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.

Device Description

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.

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Mechanical strength	Analysis indicates that the offset horizontal plate is as strong as the predicate device (previous horizontal plate for UNIMAX Pedicle Screw System cleared on K014302).

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.

Summary

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510(k) Summary

AUG 2 9 2003

K024313
page 1 of 2

Date May 6, 2003

Submitter Pisharodi Surgicals, Inc.

942 Wildrose Lane Brownsville, TX 78520

Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Trade name UNIMAX Pedicle Screw System Horizontal Offset Plate

Common name Posterior spine system

Classification name Spondylolisthesis Spinal Fixation Device System - class II Pedicle Screw Spinal System - class II 888.3070 (per 21 CFR section)

Indications for Use

Equivalent Device

This additional component is equivalent to the previous horizontal plate for the UNIMAX Pedicle Screw System in indications, usage and materials.

Device Description

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. .

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All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

age of

Summary Nonclinical Tests

Analysis indicates that the offset horizontal plate is as strong as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of three stylized lines that resemble an eagle or bird in flight. The logo is black and white.

AUG 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pisharodi Surgicals, Inc. c/o Mr. J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, TX 78681

Re: K024313

Trade/Device Name: UNiversal MultiAXis (UNIMAX) Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: July 31, 20003 Received: August 1, 2003

Dear Mr. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html

Sincerely yours,

Mark A. Millican

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

page 1 of 1

INDICATIONS / INTENDED USE STATEMENT

024313

510(k) Number: K014302 (Regulatory Number: 21 CFR 888.3070)

Device Name: UNiversal MultiAXis (UNIMAX) Pedicle Screw System

Indications / Intended Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken
Division Sign-Off

Restorative

510(k) Number K024313

Regulation Number and Section

N/A