Michael Barbella, Managing Editor10.14.23
New product clearances and designations drove ODT website traffic this past week.
DePuy Synthes was the clear leader with news of FDA 510)k) clearances for its TriLEAP lower extremity anatomic plating system, TriALTIS spine system, and TriALTIS navigation-enabled instruments. The modular, procedure-specific TriLEAP system for forefoot, midfoot, and hindfoot elective and trauma surgeries features contoured and conventional plates that can accommodate various screw diameters and instruments designed for reduction, internal fixation, and fusion of bones and bone fragments. The TriALTIS spine system is a next-generation posterior thoracolumbar pedicle screw system with a comprehensive implant portfolio and advanced instrumentation designed to be integrated with enabling technology. The TriALTIS navigation-enabled instruments include drills, taps, and screwdrivers that can either be operated manually or under power for navigated and non-navigated use.
Intelivation amassed considerable pageviews for reporting the FDA clearance of its Hammerdesis interphalangeal fusion system. Hammerdesis allows correction of hammertoe deformities and degenerative issues by affixing a “distinctively designed” implant to the toe joint. The operation, according to Intelivation, saves intraoperative time and yields cost savings in the ambulatory surgical setting.
ZKR Orthopedics made cyberwaves by gaining FDA Breakthrough Device Designation for its LIFT implant, which was engineered to decrease pain, improve function, and delay or remove the need for knee replacement surgery. SpineX followed suit by touting neuromodulation research that has been recognized by leading scientists worldwide and published in Frontiers.
DePuy Synthes was the clear leader with news of FDA 510)k) clearances for its TriLEAP lower extremity anatomic plating system, TriALTIS spine system, and TriALTIS navigation-enabled instruments. The modular, procedure-specific TriLEAP system for forefoot, midfoot, and hindfoot elective and trauma surgeries features contoured and conventional plates that can accommodate various screw diameters and instruments designed for reduction, internal fixation, and fusion of bones and bone fragments. The TriALTIS spine system is a next-generation posterior thoracolumbar pedicle screw system with a comprehensive implant portfolio and advanced instrumentation designed to be integrated with enabling technology. The TriALTIS navigation-enabled instruments include drills, taps, and screwdrivers that can either be operated manually or under power for navigated and non-navigated use.
Intelivation amassed considerable pageviews for reporting the FDA clearance of its Hammerdesis interphalangeal fusion system. Hammerdesis allows correction of hammertoe deformities and degenerative issues by affixing a “distinctively designed” implant to the toe joint. The operation, according to Intelivation, saves intraoperative time and yields cost savings in the ambulatory surgical setting.
ZKR Orthopedics made cyberwaves by gaining FDA Breakthrough Device Designation for its LIFT implant, which was engineered to decrease pain, improve function, and delay or remove the need for knee replacement surgery. SpineX followed suit by touting neuromodulation research that has been recognized by leading scientists worldwide and published in Frontiers.
