(34 days)
The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; survatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are monded for the formities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to when used as a vertebrar body replaceming surgical correction and stabilization of the spine. The be used in corpectonly procedures to the under spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Specifically, DASID - Vertenal Booy of lates, Multi-Axial Screws, or Fixed Angle Screws. Dallek DASIS - Amerior Theraceral Body Spacers are intended to be used with bone graft.
Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Nota Denc. The Drive - The BASIS™ Anterior Cervical Plates are intended for anterior cervical intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only.
The BASISTM Spinal System consists of a variety of shapes and sizes of hooks, screws, bolts, nuts, plates, and vertebral body spacers, as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.
BASIS™ hooks are intended for posterior use only.
The BASIS™ Spinal System implant components are made from medical grade titanium alloy. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.
BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the BASIS™ Anterior Thoracolumbar Plate, the BASIS™ Multi-Axial Screws, or the BASIS™ Fixed Angle Screws must be used with the BASIS™ Vertebral Body Spacers.
To achieve best results, do not use any of the BASIS™ components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic implants, none of the BASIS™ components should ever be reused under any circumstances.
The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System.
The provided document is a 510(k) summary for the BASIS™ Spinal System - Crosslink® Plates. This type of document is a premarket notification to the FDA for medical devices and typically does not contain detailed study information, acceptance criteria, or performance data in the way a clinical trial report or a comprehensive engineering study would for a new AI/software device.
Instead, 510(k) submissions demonstrate substantial equivalence to a legally marketed predicate device. This usually involves comparing device characteristics and, in some cases, non-clinical bench testing or animal studies, rather than extensive human clinical trials with performance metrics like sensitivity, specificity, or reader studies.
The document states:
- "The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System."
- "Components to be substantially equivalent to EQUATION™ Fixation System Components previously cleared in K013962."
Therefore, the requested information about acceptance criteria and a study proving device performance in the context of an AI/software device is not available in the provided text.
The document focuses on:
- Product Description: Details of the BASIS™ Spinal System components (hooks, screws, bolts, nuts, plates, vertebral body spacers), materials (medical grade titanium alloy), and general usage guidelines (e.g., prohibition of reuse, not mixing with other systems).
- Indications For Use: Specifies the medical conditions and anatomical regions for which the BASIS™ Spinal System is intended (spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion, vertebral body replacement).
- Substantial Equivalence: States that the components are substantially equivalent to the EQUATION™ Fixation System Components (K013962). This is the primary "proof" for a 510(k) submission – demonstrating that the new device is as safe and effective as a legally marketed predicate device, not necessarily meeting specific performance criteria that would be established for an AI algorithm.
In summary, this document is for a spinal implant system, not a software/AI device, and therefore does not contain the specific information requested.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.