New Orthopaedic Screw for Spinal Applications Approved
The LowTop Pedicle Screw System from Pioneer Surgical Technology, Incorporated has received marketing clearance (pdf) from the Food and Drug Administration. The device is indicated to treat patients with a variety of spinal conditions. A press release was posted on the company’s website containing the news of the approval.
The LowTop was created with a low profile and a ‘no torque’ locking feature. These features provide a pedicle screw that is user-friendly. This unit includes fixed screws and poly axial available in a range of pre-assembled or modular size ranges. It is supposed that these features can reduce the amount of time spent to complete an operation and support better outcomes for patients.
An additional unique feature of the system is that the locking feature of the poly axial screw can be activated in the desired position prior to locking the rod. This allows clinicians to rotate, compress, and distract the rod prior to completion of the final lock.
The original design for the newly approved system was crafted by AlpineSpine, LLC. Pioneer obtained global rights for marketing in early 2008. A limited market release of the LowTop Pedicle Screw System is planned for later this year.
April 1, 2008 Related topics: Product Approval & Certification, Psychiatry & Neurology, Orthopedic