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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma®-LP Spinal System is indicated as an adjunct to fusion for the following indications:

• Degenerative disc disease (discogenic pain with degeneration of the disc confirmed by history and radiographic studies);
• Degenerative spondylolisthesis with objective evidence of neurologic impairment:
• Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; ●
• Fracture; ●
• Dislocation:
• . Scoliosis:
• Kyphosis: .
• Spinal tumor: .
• Failed previous fusion (pseudarthrosis). ●

The Erisma®-LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The Erisma®-LP system is composed of rods fixed on the spine with pedicle screws. The Erisma®-LP includes monoaxial and polyaxial screws cannulated or not and monoaxial and polyaxial screws with or without breaking tabs, as well as a transverse link which connects two rods altogether.

The implants used in the Erisma®-LP system are made of ISO 5832-3 or ASTM F136 medical grade titanium alloy.

The Erisma®-LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21CFR 888.4540.

This document is a 510(k) summary for the Erisma®-LP Spinal Fixation System. It describes a medical device, specifically a pedicle screw spinal system.

Based on the provided text, the Erisma®-LP Spinal Fixation System is a mechanical device, not an AI/software device. Therefore, a discussion of acceptance criteria and studies in the context of AI/software device performance, ground truth, and human reader studies is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of:

• Intended Use and Indications for Use: These are the same as the cleared Erisma®-LP system.
• Technological Characteristics: The modified device has small differences (addition of breaking tabs, improved polyaxial screw assembly fixation strength, change in screw threading) that are stated not to raise new safety or effectiveness concerns and are present in reference devices.
• Performance Data (Bench Testing):
  • Dynamic ASTM F1717-15 testing
  • Pull-Out ASTM F543 testing

The information typically requested for AI/software device performance (such as a table of acceptance criteria vs. reported performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance) is not part of this submission for a hardware medical device.

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