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The Endius® TiTLE™ Spinal Fixation 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™ Spinal Fixation 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, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Endius® TiTLE™ Spinal Fixation 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 Tumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius® TiTLE™ Spinal Fixation System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The nonpedicle 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), tumor, fracture, and previous failed fusion surgery.

The Endius® TiTLE™ Spinal Fixation 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.

This document, K021881, is a 510(k) Premarket Notification for a device modification, specifically for the Endius® TiTLE™ Spinal Fixation System. It does not describe an AI/ML powered device, nor any study proving the device meets acceptance criteria related to AI/ML performance.

The document primarily details:

• Device Name: Endius® TiTLE™ Spinal Fixation System
• Submission Type: Special 510(k) Premarket Notification for a device modification. This means the device is a modified version of a previously cleared device (predicate device K014090).
• Indications for Use: Specific spinal conditions (e.g., degenerative disc disease, spondylolisthesis, fracture, scoliosis, tumor, failed fusion) for which the device is intended.
• Device Description: It's a system made of titanium, including screws, rods, and connection components for posterior lumbar fusion procedures.
• Substantial Equivalence: The key argument for 510(k) clearance is that the modified device is substantially equivalent to its predicate device (Endius Spinal Fixation System: K014090).

Therefore, none of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is present in this document.

This document is a regulatory submission for a physical medical device (spinal fixation system), not a software or AI/ML product that would typically involve the types of performance criteria and studies outlined in your request.

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