The PROTEX™ Stabilization System, when used as a system, is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the PROTEX™ Stabilization System is intended for 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 lumbosacral spine and/or illium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the PROTEX™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the PROTEX™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Device Description

The PROTEX™ Stabilization System consists of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The implants are composed of titanium alloy as specified in ASTM F136 and F1295.

AI/ML Overview

This 510(k) pertains to a spinal stabilization system, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are specific to the evaluation of AI/ML device performance, is not applicable to this document.

The "PERFORMANCE DATA" section of the 510(k) summary (Section {1}) states:

"Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', September 27, 2000 is presented."

This indicates that the device's performance was evaluated through mechanical testing to ensure its structural integrity and functional characteristics meet established standards for spinal implants. These types of devices do not involve AI/ML components for diagnostic or predictive purposes, and thus do not have "acceptance criteria" in the context of sensitivity, specificity, AUC, or reader studies that would typically be associated with AI/ML medical devices.

The "BASIS OF SUBSTANTIAL EQUIVALENCE" (Section {1}) further clarifies that:

"The PROTEX™ Stabilization System implants are similar to the predicate Synthes USS and Click'X (K992739, K022949, K031175) thoracolumbar stabilization systems with respect to technical characteristics and performance."

This suggests that the device's acceptance criteria primarily revolve around demonstrating mechanical equivalence and adherence to the same design and material specifications as the predicate devices, as evaluated through established biomechanical testing protocols.

Therefore, I cannot provide a table of acceptance criteria and device performance, sample sizes for test sets, details on expert establishment of ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set relevant to AI/ML devices.

Summary

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510(K) Summary 111.

MAY 2 0 2004

50404/2
page 1 of 2

SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker

DEVICE NAME:

PROTEX™ Stabilization System

CLASSIFICATION:

Per 21 CFR as follows: $888.3050 Spinal Interlaminal Fixation Orthosis 5888.3060 Spinal Intervertebal Body Fixation Orthosis §888.3070 Pedicle Screw Spinal System §888.3070 Spondylolisthesis Spinal Fixation Device System Product Codes MNH, MNI, KWQ, KWP, NKB. Requlatory Class II. Panel code 87.

PREDICATE DEVICES:

Synthes Click'X: K992739, SE date February 8, 2000 Synthes USS: K022949, SE date March 24, 2003 Synthes Click'X Monoaxial System: K031175, SE date Nov 14, 2003 Product codes are MNH, MNI, KWQ, KWP, NKB.

DEVICE DESCRIPTION:

The implants are composed of titanium alloy as specified in ASTM F136 and F1295.

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510(k) Premarket Notification -- PROTEX™System

INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 is presented.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The PROTEX™ Stabilization System implants are similar to the predicate Synthes USS and Click'X (K992739, K022949, K031175) thoracolumbar stabilization systems with respect to technical characteristics and performance.

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Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human figures.

MAY 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kelly J. Baker, Ph.D. Project Manager, Quality Assurance and Regulatory Affairs Globus Medical, Inc. 303 Schell Lane Phoenixville, Pennsylvania 19460

Re: K040442

Trade/Device Name: PROTEX™ Stabilization System Regulation Numbers: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Names: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Codes: MNII, KWQ, MNI, NKB Dated: February 19, 2000 Received: February 20, 2004

Dear Dr. Baker:

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 classificd (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 -- Kelly Baker, Ph.D.

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,

Miriam C. Purves t

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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Indications for Use Statement II.

510(k) Number:	K040442
----------------	---------

PROTEX™ Stabilization System Device Name:

Indications:

The PROTEX™ Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in system, is imendou to provid an adjunct to fusion in the treatment of the following Skeletally mature pastabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the degenerative dioo diooao (condiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the PROTEX™ Stabilization System is intended for treatment of severe in addition, thesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature spondylollownomis (Groon by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a farlid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the PROTEX™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history (and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scollosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR §801.1	X Mirian L. Provost
(Division Sign-Off)	Over-The-Counter Use ______

Division of General, Restorative,
and Neurological Devices

510(k) Number	K040442
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Regulation Number and Section

N/A