(29 days)
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at 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; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia Titanium Spinal System.
The Xia® Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). The components are manufactured from Titanium material (Ti alloy and CP Titanium). This submission is intended to address a line extension to Xia® Spinal System. The line extension includes a new range of offset and rod to rod Titanium alloy connectors.
This 510(k) Premarket Notification (K052181) describes a line extension to the Xia® Spinal System. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics, statistical analysis, or comparison to a pre-defined threshold.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:
- Technological Comparison: Stating that the subject components (new range of offset and rod-to-rod Titanium alloy connectors) share the "same intended use, material, and basic design concepts" as the predicate Xia Spinal System (K013823).
- Mechanical Testing: Mentioning that mechanical testing "demonstrated comparable mechanical properties to the predicate device." However, no specific data, acceptance criteria for this testing, or detailed study methodology are provided in this summary.
Therefore, I cannot provide the requested information in the table or answer the specific questions related to acceptance criteria, sample sizes, ground truth, expert opinions, or comparative effectiveness studies based on the provided text. This type of 510(k) summary typically includes a high-level overview and directs the reviewer to the full submission for detailed testing results.
§ 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.