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

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Mar 2008 - 4:00 PDT

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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.

About Pioneer Surgical Technology

Pioneer Surgical Technology, headquartered in Marquette, Michigan, is a dynamic medical device firm with a full line of cutting-edge motion preservation devices either available commercially in Europe or under clinical evaluation in the US. Pioneer's signature articulating PEEK-on-PEEK technology, in its NUBAC™ and cervical motion preservation series, is the most technologically advanced design in the industry. In addition, Pioneer's comprehensive portfolio of vertebral spacers, cervical plating systems, and MIS and Mini-Open Rod systems include familiar trade names such as Contact™, IJAK®, Clarity™, SlimFuse™, and Quantum®.

Pioneer entered the orthobiologics market with two acquisitions in 2007. Encelle™, Inc., developed E-Matrix™ for tissue regeneration. Angstrom™ Medica, Inc. is the first company to obtain FDA approval for a nanotechnology device - NanOss™ - a hydroxyapatite bone void filler.

Pioneer's three divisions…Orthopedic, Spinal and Biologic…all work to produce state of the art, cost-effective solutions for surgical procedures that have proven difficult or problematic for both surgeons and patients.

Pioneer Surgical Technology