K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) for expanded indications of its Mesa Mini and Denali Mini spinal systems.
The Mesa Mini and Denali Mini spinal systems function as adjuncts to fusion, providing stabilisation of the posterior cervical and thoracic spine. Both systems were previously cleared for use in the posterior thoracic spine, from T1-T3. The new clearance allows for the systems to be used in the posterior cervical spine, from C1-C7, in addition to the thoracic spine.
“With this FDA clearance, we are excited to provide surgeons treating the cervico-thoracic regions of the spine with expanded use of our systems,” states Eric Major, K2M’s president and chief executive officer.
The Mesa Mini and the Denali Mini systems are 3.5mm diameter rod systems that offer all-inclusive answers for rigid posterior fixation of the cervico-thoracic regions of the spine. The systems feature multiple hook and rod options, and instrument technology designed to facilitate more efficient intraoperative use of the systems.
Developed using K2M’s Mesa technology, Mesa Mini features low-profile, 90° range of motion cervical and thoracic screws and Zero-Torque technology, which is designed to offer surgeons the ability to one-step lock without applying torsional stress to the spine. The Denali Mini implants feature top-loading, 50° polyaxial range-of-motion cervical and thoracic pedicle screws that incorporate a low-volume design and offer off-axis height adjustment.