US FDA clears Meditech’s Cure lumbar plating system

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Meditech Spine has received 510(k) clearance for its Cure lumbar plating (LP) system from the US Food and Drug Administration (FDA). The system is designed to accompany the Meditech’s lumbar Talos fusion devices, which are manufactured with PEEK-Optima hydroxyapatite (HA) enhanced polymer (Invibio Biomaterial Solutions), and also recently received FDA clearance.

The Cure LP is:

  • A low-profile titanium plate incorporating 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.
  • Pre-lordosed for lumbar sacral applications.
  • Available for both anterior and lateral procedures as four-hole or two-hole plates.

The Cure LP and Talos-A (HA) lumbar interbody fusion device are combined in one tray—both pre-packaged and sterile—with surgical instruments.

Meditech has a partnership with CURE International, an organisation 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. A portion of proceeds from the sale of every Cure LP plate will go towards CURE International.

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