Search Results

The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally 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 TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) 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, pseudarthrosis; and failed previous fusions in skeletally mature patients.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize 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 TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for additional stability. The subject TriALTIS™ System implants are comprised of Titanium alloy conforming to ASTM F136 and Nitinol conforming to ASTM F2063.

The provided FDA 510(k) clearance letter and summary for the TriALTIS™ Spine System do not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-driven medical device.

The document describes a spinal fixation system, which is a physical implant, not a software or AI-driven diagnostic or treatment device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 5 explicitly states:

• "The TriALTIS® Spine System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', specifically axial and torsional grip testing and flexion-extension testing."
• "Clinical testing is not applicable."

Therefore, the requested information regarding acceptance criteria, reported device performance (in terms of AI metrics), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found for AI/software devices, is not present in this document. This submission pertains to a traditional physical medical device.

Ask a specific question about this device