Search Results

The Endius® TITLE 2™ Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Endius® TITLE 2™Polyaxial 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Endius® TITLE 2™ Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius® TITLE 2™ Polyaxial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

The Endius® TITLE 2™ Polyaxial Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.

The provided text is a 510(k) summary for the Endius® TITLE 2™ Polyaxial Spinal System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a study against acceptance criteria for algorithm performance.

Therefore, the requested information regarding acceptance criteria, study details (sample size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set), and effect size cannot be extracted from the provided text.

The 510(k) summary outlines the device description, indications for use, and claims substantial equivalence to a previously cleared device (Endius TiTLE Spinal Fixation System: K021881). It does not contain information about clinical performance studies with specific statistical acceptance criteria for a new device's performance against a defined ground truth, nor does it include details on AI/algorithmic performance or human reader studies.

In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a clinical study report of a device's performance against pre-defined acceptance criteria.

Ask a specific question about this device