LDR, a provider of spinal implants for both non-fusion and fusion applications, has submitted pre-market approval (PMA) application to FDA on 14 January for its single-level Mobi-C cervical artificial disc.
The controlled mobility of the Mobi-C polyethylene insert is designed to accommodate the segmental instantaneous axes of rotation, thereby eliminating the need for invasive vertebral anchorage such as screws or keels.
The system instrumentation is designed to facilitate the insertion of the device with little disruption to the cervical spine.
The IDE study results represent additional clinical evidence to support the eventual use of the Mobi-C cervical disc to treat patients in the US as well.
LDR believes the addition of the cervical non-fusion device to its US product offering will position it for continued growth and success in the artificial cervical disc market.
LDR president and CEO Christophe Lavigne said he was satisfied to submit the study results to the FDA and we are very pleased with the preliminary study outcomes.