MORRISTOWN, N.J., Aug. 19, 2015 /PRNewswire/ — Tyber Medical, LLC, a privately held medical device company focused on developing innovative orthopedics and spine devices for private label opportunities, announces FDA 510(k) clearance for TyWedge™ Opening Osteotomy Wedge Systems, a titanium plasma sprayed PEEK wedge implant.
TyPEEK®, a proprietary titanium plasma sprayed PEEK implant specifically indicated for fusion, is now available for the Tyber Medical TyWedge Opening Osteotomy Foot system. 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 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 radiographic markers for intraoperative visualization and simple instrumentation for precise implant placement. The TyWedge comes in two configurations with a total of 15 footprints: The Evans TyWedge with nine foot prints and the Cotton TyWedge which will launch with six foot prints.
“The TyWedge system marries the radiolucency of PEEK-Optima® with the Osseointegration properties of titanium allowing for direct visualization of the healing process,” commented Selene G. Parekh, MD, Associate Professor, Department of Orthopedic Surgery, Duke University.
“This FDA clearance is an important milestone for Tyber Medical where a superior wedge design allows for fusion with the use of allograft or autograft for an optimal flat foot opening osteotomy correction,” said Chris Faresich, TyWedge Team Leader.
The TyWedge system adds another titanium plasma sprayed PEEK system to Tyber Medical’s comprehensive portfolio of CE Marked and FDA approved private labeled implants. Tyber Medical’s portfolio now includes over 26,000 different product configurations across 15 different product lines, including the first available titanium plasma sprayed Evans and Cotton Wedge System.
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 Foot Wedge System is made with PEEK-OPTIMA® from Invibio® Biomaterial Solutions.