Search Results

The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach.

The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic. Iumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondvlolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.

The system consists of implants and instruments. The implants consist of monoaxial and polvaxial pedicle screws of varying diameters and lengths, blockers, pre-contoured and straight Titanium alloy rods, transverse connectors of varying lengths, hooks, autostable hooks and axial and side-by-side connectors. All implants are made of titanium alloy and one commercially pure titanium component within the transverse connectors.

Re-usable surgical instruments are provided to facilitate placement of the implants.

In addition, the Instinct Java System is compatible with the transverse connectors currently cleared for the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java titanium alloy rods may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985. The system may also be used in combination with the Zimmer Spine Universal Clamp 5.5mm Ti implants. Axial and side-by-side connectors may be used with Nexlink 4.0 rods and Optima 6.0 rods.

The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion. This decision should be made based on the risk/benefit evaluation for each patient.

This document is a 510(k) summary for the Zimmer Spine Instinct™ Java® System, a spinal fixation system. It describes the device, its intended use, and its comparison to predicate devices for demonstrating substantial equivalence. The information provided heavily focuses on the mechanical and material equivalence of the device components rather than software-driven performance or AI.

Therefore, the requested information regarding acceptance criteria and studies related to an AI device's performance cannot be extracted from this document. The document describes a traditional medical device (spinal implant) and its regulatory clearance process based on substantial equivalence to existing devices, which typically involves mechanical testing and material compatibility, not studies of AI performance metrics like sensitivity, specificity, or reader studies.

No information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device is present in the provided text.

Ask a specific question about this device