Search Results

The EDEN Spinal Fixation MIS System is intended to provide immobilization of the posterior, noncervical spine as an adjunct to fusion in skeletally mature patients 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, pseudarthrosis, and/or failed previous fusion.

The EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.

The purpose of this special 510(k) submission is to add MIS components and instruments to the previously cleared EDEN Spinal Fixation System. The EDEN Spinal Fixation MIS System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EDEN Spinal Fixation MIS System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI- 4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EDEN Spinal Fixation MIS System. The EDEN Spinal Fixation MIS System will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use. The orthopedic instruments are Class I, 510k exempt, and discussed here for informational purpose only.

This FDA 510(k) summary is for a spinal fixation system, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria, study data, expert ground truth, MRMC studies, and standalone algorithm performance used in the context of AI/ML devices is not applicable to this document.

The document discusses non-clinical tests based on various ASTM and ISO standards for spinal implants, focusing on mechanical properties and biocompatibility. It concludes substantial equivalence to a predicate device based on these engineering tests, not a clinical study involving human or AI interpretation of medical data.

Ask a specific question about this device