ATLANTA, June 29, 2017 /PRNewswire/ -- Meditech Spine, LLC, announced today it has received 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP allows surgeons to utilize the lumbar plating system along with Meditech's innovative lumbar Talos® fusion devices, which are manufactured with PEEK-OPTIMA™ HA Enhanced polymer offered by Invibio Biomaterial Solutions. These devices are essential in the market, as an estimated 25 percent of thoraco-lumbar interbody fusions are performed via the anterior and lateral approaches.
The CURE LP is:
A low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent bone screws anchored on the spine from loosening and backing out.
Designed with a large graft window for viewing the interbody space.
Pre-lordosed for lumbar sacral applications.
Available for both anterior and lateral procedures as four-hole or two-hole plates.
"As the anterior and lateral surgical approaches continue to grow, especially as they relate to global sagittal balance and alignment of the spine, we are pleased to receive this clearance so quickly after the clearance for our ALIF and LLIF Talos® HA Peek spacers earlier this month," says Eric Flickinger, co-founder of Meditech Spine. "This accomplishment is really a testament to our team for their focused efforts in achieving two major milestones this year, and we are privileged to add value to our implant solutions for surgeons and their patients."
The CURE LP and Talos®-A (HA) Lumbar IBF device will be combined in one tray with streamlined instruments to make it easier for hospital and surgery centers to process the system. Both systems will be provided sterile and pre-packaged to reduce implant related infections and help with implant tracking.
Meditech began its partnership with CURE International, an organization that serves children with physical disabilities in underserved areas of the world, during the development of its CURE Anterior Cervical Plate (ACP), introduced last year. "We are excited to continue building upon our relationship with CURE International and inspired to see how they work tirelessly around the world, bringing healing and hope to those who are less fortunate," says Flickinger. A portion of proceeds from the sale of every CURE LP plate will help CURE International treat patients in underserved areas who are in need of surgical care.
Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech's pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies.