When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the JAVA Spinal Fixation System is also 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The Spine Next SHIRAZ JAVA Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after development of a solid fusion mass. The system includes screws, rods, and connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

AI/ML Overview

This document, K031265, describes the Spine Next SHIRAZ JAVA Spinal Fixation System. However, it does not contain the information needed to fill out the table regarding acceptance criteria and device performance as it pertains to AI/ML or diagnostic performance. This submission is for a traditional medical device (spinal fixation system), not a software as a medical device (SaMD) or an AI-powered diagnostic tool. Therefore, the requested information on AI/ML-related performance metrics, such as sample size, ground truth, expert adjudication, or MRMC studies, is not applicable or available in this document.

The document primarily focuses on:

Device Description and Materials: The system includes screws, rods, and connectors made from Titanium Alloy (Ti6A4V).
Indications for Use: Treatment of severe spondylolisthesis and various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine as an adjunct to fusion.
Performance Data: Biomechanical testing was performed in accordance with ASTM F1717 and ASTM F1798. These are standards for mechanical properties of spinal implant systems, not for diagnostic accuracy or algorithmic performance.
Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices (Moss Miami K021880).

Therefore, I cannot provide the requested information for acceptance criteria and study proving AI device meets acceptance criteria, as this device is a physical spinal fixation system and not an AI-driven one.

Summary

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031265 14

OCT - 9 2003

510(k) SUMMARY

SUBMITTED BY

Diane Johnson On behalf of Spine Next America 4720 Salisbury Road Suite 135 Jacksonville, FL 32256

April 14, 2003 Date Submitted:

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Trade/Proprietary Name:

Common/Usual Name: Classification Name:

Spine Next SHIRAZ JAVA Spinal Fixation System Pedicle Screw System Orthosis, Spondylolisthesis Spinal Fixation or Orthosis, Spinal Pedicle Fixation

PREDICATE DEVICE

Moss Miami [reference 510(k) K021880 cleared June 26, 2002]

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

INDICATIONS FOR USE

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by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

PERFORMANCE DATA

Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

Spine Next SA c/o Ms. Diane Johnson Director, Regulatory Affairs Spine Next America Corporation 104 Greenwood Creek Road Queenstown, MD 21658

Re: K031265

Trade/Device Name: SHIRAZ JAVA Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3070, Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: July 24, 2003 Received: July 25, 2003

Dear Ms. Johnson:

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 - Ms. Diane Johnson

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/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark A. Milliken

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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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Spine Next SHIRAZ JAVA Spinal Fixation System

Indications for Use:

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (PER 21 CFR 801.109) OR

Over-The-Counter Use

Optional Format 1-2-96

Mark N. Milken

Divisio ign-Off Division General. Restorative and Neurological Devices

510(k) Number K031265

Regulation Number and Section

N/A