The FDA has approved Osteotech's 510(k) application for the GraftCage ACX device, which is intended to replace a collapsed, damaged or unstable vertebral body in the thoracic or lumbar spine.
Osteotech said it expects to launch the product in the first quarter of 2006. The GraftCage ACX is designed for strength and ease of insertion by surgeons and can be implanted using existing Osteotech instrumentation, the company said.
The GraftCage ACX features titanium markers to facilitate intra-operative and postoperative radiographic assessments and an opening for the insertion of bone grafting materials to allow for maximum graft exposure. The company also said it expects to launch a new version of its bone grafting material, the Xpanse Bone Insert, with the launch of the GraftCage ACX.