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Acorn Segmentation is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file. Acorn Segmentation is also intended for measuring and treatment planning. The Acorn Segmentation output can also be used for the fabrication of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications. Acorn Segmentation and 3DP Models should be used in conjunction with expert clinical judgment.

Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn Segmentation for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn Segmentation is structured as a modular package. This includes the following functionality: - Importing medical images in DICOM format - Viewing images and DICOM data - Selecting a region of interest using generic segmentation tools - Segmenting specific anatomy using dedicated semi-automatic tools or automatic algorithms - Verifying and editing a region of interest - Calculating a digital 3D model and editing the model - Measuring on images and 3D models - Exporting 3D models to third-party packages Acorn Segmentation contains both machine learning based auto-segmentation as well as semi-automatic and manual segmentation tools. The auto-segmentation tool is only intended to be used for thoracic and lumbar regions of the spine (T1-T12 and L1-L5). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal and craniomaxillofacial anatomy. Acorn 3DP Model is an additively manufactured physical replica of the digital 3D model generated in Acorn Segmentation. The output file from Acorn Segmentation is used to additively manufacture the Acorn 3DP Model.

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.

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.

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.

The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use. Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be 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 a patient-specific system 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.