Pioneer Surgical Technology Receives 510(k) Clearance To Market Next Generation Pedicle Screw System

Marquette, MI - Pioneer Surgical Technology, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its LowTop pedicle screw system to treat a variety of spinal disorders.

"LowTop, in the true Pioneer spirit of unique design and innovation, holds great promise in offering spine surgeons additional flexibility with next generation technology to treat a broad range of deformities and physical anatomies," according to CEO Matthew N. Songer, M.D.

LowTop's low profile design, coupled with its unique ‘no torque' locking feature, will offer surgeons a user-friendly pedicle screw system complete with poly axial and fixed screws in a variety of modular and pre-assembled size ranges which should reduce operating room time and improve patient outcomes. In addition, the poly axial screw has the unique ability to be locked in any position prior to the locking of the rod which allows for compression, distraction and rod rotation prior to the final lock.

Pioneer acquired global rights to LowTop's novel pedicle screw locking system design in 2007 from AlpineSpine, LLC. LowTop is expected to be in limited market release later this year.

SOURCE: Pioneer Surgical Technology