FDA Grants CTL Amedica 510k Clearance for the NITRO Interbody Fusion Cage System Family
DALLAS, May 18, 2023 / OrthoSpineNews/ – CTL Amedica Corporation has received 510k clearance from the U.S. Food and Drug Administration (FDA) to market the NITRO Interbody Fusion Cage System Family, designated K220513, made entirely of the fusion biomaterial silicon nitride.
“We’re excited to announce the FDA 510k clearance to exclusively market the next generation of silicon nitride implants, the NITRO Interbody Fusion Cage System Family, which we believe will be of even greater benefit to spine surgeons and their patients,” said CTL Amedica CEO Daniel Chon. “The products in this new silicon nitride family feature all the unique biomaterial properties the market has grown to love, with innovative enhancements for an even greater osteogenic and bacteriostatic response.”
CTL Amedica continues to be the world’s exclusive provider of silicon nitride spine products, which demonstrate greater protein absorption, increased osseointegration and better bone growth, enhancing the osteogenic response and accelerating fusion. In addition, the material has unique bacteriostatic properties, provides artifact-free imaging, and is compatible with all imaging modalities.
In addition to the innate fusion characteristics of silicon nitride, the products in the NITRO Interbody Fusion Cage System Family incorporate a number of advanced features:
- Precisely drilled axial pores promote capillary action and a pathway for integrated bony through-growth
- Macro texturing throughout the implants’ expanded surface increases the area of bony contact and enhances the innate bacteriostatic properties
- Robust variety of integration options, lordotic offerings, and size configurations provide greater operative flexibility
The NITRO Interbody Fusion Cage System Family consists of the following:
- MATISSE NITRO™ Anterior Cervical Interbody Fusion (ACIF) Cage System
- MONET NITRO™ Standalone ACIF Cage System with Supplemental Fixation
- MONDRIAN NITRO™ Lumbar Interbody Fusion Cage System
— MONDRIAN NITRO™ ALIF/OLIF
— MONDRIAN NITRO™ DLIF
— MONDRIAN NITRO™ PLIF
— MONDRIAN NITRO™ TLIF
Chon adds that the MATISSE NITRO ACIF Cage System will be the first-to-market, with launch expected in Q3 2023. The remaining systems will follow throughout the remainder of 2023.
CTL Amedica 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. For more information, visit https://www.ctlamedica.com/.