Search Results

The UNIMAX Pedicle Screw 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 thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 Pisharodi Surgicals, Inc. UNIMAX Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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,

When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the UNIMAX Pedicle Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The UNIMAX Pedicle Screw System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 UNIMAX Pedicle Screw System consists of pedicle screws (K014302) vertical, washers, nuts and horizontal plates. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is the Offset Horizontal Plate. Its purpose is to provide rigidity to the spinal construct similar to the horizontal plate cleared on K014302.

Here's a summary of the acceptance criteria and study information for the UNIMAX Pedicle Screw System, based on the provided 510(k) summary:

This submission (K024313) is for an additional component, the Offset Horizontal Plate, for the existing UNIMAX Pedicle Screw System (K014302). Therefore, the study focuses on demonstrating the substantial equivalence of this new component rather than a comprehensive study of the entire system.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail a "test set" in the context of clinical data or a large-scale algorithmic evaluation. The evaluation appears to be based on nonclinical (mechanical/bench) analysis. The sample size for this analysis is not stated explicitly but implies a sufficient number of tests to demonstrate equivalence.

Data provenance: Not applicable in the context of clinical data, as it's a nonclinical evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for this nonclinical evaluation would be established by engineering principles and material science standards (e.g., ASTM F136 conformance for titanium alloy), not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable, as this was a nonclinical mechanical analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was a nonclinical evaluation of a mechanical component, not an AI or diagnostic device requiring MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the nonclinical evaluation of the Offset Horizontal Plate's strength is based on engineering analysis and comparison to a predicate device's mechanical properties. The material conformance to ASTM F136 for titanium alloy (Ti-6Al-4V) also serves as a ground truth for material quality.

8. The Sample Size for the Training Set

Not applicable, as this is a mechanical device, not an AI or machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Ask a specific question about this device