FDAnews Device Daily Bulletin

Pioneer Receives Approval to Market Screw System

March 27, 2008

Pioneer Surgical Technology has received 510(k) clearance from the FDA to market its LowTop pedicle screw system to treat a variety of spinal disorders.

LowTop’s low-profile design, coupled with its no-torque locking feature, will include polyaxial and fixed screws in a variety of modular and pre-assembled size ranges that should reduce operating room time and improve patient outcomes, Pioneer said.

Pioneer acquired global rights to LowTop’s screw system last year from AlpineSpine. It expects to offer the product in a limited market release later this year.