Michael Barbella, Managing Editor12.04.23
The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico's regulatory agency that oversees medical device/product quality, has approved CTL Amedica Corporation’s MONET Anterior Cervical Interbody Fusion (ACIF) System.
The MONET ACIF System is specifically designed for anterior cervical interbody fusion procedures in patients with cervical disc disease. It includes a supplemental fixation plate that provides a comprehensive solution for interbody cage fusion, and it is tailored to meet the diverse anatomical needs of a wide variety of patients.
“This milestone is a reflection of our commitment to providing advanced medical solutions that prioritize patient well-being and surgical excellence,” CTL Amedica CEO Daniel Chon said. “We remain steadfast in our commitment to advancing spine technology.”
Key features of the MONET ACIF System:
CTL Amedica’s TiCRO surface technology offers greater surface area over predicates, significantly increasing bony endplate contact. Silicon nitride demonstrates greater protein absorption and increased osseointegration, promotes better bone growth, enhances osteogenic response and accelerates fusion. CTL Amedica is the world’s exclusive provider of silicon nitride spine products.
CTL Amedica is a medical device design, development, and manufacturing company. It maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. The company provides a full line of cervical, thoracic, and lumbar fusion and fixation products.
The MONET ACIF System is specifically designed for anterior cervical interbody fusion procedures in patients with cervical disc disease. It includes a supplemental fixation plate that provides a comprehensive solution for interbody cage fusion, and it is tailored to meet the diverse anatomical needs of a wide variety of patients.
“This milestone is a reflection of our commitment to providing advanced medical solutions that prioritize patient well-being and surgical excellence,” CTL Amedica CEO Daniel Chon said. “We remain steadfast in our commitment to advancing spine technology.”
Key features of the MONET ACIF System:
- Suitable for skeletally mature patients
- Designed for single-level fusion, covering disc levels C2 to C7
- Includes a supplemental fixation plate for added stability
- Available in a wide variety of sizes and configurations
CTL Amedica’s TiCRO surface technology offers greater surface area over predicates, significantly increasing bony endplate contact. Silicon nitride demonstrates greater protein absorption and increased osseointegration, promotes better bone growth, enhances osteogenic response and accelerates fusion. CTL Amedica is the world’s exclusive provider of silicon nitride spine products.
CTL Amedica is a medical device design, development, and manufacturing company. It maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. The company provides a full line of cervical, thoracic, and lumbar fusion and fixation products.