Search Results

The MONARCH Spine 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System when used with pedicle screws 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 MONARCH Spine System Open and Closed Monoaxial Screws are designed to accept a 6.35mm diameter rod and are available in various lengths and diameters.
The MONARCH Spine System Open and Closed Hooks are designed to accept a 6.35mm rod and are available in a variety of geometries.
The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a medical device submission (K023438) for the MONARCH Spine System, but it does not contain acceptance criteria for device performance or a study demonstrating that these criteria have been met.

Instead, the document primarily focuses on:

• Device Description: What the MONARCH Spine System is, including its components (monoaxial screws, hooks) and the materials it's made from (ASTM F-136 implant grade titanium alloy).
• Intended Use/Indications for Use: The specific medical conditions and patient populations for which the device is intended (e.g., immobilization and stabilization of spinal segments for various instabilities and deformities, treatment of severe spondylolisthesis, degenerative disc disease).
• Predicate Devices: Reference to previously cleared MONARCH Spine System devices (K021335, K010576).
• Regulatory Classification: The classification names, regulation numbers, and regulatory class (Class III) for the device.
• FDA Clearance: An FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Statement on Performance Data: A brief, general statement under "PERFORMANCE DATA:" that "Performance data were submitted to characterize the MONARCH Spine System." However, the actual performance data, acceptance criteria, or a description of the study itself are not included in this summary.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document only states that performance data "were submitted" but does not detail what those data were or against what criteria they were judged.

Ask a specific question about this device