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The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:

• The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The intended use and indications when used as a Pedicle Screw Spinal System are:

• The UCR Spinal System is a pedicle screw system 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 neurological impairment,
• fracture,
• dislocation,
• scoliosis,
• kyphosis,
• spinal tumor, and
• failed previous fusion (pseudoarthrosis).

Hook Spinal System indications are limited to T1-L5 and are:

• degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic),
• spinal stenosis,
• spondylolisthesis,
• spinal deformities (scoliosis, kyphosis, and/or lordosis),
• fracture,
• pseudarthosis,
• tumor resection, and/or
• failed previous fusion.

The UCR Spinal System hooks include titanium alloy laminar and pedicle hook assemblies. The laminar hooks will be available in widths of 5.5mm and 7.0mm and in five heights that range from 5.0 to 10.0mm. The pedicle spinal hooks will be available in widths of 7.5mm and 9.0mm and in four heights that range from 5.0 to 9.5mm. The laminar hooks will also be available in offset versions. The hook assembly is comprised of a hook body, temporary fixation pin, cap, and set screw. The hook assembly is designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The UCR Spinal System hooks also utilize a variety of instruments to assist in placement of the devices. These instruments include a hook holder, hook inserter, temporary fixation pin inserter, power rod gripper, and a rocker. The instruments will be fabricated from stainless steel and Radal. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The provided text describes the UCR Spinal System, focusing on its intended use, description, and technological characteristics compared to predicate devices. It clearly states that the device is "substantially equivalent" to existing predicate devices.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics.

The text is a 510(k) summary, which is typically a premarket notification to the FDA. For devices like the UCR Spinal System, substantial equivalence to a legally marketed predicate device is the primary pathway for clearance, rather than extensive performance studies with acceptance criteria as would be required for a novel, high-risk device or a diagnostic algorithm.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on intended use, design, dimensional specifications, and material to predicate devices, rather than presenting a performance study against specific acceptance criteria.

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