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The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided text is a 510(k) summary for the ZPLATE-ATL™ Anterior Spinal Fixation System, which describes a medical device, not an AI or software device. Therefore, the questions related to acceptance criteria, study design, ground truth, and expert evaluation for AI performance are not applicable to this document.

The document focuses on:

• Product Description: "The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case."
• Indications for Use: Listing specific spinal conditions (degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fracture, neoplastic disease, unsuccessful previous fusion surgery, lordotic deformities, idiopathic thoracolumbar or lumbar scoliosis, deformity with deficient posterior elements, neuromuscular deformity with pelvic obliquity) for which the device can be used for "screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only."
• Substantial Equivalence: Stating that "Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself." This implies it's either a new version of an already cleared device or a direct claim of equivalence to a predicate without listing a different predicate upfront. The FDA letter confirms the FDA's finding of substantial equivalence to "devices marketed in interstate commerce prior to May 28, 1976."

Since this is a physical medical device and not an AI/software device, the questions regarding acceptance criteria and study design for AI evaluation cannot be answered from the provided text.

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