds another titanium plasma sprayed PEEK system to Tyber Medicals successful comprehensive portfolio of CE Marked and FDA approved private labeled implants. Tyber Medical's portfolio now includes over 26,000 different product configurations contained across 15 different product lines, including the first available titanium plasma sprayed Evans and Cotton Wedge System. All of these technologies are available through Tyber Medical private label partnerships.
About Tyber Medical:
Tyber Medical, LLC, Morristown, New Jersey, a private labeler Original Equipment Manufacturer (OEM), is creating new pathways to regulatory approved implants and instruments for orthopedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Current products include the opening osteotomy system, headless compression screws, cervical plating system, lateral retractor system and spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK®, a proprietary titanium plasma sprayed PEEK. For more information, please visit www.tybermedical.com.
The TyWedge™ Evans & Cotton Osteotomy Wedge System is made with PEEK-OPTIMA® from Invibio® Biomaterial Solutions.
Eric J. Dickson
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960
SOURCE Tyber Medical, LLC