(16 days)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
The components in the Solanas® Posterior System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.
· Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- · Spondylolisthesis
- · Spinal Stenosis
- Fracture/Dislocation
- Atlanto/Axial fracture with instability
- · Revision of previous cervical spine surgery
- Tumors.
The Solanas® Posterior Stabilization System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracic areas of the spine (C1-T3).
The purpose of this submission is to obtain premarket clearance for Co-Cr28-Mo6 rods for the Solanas® Posterior Stabilization System and to demonstrate that the subject device, Solanas® Posterior Stabilization System, is substantially equivalent to the predicate devices. Co-Cr28-Mo6 rods are for cervical/thoracic use only.
This document is a 510(k) premarket notification for the Alphatec Spine, Inc. Solanas® Posterior Stabilization System. It details the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving that a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or AUC for an AI-powered medical device.
The document primarily focuses on demonstrating the substantial equivalence of modifications (specifically, the addition of Co-Cr28-Mo6 rods) to an existing spinal fixation system. The "Performance Data" section mentions "Static and Dynamic Compression Bending, Static and Dynamic Torsion and Axial Grip" tests, which are typical mechanical tests for spinal implants, not algorithmic performance evaluations.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of an AI-powered medical device for this specific document.
§ 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.