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Osteotech receives FDA clearance for GraftCage TLX spinal implant
By Angela McDaniels
Seattle, Dec. 20 - Osteotech Inc. said the Food and Drug Administration has cleared its 510(k) Premarket Notification Application for the GraftCage TLX System, the second approval for Osteotech's GraftCage product line in the last two weeks.
"We now have FDA clearance to distribute two different products in our GraftCage product line, the GraftCage ACX and GraftCage TLX, both of which we anticipate distributing in the first quarter of 2006," president and chief operating officer Sam Owusu-Akyaw said in a company news release.
"These two new products, along with additional GraftCage product line extensions we expect to introduce in 2006, will allow Osteotech to compete in that portion of the spinal interbody market dominated by PEEK products, which in 2005 approximates $221 million."
The GraftCage TLX is intended to replace a collapsed, damaged or unstable vertebrae in the thoracic or lumbar spine, the company said. It is made with Invibio's PEEK-Optima polymer and uses Osteotech's Xpanse bone inserts.
"When used together, the GraftCage products and the Xpanse bone inserts create a unique vertebral body spacer allowing for maximum endplate contact, structural support, osteoinductivity and osteoconductivity," Owusu-Akyaw said.
The GraftCage TLX can be implanted using existing Osteotech instrumentation and features titanium markers to aide radiographic assessments, the company said.
Medical device manufacturers are required to submit a premarket notification to the FDA if they plan to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified.
Osteotech is a biotechnology company based in Eatontown, N.J., that processes human bone and connective tissue for transplantation and develops biologic, biomaterial and device systems for musculoskeletal surgery.
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