(50 days)
The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Dakota ALIF Plate System consists of a series of plates and screw sizes, along with the necessary surgical instrumentation. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) to provide stabilization and permit spinal fusion to occur. All components are made from Ti-6Al-4V per ASTM F136 or ISO and 5832-3. The products are supplied clean and non-sterile.
The provided text is a 510(k) summary for the Dakota ALIF Plate System, a spinal intervertebral body fixation orthosis. This document does not describe an AI/ML medical device and therefore does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML product.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, typical for a traditional medical device like a spinal implant.
Specifically, it details:
- Product Name: Dakota ALIF Plate System
- Regulation Number and Name: 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis
- Regulatory Class: Class II
- Product Code: KWQ
- Indications for Use: Provides an anteriorly placed supplemental fixation for anterior lumbar (L1-S1) fixation for various conditions (degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, pseudoarthrosis, failed previous fusion).
- Materials: Ti-6Al-4V per ASTM F136 or ISO 5832-3.
- Predicate Devices: K091044 (Spinal USA Anterior Lumbar Plate System) and K080429 (PYRAMID® +4 Anterior Lumbar Plate System).
- Performance Data: States that the device was tested per ASTM F1717 for Static Compression Bending, Static Torsion, and Dynamic Compression Bending.
- Conclusion: The device is substantially equivalent to the predicate device based on overall technology characteristics and mechanical performance data.
Therefore, it is impossible to answer the user's request based on the provided document as it does not pertain to an AI/ML device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.