Osteotech's GraftCage ACX for spinal surgery cleared by FDA

By E. Janene Geiss

Philadelphia, Dec. 13 - Osteotech, Inc. said Tuesday that the Food and Drug Administration has cleared its 510(k) application for its new GraftCage ACX for use in the thoracic and lumbar spine.

The company said it expects to launch the product in the first quarter of 2006, according to a company news release.

The GraftCage ACX is designed for strength and ease of insertion by surgeons and can be implanted using existing Osteotech instrumentation. It features titanium markers to facilitate intra-operative and post-operative radiographic assessments and an opening for the insertion of bone grafting materials, including a new form of the recently introduced Xpanse Bone Insert, to allow for maximum graft exposure, officials said.

The new version of Xpanse Bone Insert is expected to be launched concurrently with the launch of the GraftCage, officials said.

"The GraftCage ACX is the first in a series of new products from Osteotech manufactured from PEEK material that we expect to introduce into the market over the course of 2006," said Sam Owusu-Akyaw, Osteotech's president and chief operating officer, in the release.

"These products will participate in the overall spinal interbody market, which, in 2005, is approximately $558 million of which PEEK products represent approximately $221 million," Owusu-Akyaw said. "Used together, the Xpanse Bone Insert and GraftCage ACX create a unique vertebral body spacer allowing for maximum end-plate contact, structural support, osteoinductivity and osteoconductivity, which are the four key functional requirements in order to achieve a successful fusion."

The GraftCage ACX is intended to replace a collapsed, damaged or unstable vertebral body in the thoracic or lumbar spine. It is indicated for a partial or total vertebrectomy in cases of tumor or trauma related damage to the vertebral body. It also is intended to restore the height of a collapsed vertebral body, officials said.

Osteotech is an Eatontown, N.J., provider of human bone and bone connective tissue for transplantation and developer and marketer of biomaterial and implant products for musculoskeletal surgery.

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