Alphatec announced that it has received 510(k) FDA clearance for its Solus anterior lumbar interbody fusion system.
The Solus device features an integrated fixation method based on intellectual property previously acquired by the company. The patented fixation technology allows for enhanced segmental stability with a simplified surgical technique, while providing for substantial spacing to add bone graft.
The device is a pre-assembled unit, with no screws or anchoring plates to be passed into and out of the wound area. The fixation device rotates on a central axis, which greatly reduces the required retraction of soft-tissue, further reducing potential complications.
“We are extremely pleased to announce that the Solus system is available for commercial release within the United States,” said Dirk Kuyper, president and CEO, Alphatec. “Our exhaustive pre-clinical biomechanical testing demonstrates excellent product performance when compared to the devices currently available for sale.” Kuyper also said, “We are excited to immediately commence our controlled launch strategy, with a full commercial release in the second half of 2011. In order to optimise the success of this revolutionary product, the controlled launch will be a tiered release, with an emphasis on both clinician and sales training.”
The Solus device has been CE marked for sale in the European Union.