(63 days)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNALOK CLASSIC™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNALOK CLASSICTM Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar system, the DYNALOK CLASSIC™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The DYNALOK CLASSIC™ Spinal System consists of a variety of shapes and sizes of plates, bolts, screws, washers, nuts, spacers, CROSSLINK® Plates, and connecting components. The DYNALOK CLASSIC™ Spinal System components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Additionally, the DYNALOK CLASSIC™ Spinal System may be used in conjunction with TSRH ® Spinal System, CD HORIZON ® Spinal System, and TENOR™ Spinal System.
DYNALOK CLASSIC™ Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. Never use stainless steel and titanium implant components in the same construct.
The purpose of this submission is to add closed rod/bolt connectors, TSRH® Spinal System set screws and additional DYNALOK CLASSIC™ bolt lengths to the existing system.
This document is a 510(k) summary for the DYNALOK CLASSIC™ Spinal System, a medical device for spinal fixation. It details the device description, indications for use, and a statement of substantial equivalence to predicate devices, but does not describe an AI/ML powered device or a study comparing its performance against acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not found in the provided text.
The document states: "Functionality & Safety Testing: A Risk Analysis was performed on the DYNALOK CLASSIC™ Spinal System and is included in this submission. The subject DYNALOK CLASSIC™ devices were found to be substantially equivalent to the DYNALOK CLASSIC™ Spinal System." This indicates that the regulatory approval was based on demonstrating equivalence to an already approved device, likely through engineering tests and risk analysis, not through clinical performance metrics against defined acceptance criteria that would typically be reported for an AI/ML device.
§ 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.