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Orthofix announces 510(k) clearance, limited launch of expandable fusion spacer system
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Orthofix International N.V. announced the 510(k) FDA clearance and U.S. limited market launch of the Forza XP Expandable Spacer System intended for spine fusions in skeletally mature patients with degenerative disc disease at one or two contiguous lumbar levels.
According to a press release, the spacer system expands after insertion into the disc space to fit the patient’s anatomy. The Forza XP, which is made mostly of titanium alloy, is used for either posterior or transforaminal lumbar interbody fusion.
The expandable device is meant to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, such as Orthofix Trinity Elite allograft tissue with the Firebird Spinal Fixation System.
“The Forza XP Expandable Spacer System is a strong addition to our robust portfolio and makes Orthofix competitive in one of the fastest growing segments in spine,” Ray Fujikawa, president of Orthofix Spine Fixation, said in the press release. “This new system offers an industry-leading 6.5-mm starting height and also enables surgeons to place bone graft material inside the device after implantation. The ability to pack our new expandable device with bone graft post-expansion is extremely important to ensure proper contact of the material with the vertebral endplates.”
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