(170 days)
The device system consisting of screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses: (a) anterolateral screw fixation to the non-cervical spine, (b) anterior screw fixation to the cervical spine. The anterolateral/anterior system is intended for use in the following indications: (a) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. (b) Spondylolisthesis (c) Trauma (d) Spinal Stenosis (e) Scoliosis (f) Kyphosis (g) Tumor (h) Pseudoarthrosis (i) Revision of previous surgery (j) Neoplastia. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use: (a) hook and sacral/iliac screw fixation to the non-cervical spines. The non-pedicle posterior devices may be used for the following indications: Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. (b) Spondylolisthesis (c) Trauma (d) Spinal Stenosis (e) Scoliosis (f) Kyphosis (g) Tumor (h) Pseudoarthrosis (i) Revision of previous surgery (j) Neoplastia. The device system consisting of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients: (a) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint (b) Who are receiving fusions using autogenous bone graft only (c) Who are having the device fixed or attached to the lumbar and sacral spine (d) Who are having the device removed after the development of a solid fusion mass. The levels of pedicle screws fixation will be L3-S1.
A spinal system consisting of screws, hooks, washers, spacers, rods, and rod plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5mm increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook within the range. The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicle. The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration. The pedicle screw lengths are offered in 5mm increments from 30mm to 55mm. The screw diameters are offered in 1mm increments from 5mm to 8mm diameters. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The locking mechanism between the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod pistoning and migration. The devices are manufactured from titanium alloy or stainless steel. All components are completely interchangeable with each other, but only components manufactured from the same material may be used in combination.
The provided text is a 510(k) summary for the Corin Spinal System, a medical device. It details the device's description, indications for use, and the FDA's decision regarding its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or study results (clinical or analytical) that would "prove the device meets the acceptance criteria."
510(k) summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria as one would find for a new, novel device requiring a PMA or specific performance standards.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information points (1) through (9) are not present in this 510(k) summary.
§ 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.