CTL Amedica Company has obtained 510k clearance from the U.S. Food and Drug Administration (FDA) to market the NITRO Interbody Fusion Cage System Household, designated K220513 and made solely of the fusion biomaterial silicon nitride. CTL Amedica is the world’s unique supplier of silicon nitride spine merchandise.
DALLAS (PRWEB) MAY 18, 2023 –
CTL Amedica Company has obtained 510k clearance from the U.S. Food and Drug Administration (FDA) to market the NITRO Interbody Fusion Cage System Household, designated K220513, made solely of the fusion biomaterial silicon nitride.
“We’re excited to announce the FDA 510k clearance to solely market the following technology of silicon nitride implants, the NITRO Interbody Fusion Cage System Household, which we imagine can be of even higher profit to spine surgeons and their sufferers,” mentioned CTL Amedica CEO Daniel Chon. “The merchandise on this new silicon nitride household characteristic all of the distinctive biomaterial properties the market has grown to like, with revolutionary enhancements for an excellent higher osteogenic and bacteriostatic response.”
CTL Amedica continues to be the world’s unique supplier of silicon nitride spine merchandise, which display higher protein absorption, elevated osseointegration and higher bone progress, enhancing the osteogenic response and accelerating fusion. As well as, the fabric has distinctive bacteriostatic properties, supplies artifact-free imaging, and is suitable with all imaging modalities.
Along with the innate fusion traits of silicon nitride, the merchandise within the NITRO Interbody Fusion Cage System Household incorporate various superior options:
- Exactly drilled axial pores promote capillary motion and a pathway for built-in bony through-growth
- Macro texturing all through the implants’ expanded floor will increase the world of bony contact and enhances the innate bacteriostatic properties
- Sturdy number of integration choices, lordotic choices, and dimension configurations present higher operative flexibility
The NITRO Interbody Fusion Cage System Household consists of the next:
- 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 provides that the MATISSE NITRO ACIF Cage System would be the first-to-market, with launch anticipated in Q3 2023. The remaining techniques will observe all through the rest of 2023.
CTL Amedica is a forward-thinking medical system design, growth and manufacturing firm. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, together with a Pennsylvania-based R&D Middle of Excellence. A frontrunner within the medical system know-how and biomaterials house, CTL Amedica supplies a full line of cervical, thoracic and lumbar fusion and fixation merchandise. For extra info, go to https://www.ctlamedica.com/.