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The EXPEDIUM, VIPER, and VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM, VIPER, and VIPER2 Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® and VIPER® and VIPER® 2 Spine Systems consist of titanium rods, pedicle screws, connectors, hooks, and extended tab implants, which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain implants will be packaged in sterile multi-packs for customer convenience.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided 510(k) summary, there is no performance data or studies provided to establish acceptance criteria for a device's performance. This submission is for modifications to an existing spinal system (EXPEDIUM®, VIPER®, and VIPER2® Spine Systems) where the primary change is the sterilization method.

The summary explicitly states: "Performance data is not provided in this submission."

Therefore, I cannot populate the requested table or answer the specific questions related to performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement because this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices based on identical design, materials, indications, and technology, with the only modification being the terminal sterilization method via gamma radiation. In such submissions, the FDA typically accepts the existing safety and effectiveness profile of the predicate device if the changes are deemed not to alter these fundamental aspects.

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