(84 days)
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.