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MySpine MC and Drill Pilot MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: • Drill based · K-wire based MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC K-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. 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 patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used. MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. 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. The MySpine guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared posterior fixation screw system intended to be used.

MySpine Unilateral Guides are a line extension to Medacta's MySpine pedicle and sacro-iliac screw placement guides. Identically to the other Medacta MySpine products, the subject guides are single use, patient matched, pedicle targeted technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine Unilateral Guides have been designed starting from the correspondent bilateral guides which have been modified to allow the drilling of only the left or the right side of vertebra/sacrum through the left or right tube. Identically to the predicate devices, MySpine Unilateral Guides are manufactured from medical grade nylon for sintering and they can be provided in both non-sterile and sterile version.

MySpine is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of pedicle screws in the vertebral body. MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws. Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Screw placement guides are intended for single use only. MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: Drill based and K-wire based. MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only. MySpine S2-Alar/Alar-Iliac is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine S2-Alan/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides are the same of the predicate devices cleared within K200792, K173472 and K153273. Based on the predicate, different screw placement guide configurations are object of this submission, specifically: MySpine Low Profile Guides: for K-wire guidance with conventional screw trajectory; MySpine Drill Pilot Guides: guidance for pedicle path preparation with conventional screw trajectory; MySpine MC/S1 Guides: Drill Pilot and K-wire guidance with cortical bone path; MySpine S2-Alar/Alar Iliac Guides: Drill Pilot guidance with cortical bone path. The MySpine Pedicle Screw Placement Guides are for use in spinal levels T1-S2/S2AI and ilium. The MySpine Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle screws based on the patient's anatomy. 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 Pedicle Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version. The purpose of this submission is to obtain clearance of the MySpine Pedicle Screw Placement Guides for use with any compatible 510(k) cleared pedicle screw system.

MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identical to the other Medacta MySpine products, the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System (K12115, K132878, K141988, K153664, K162061, and K171170). Specifically, the subject MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. 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 Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

The FIREFLY® Midline Navigation Guide can be used with any 510(k) clearly marketed, pedicle screw spinal system (for its cleared indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures (T10-S2) intended for fusion, with the additions listed below: - o Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved) - . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis - Pedicle screw's longitudinal axis matches the direction of insertion - Pedicle screw is intended to be inserted into a pilot hole - Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® - Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan - . Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Midline Screw Navigation Guide - Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used with the FIREFLY® Midline Navigation O Guide to confirm pedicle integrity - All other pedicle screw spinal system components and accessories [including non-guided taps] are to be O used, after removal of the FIREFLY® Midline Navigation Guide, as directed by the pedicle screw spinal system's instructions for use This device is intended for single use only.

The FIREFLY® Midline Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient. The FIREFLY® Midline Navigation Guide uses Patient-Specific 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 imaging data. Navigation Guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Surgical Plan. Patient-Specific Bone Models are also provided.

The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (TI-S2/S2Al and ilium) intended for fusion, with the additional conditions listed below: - . Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved) - . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis - Pedicle screw's longitudinal axis matches the direction of insertion ● - Pedicle screw is intended to be inserted into a pilot hole ● - Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ● - Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan - . Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide - Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o - Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be O quided to tap pilot holes - All other pedicle screw spingl system components and accessories (including non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use This device is intended for single use only.

The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components. The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw 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 imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan. Patient-Specific Bone Models may also be provided.

MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: - Drill based - K-wire based MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1. The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion. The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.

The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/ilium) intended for fusion, with the additional conditions listed below: - Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved) - Pedicle screw's major and minor thread diameters are centered about the longitudinal axis - Pedicle screw's longitudinal axis matches the direction of insertion ● - Pedicle screw is intended to be inserted into a pilot hole ● - Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ● - Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan - Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide . - Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o - Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be 0 guided to tap pilot holes - All other pedicle screw spinal system components and accessories lincluding non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use This device is intended for single use only.

The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components. The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw 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 imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan. Patient-Specific Bone Models may also be provided. The purpose of this traditional 510(k) is to expand the FIREFLY® indications for use to allow compatibility with all pedicle screw systems (for their cleared indications for use) meeting certain criteria and use at an additional spinal level. The FIREFLY® design is the same as was originally cleared in K143222.