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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. This 510(k) submission adds four types of components to the system: 1) Transition Connector, 2) Transition Bone Screws, 3) Two-Post Connector, and 4) Two-Post Bone Screws. These components, when utilized with the existing standard Revolution™ connectors and standard bone screws, allow stabilization of multiple levels of the spine. Like the existing bone screws, the Transition and Two-Post bone screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Transition Bone Screws and Two-Post Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. The Transition Connector and Two-Post Connector effectively create two threaded posts from a single bone screw. These threaded posts are utilized to connect to the Revolution™ Connectors. The standard Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System. including the new multi-level components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) premarket notification for the Revolution™ Spinal Fixation System, which is a medical device and not an AI/ML regulated device. Thus, the provided information does not contain the requested details on acceptance criteria and a study that proves a device meets them in the context of AI/ML performance.

Therefore, I cannot provide the requested information.

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