Dec 28, 2007
THEKEN RECEIVES FDA CLEARANCE FOR A
SIXTH PRODUCT IN 2007
BodyForm™ Thoracic Fixation System Positions Theken to more fully serve
the $216 Million Spinal Trauma/Tumor Market
AKRON, OH (December 28, 2007) Theken Spine, a leader in spinal fixation
systems, announces that the BodyForm Thoracic Fixation System received
clearance from the Food and Drug Administration (FDA) to be marketed in the
United States (US). The BodyForm Thoracic Fixation System is the sixth product
for which Theken has received FDA clearance this year.
The products are as follows:
• Vu Mesh™ Vertebral Body Replacement (Cleared April ’07)
• Atoll™ Cervico-Thoracic System (Cleared May ’07)
• x-POD™ Adjustable Vertebral Body Replacement (Cleared June ’07)
• Vu e-POD™ Vertebral Body Replacement (Cleared July ’07)
• Coral™ Spinal System – Polyaxial Friction Head, Cannulated and Fenestrated Screws (Cleared August ’07)
• BodyForm™ Thoracic Fixation System (Cleared December ’07)
The addition of the BodyForm Thoracic Fixation System in conjunction with the
BodyForm Thoraco-Lumbar Fixation System enables Theken to provide trauma/tumor plates for the spine regions from T1-L5.
Theken now is able to more fully serve the $216 million spinal trauma/tumor market*. The BodyForm System may be used in combination with Theken’s x-POD Adjustable Vertebral Body Replacement or Vu Mesh Vertebral Body Replacement to provide a complete trauma/tumor solution. With this product combination, Theken plans to aggressively target Trauma Centers throughout the US.
Theken now can provide surgeons a product offering that includes fixation solutions and biologics for conditions located in every region of the spine. The BodyForm Thoracic Fixation System is currently in alpha product launch.
The system includes low profile titanium plates, screws and locking screws that secure vertebra for the treatment of spinal instability. Theken currently offers a trauma/tumor plate for the thoraco-lumbar region of the spine (T10-L5).
∗Millennium Research Group US Markets for Spinal Implants 2007 Exhibit 3-2 pg. 49 www.MRG.NET
About Theken, a family of companies
The Theken (Pronounced ‘tay-ken’) family of companies Theken Spine, LLC, Theken Disc, LLC, Theken Orthopaedic, Inc. and Therics, LLC (www.theken.com) specializes in pioneering spinal implant technologies that improve spinal surgical techniques benefiting patients as well as surgeons. Theken provides comprehensive product lines that offer surgeons peace of mind through steadfast product reliability and easy-to-use instrumentation. Products include cervical
plates, pedicle screws, spacers, degenerative/deformity and trauma devices. Theken also leads the market in next generation artificial disc replacement technology.
Director of Communications
Other company and product names mentioned herein may be trademarks or registered trademarks of their respective
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