Meditech Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a new lumbar plate option CURE Opel-L (S) system.
The system adds on to the company’s previously FDA-cleared CURE LP Plate System and pairs with its Talos-A (HA) Interbody system. The clearance will enable Meditech Spine to offer an Interbody / Plate assembly for the anterior lumbar spine.
The combination of the Opel-L (S) and the Talos-A (HA) Interbody systems will provide surgeons with a lower profile system and streamlined technique. It will help improve surgical efficiency while maintaining a robust anterior stabilisation.
It will also enable surgeons to accommodate individual patient anatomy.
Additionally, the new system has increased screw angulation and repeatable, more precise A/P alignment with an optional all-in-one drill guide during the placement of the device.
Meanwhile, Meditech is also rolling out hyper-lordotic sizes to its existing Talos-A (HA) line of osteoconductive PEEK-OPTIMA HA Enhanced ALIF implants.
With the existing CURE LP system and the FDA clearance of Opel-L (S), the company offers a comprehensive anterior lumbar system, providing surgeons with different options when treating complex anterior lumbar spinal procedures.
Meditech will donate a portion of proceeds from the sale of every plate to help CURE International to treat patients who are in need of surgical care.
The company expects to launch the integrated system in the third quarter of this year.
In 2017, the company received 510(k) clearance from FDA to market its Talos Lumbar (HA) Peek IBF lumbar fusion device.