Tyber Medical Receives 510 (k) Clearance For TyPEEK™ And PEEK Interbody Systems
, Oct. 9, 2013
/PRNewswire/ -- Tyber Medical, a privately held medical device company focused on developing innovative spine and orthopaedic devices for private label opportunities, announces FDA 510 (k) clearance for TyPEEK and non-sterile and sterile PEEK interbody implant systems.
TyPEEK, proprietary titanium plasma sprayed interbody fusion devices, are specifically designed for situations where PEEK alone may not provide the best setting for fusion. TyPEEK is designed to offer the benefits of bone - titanium osseointegration along with the modulus and post op imaging characteristics of PEEK.
"The optimal interbody implant would osseointegrate and have similar biomechanical properties as subchondral bone. The combination of a plasma sprayed titanium and PEEK found in Tyber Medical's interbody implant portfolio achieves this balance," commented Dr. R. Douglas Orr, a Staff physician in the Center for Spine Health and the Department of Orthopaedic Surgery, at the Cleveland Clinic. "Plasma sprayed titanium exhibits excellent bone implant interface bonding while the PEEK implant closely mimics the biomechanics of subchondral bone."
"Tyber Medical's broad range of implant sizes and configurations come closer than any other company to meeting the comfort level of each individual surgeon, as well as, the specific anatomical demands of patients," said Dr. Ira Fedder, a fellowship trained orthopaedic spine surgeon at the University of Maryland St. Joseph Medical Center and Towson Orthopedics Associates.
Both the TyPEEK and PEEK 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.
"This FDA clearance is an important milestone for Tyber Medical and a major risk we can remove for our customers," said Jeff Tyber, Chief Executive Officer of Tyber Medical. "Our comprehensive CE Mark and FDA approved private labeled interbody portfolio includes over 3,000 different product offerings, including the first available titanium plasma sprayed direct lateral lumbar 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 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.
Tyber Medical Interbody systems are made with PEEK-OPTIMA® from Invibio® Biomaterial Solutions.
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960
SOURCE Tyber Medical