Search Results

The PASS LP Spinal Systems include a pedicle system intended to provide immobilization 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:

• Fracture
• Dislocation
• Failed previous fusion (Pseudarthrosis)
• Spinal stenosis
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Spinal deformities such as scoliosis or kyphosis
• Loss of stability due to tumors

The PASS LP Spinal Systems are 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 fate the attainment of a solid fusion.

The PASS LP also includes hooks and sacral/ilac screws indicated for degenerative disc disease (DD) 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine. The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537. The purpose of this submission is to add to the PASS LP range the new component: 'Patient Specific Rod'. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the design defined by the surgeon only, specific to a unique patient.

This document describes a 510(k) premarket notification for the PASS LP Spinal System - Patient Specific UNiD Rods. It does not contain information about an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets those criteria, as these are typically relevant for AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to a predicate device (PASS LP Spinal System, K123138) based on intended use, materials, design, and mechanical safety/performance for a spinal implant.

Specifically, the "Non-clinical Test Summary" (Section 7) mentions that static and dynamic compression and static torsion tests were conducted on two worst-case UNiD Rods (extreme lordosis and kyphosis) following ASTM F1717. However, it does not provide acceptance criteria or specific performance data from these tests. It also states that no tests were conducted following ASTM F1798 because the UNiD Rods have the same diameters as the already cleared PASS LP rods, implying similar mechanical performance for connection components. The document explicitly states "No clinical studies were performed" (Section 8).

Ask a specific question about this device