FDA grants CTL Amedica 510k clearance for MONDRIAN LIF Cage System

Shared by 09/02/2020
Matt Woods

CTL Amedica Corporation has received 510k clearance from the FDA to market its MONDRIAN Lumbar Interbody Fusion Cage System featuring TiCro surface technology, a unique and innovative approach to titanium interbody fusion devices.

CTL Amedica Corporation is proud to announce that it has received official 510k clearance from the U.S. Food and Drug Administration (FDA) to market its MONDRIAN™ Lumbar Interbody Fusion (LIF) Cage System featuring TiCro™ surface technology, a unique and innovative approach to titanium interbody fusion devices.

“Using our CEZANNE™ LIF System and other cutting-edge CTL Amedica products as a foundation, our team created the MONDRIAN™ LIF Cage System, a revolutionary new product that utilizes our proprietary TiCro™ technology, which has an aggressive macro surface and unique geometry that enhances interlocking properties and increases bone ingrowth surface area,” says Daniel Chon, CTL Amedica Corporation president and CEO. “With multiple material offerings, 15 different cage configurations, 34 footprints, 7 lordotic options and 7,160 part combinations, the sheer breadth of this clearance is a tremendous accomplishment and a testament to our team’s dedication to ‘moving the needle’ in product innovation and design. We’re grateful for the clearance and look forward to presenting the MONDRIAN™ LIF Cage System to the market soon.”

The MONDRIAN™ LIF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease at one or two adjoining levels from L2-S1. The system is designed to be used with supplemental fixation cleared for use in the lower back. The robust fusion system features a large graft window, distinct radiographic markers, a self-distracting bullet tip, a bi-convex profile and lateral aperture.

“The MONDRIAN™ LIF Cage System is available in a wide variety of sizes and configurations to better accommodate anatomical variation,” adds Chon. “This enables greater intraoperative flexibility, which can result in shorter, more efficient procedures, possibly improving success rates and recovery time for patients.”

Of the robust MONDRIAN™ LIF offerings, the titanium bullet TLIF and PLIF with TiCro™ technology are scheduled for limited launch in Q4 of 2020, with other implant formats soon to follow.

CTL Amedica Corporation is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response. For more information, visit https://www.ctlamedica.com/.