Search Results

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.

1. The Zodiac® Polyaxial Spinal Fixation System, when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine.

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity.

c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolithesis.

2. The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor and failed previous fusion (pseudoarthrosis).

3. The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving only autogenous bone graft

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolithesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

4. The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity.

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

The provided document, K081158 for the Zodiac® Polyaxial Spinal Fixation System, is a 510(k) summary for a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and mechanical performance. It does not contain information related to software-based AI/ML device performance or clinical studies with human participants that would typically evaluate acceptance criteria in the manner requested.

Therefore, I cannot provide the detailed information requested in points 1 through 9. The document focuses on mechanical performance and substantial equivalence to previously cleared spinal fixation systems, not on an algorithm's performance on medical imaging or clinical outcomes in the same way an AI/ML device would be evaluated.

Specifically, the document states:

• "The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device." This confirms the evaluation was mechanical, not clinical or AI/ML driven.
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This re-emphasizes the nature of the submission as a substantial equivalence claim for a physical medical device.

Therefore, the table and details requested about acceptance criteria, study design, expert ground truth, sample sizes (for test/training sets), adjudication methods, and MRMC studies are not applicable to the information provided in this 510(k) summary.

Ask a specific question about this device