Search Results

The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization 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 and VIPER Spine Systems are 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 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); 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 for posterior noncervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER Spine System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER Spine Systems are intended to be used with autograft. Pediatric pediatic pedicle screw fixation is limited to a posterior approach.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The purpose of this premarket notification is to obtain market clearance of packaged sterile VIPER PRIME Screws. VIPER PRIME Screws with Fenestrations and EXPEDIUM Verse Screws with Fenestrations. These devices are to be provided sterile via gamma radiation.

The VIPER PRIME Screws are designed to facilitate a posterior percutaneous approach with minimally invasive surgery (MIS) instrumentation. The VIPER PRIME Screws are intended for use with existing components of the VIPER system to generate a posterior construct to provide immobilization and stabilization of spinal segments as an adjunct to fusion.

The VIPER PRIME Screws with Fenestrations and the EXPEDIUM Verse Screws with Fenestrations are intended for use with existing components of the VIPER and EXPEDIUM Verse system to generate a posterior construct to provide immobilization and stabilization of spinal segments. The VIPER PRIME Screws with Fenestration and the EXPEDIUM Verse Screws with Fenestrations are designed with a cannulation through the screw shank and fenestrations and may be used in conjunction with, or without, CONFIDENCE High Viscosity Spinal Cement in accordance with the indications for use specified below.

The provided document is a 510(k) summary for medical devices (pedicle screws) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/ML performance.

The document primarily focuses on establishing "substantial equivalence" of new versions of pedicle screws (VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations) to previously cleared predicate devices. The key change highlighted is that the subject devices will be terminally sterilized via gamma radiation, while the design, materials, indications, and technology remain identical to the predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text. There are no acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance mentioned in the document. This type of submission is for mechanical devices and not for AI/ML-driven diagnostics or assistive tools.

Ask a specific question about this device