FDA Clearance for CTL Amedica’s NITRO Interbody Fusion Cage

CTL Amedica received FDA 510(k) clearance to market the NITRO Interbody Fusion Cage System, made entirely of the fusion biomaterial silicon nitride.

Silicon nitride 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 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 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

The MATISSE NITRO ACIF Cage System will be the first to market, with launch expected in 3Q23.

Source: CTL Amedica