Meditech Spine received an additional 510(k) clearance for the Cure Lumbar Plating System.
Here are five things to know.
1. The Cure LP is a low profile titanium plate with proprietary, one-step locking mechanism designed to prevent screw loosening and back out.
2. The new FDA-cleared indication covers additional sizing options for surgeons.
3. Surgeons can use the Cure LP with the lumbar Talos fusion devices, which are manufactured with PEEK-OPTIMA HA Enhanced Polymer.
4. Cure LP anterior plates, sacral plates, iView and Qmax plates from Meditech are now combined on one tray with streamlined instruments to make it easier for hospitals and ASCs to process.
5. Systems will have sterile packaging to help track devices while reducing infections.
"Surgeons now have the flexibility of choosing from multiple plate configurations for their patients that require supplemental fixation," said Meditech Spine Co-founder Eric Flickinger. "When coupled with our Talos-A (HA) Interbody Fusion Device, manufactured with our next generation osteoconductive polymer, we provide a full and robust system for surgeons who utilize the anterior and anterior-lateral approaches to treat degenerative spinal conditions."