FDA reclassification represents acknowledgement that pedicle screw fixation offers appropriate treatment for additional spinal conditions

For Immediate Release

November 4, 1998

Contact:	Darla Jannetty
	Manager, Corporate Communications
	Spinal Concepts, Inc
	1-800-326-0635

Austin, Texas -- November 4, 1998- Spinal Concepts, Inc. today announced that they received FDA pre-market clearance for expanded pedicle screw use for their BacFix stainless steel and titanium Spinal Fixation System in response to the July 27th FDA Federal Register notice announcing the reclassification of pedicle screw spinal systems.

The pre-market clearance expands the use of the BacFix system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformaties of the thoracic, lumbar and sacral spine. Specific acute and chronic instabilities as well as deformaties include degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Levels of pedicle screw attachment for pedicle screw fixation range from T1 to the sacrum. Previous indication for pedicle screw fixation was limited to L3 to the sacrum.

"Reclassification of pedicle screws for certain spinal applications represents a significant and positive step in the regulation of pedicle screw systems and signifies increased confidence in the safety and effectiveness of pedicle screw techology," said Teena Augostino, Director of Regulatory and Clinical Affairs for Spinal Concepts, Inc.

"Spinal Concepts' receipt of FDA pre-market clearance for expanded pedicle screw use comes at a time of tremendous growth in sales for the BacFix system. Spinal Concepts is pleased that the FDA has recognized the safety and effectiveness of pedicle screw fixation systems," said Vincent Jannetty, President and CEO of Spinal Concepts, Inc.

Spinal Concepts, Inc, based in Austin, Texas, is a privately held medical device company dedicated to providing the surgical community with safe, advanced technological spinal implant products used in the treatment of spinal disorders, diseases and injuries.