LDR Medical (Austin, Texas) received an Approval Letter from the FDA paving way for the company’s Mobi-C metal and polyethylene cervical disk mobile bearing prosthesis to come U.S. to market. This would be the first cervical implant available in America to treat two adjacent levels of damaged disks.
The Mobi-C is applicable for both one and two level procedures, and the company touts its low-profile, easy control for the surgeon, and reliable anchorage.
FDA has determined that Mobi-C is approvable for two-level indications, subject to the satisfaction of all applicable requirements of the Quality System Regulations (21 CFR Part 820), as well as finalization of the labeling and post-approval study. FDA will issue an approval order, allowing commercial sale and distribution, after said requirements have been reviewed and determined to be acceptable.
“The Mobi-C two-level study data, as presented at the North American Spine Society (NASS) 2012 Annual Meeting, demonstrate the potential to treat two-level cervical disease using the Mobi-C Cervical Disc as an alternative to ACDF,” said Dr. Reginald Davis, Chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center. “The anticipated full approval of Mobi-C will give surgeons a valuable treatment option for patients with two-level disease, where there is no approved motion preserving option.”
Product page: Mobi-C…
Press release: LDR Receives Approvable Letter from U.S. Food and Drug Administration for Two-Level Mobi-C® Cervical Disc
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