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The MediRod Pedicle Screw System, with or without MIS instrumentation, is 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 thoracic, lumbar. and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the MediRod Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the MediRod Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MediRod Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws and rods manufactured from titanium alloy. All the components are available in a variety of sizes to match more closely the patient's anatomy.

This document is a 510(k) summary for the "MediRod Pedicle Screw System." It does not describe a study involving device performance metrics, accuracy, or human reader involvement in the context of AI or diagnostic systems. Instead, this document focuses on the mechanical performance testing of a physical medical device (pedicle screws) to demonstrate substantial equivalence to predicate devices for FDA clearance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, as typically applied to AI/diagnostic devices, is not available or applicable in this document.

The document states:

• Performance Testing: "Static and dynamic testing of the MediRod Pedicle Screw System was performed in accordance with ASTM F1717 (static and dynamic compression bending, and static torsion testing) and ASTM F1798 (static flexion-extension testing)."
• Conclusion: "Results of the testing demonstrate the substantially equivalent mechanical performance of the subject device."

This indicates that the acceptance criteria are based on meeting the standards set forth in ASTM F1717 and ASTM F1798 for mechanical properties, and the study "proves" the device meets these criteria by demonstrating substantial equivalence in mechanical performance to legally marketed predicate devices. However, no specific numerical acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the text.

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