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MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating quides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7. For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle. The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patientspecific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.

MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Cervical Guide fitting the patient's vertebral anatomy. The MySpine Cervical Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

The FIREFLY® Cervical Navigation Guide system is intended to provide mechanical guidance for the preparation and drilling of pilot holes for the placement of posterior cervical spine (C1-C7) and the upper thoracic spine (T1-T3). Pilot holes are created using the FIREFLY® Cervical Navigation Guide in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) during open, posterior spinal fixation procedures, on skeletally mature patients, that are intended for fusion. The patient's pedicles, pars, or lateral masses must be dimensionally adequate to safely accommodate a posterior cervical screw, as determined on a preoperative CT/CTA scan. The FIREFLY® Cervical Navigation Guide system is compatible with FDA cleared, legally marketed, posterior cervical screw systems (and their respective components) that are specified in the precautions. Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm each pedicle's integrity. Only qualified compatible OEM posterior cervical screw system taps may be used to visually guide the tapping of pilot holes. All other posterior cervical screw system components and accessories (including non-visually guided taps) are to be used, after removal of the FIREFLY @ Cervical Navigation Guide, as directed by the posterior cervical screw system's instructions for use. The FIREFLY® Cervical Navigation Guide system is only compatible with consoles systems (attachments and burs) listed in the precautions. This system (guide, bone model, drill bit, and depth stop) are intended for single use only.

The FIREFLY® Cervical Navigation Guide is intended to assist in the accurate placement of posterior cervical screws. It consists of single-use components designed for treatment of a specific patient. The FIREFLY® Cervical Navigation Guide uses Patient-Specific Cervical Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT/CTA imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) for placing screws following the Approved Patient-Specific Surgical Plan. Patient-Specific Bone Models are also provided.