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CarboFix Spine was granted FDA 510(k) clearance to market the CarboClear® Hybrid Posterior Cervical Screw System, a next-generation solution designed to address the complex demands of cervical and upper thoracic spine surgery.
The system is cleared for use across indications that include oncology, degenerative conditions, trauma, revision surgeries, and infections. It is indicated for fixation spanning C1 through C7 and T1 through T3.
CarboClear combines a carbon fiber-reinforced PEEK (CFRP) screw shank with an ultrathin titanium shell and titanium tulip, delivering a hybrid construct that balances imaging with intraoperative versatility and long-term biological integration.
Key Features and Clinical Benefits:
- Carbon Fiber Shank: Enables artifact-reduced imaging for improved post-operative assessment and optimized radiation therapy planning—critical in spine oncology cases
- Ultrathin Titanium Shell: Engineered to support bony on-growth while preserving intra-op visualization advantages
- Tulip Design: A smaller tulip head for limited working space in cervical/thoracic applications. Provides familiar handling and robust construct stability.
- Up to 55° Variable Angulation: Enhances intraoperative flexibility for complex cervical anatomy and challenging trajectories
- System Compatibility: Designed for seamless integration with CarboFix Spine’s fully carbon fiber posterior cervical system (also featuring the same clearances and indications), enabling hybrid or fully radiolucent constructs based on clinical preference
“The clearance of the CarboClear Hybrid Posterior Cervical System represents a significant expansion of our carbon fiber platform at the cervical spine,” said Motti Beyar, President at CarboFix Spine. “Together with CarboFix’s full Carbon Fiber Posterior Cervical system, we are providing surgeons with a complete solution that supports both advanced imaging needs and surgical performance, particularly in oncology where precision across the care continuum is essential.”
Source: CarboFix Spine
CarboFix Spine was granted FDA 510(k) clearance to market the CarboClear® Hybrid Posterior Cervical Screw System, a next-generation solution designed to address the complex demands of cervical and upper thoracic spine surgery.
The system is cleared for use across indications that include oncology, degenerative conditions, trauma, revision...
CarboFix Spine was granted FDA 510(k) clearance to market the CarboClear® Hybrid Posterior Cervical Screw System, a next-generation solution designed to address the complex demands of cervical and upper thoracic spine surgery.
The system is cleared for use across indications that include oncology, degenerative conditions, trauma, revision surgeries, and infections. It is indicated for fixation spanning C1 through C7 and T1 through T3.
CarboClear combines a carbon fiber-reinforced PEEK (CFRP) screw shank with an ultrathin titanium shell and titanium tulip, delivering a hybrid construct that balances imaging with intraoperative versatility and long-term biological integration.
Key Features and Clinical Benefits:
- Carbon Fiber Shank: Enables artifact-reduced imaging for improved post-operative assessment and optimized radiation therapy planning—critical in spine oncology cases
- Ultrathin Titanium Shell: Engineered to support bony on-growth while preserving intra-op visualization advantages
- Tulip Design: A smaller tulip head for limited working space in cervical/thoracic applications. Provides familiar handling and robust construct stability.
- Up to 55° Variable Angulation: Enhances intraoperative flexibility for complex cervical anatomy and challenging trajectories
- System Compatibility: Designed for seamless integration with CarboFix Spine’s fully carbon fiber posterior cervical system (also featuring the same clearances and indications), enabling hybrid or fully radiolucent constructs based on clinical preference
“The clearance of the CarboClear Hybrid Posterior Cervical System represents a significant expansion of our carbon fiber platform at the cervical spine,” said Motti Beyar, President at CarboFix Spine. “Together with CarboFix’s full Carbon Fiber Posterior Cervical system, we are providing surgeons with a complete solution that supports both advanced imaging needs and surgical performance, particularly in oncology where precision across the care continuum is essential.”
Source: CarboFix Spine
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
