The PROTEX™ Stabilization System, when used as a posterior pedicle screw 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 illum 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. AccuRods are intended for posterior use with polyaxial and monoaxial screws 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

The PROTEX™ Stabilization System is a medical device designed to provide immobilization and stabilization of spinal segments. The provided text indicates that the device's performance was evaluated through mechanical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What it needed to meet)	Reported Device Performance (How it met the criteria)
Mechanical performance in accordance with ASTM F1717 standard requirements	Mechanical testing in accordance with ASTM F1717 was conducted.
Substantial equivalence to predicate device PROTEX™ (K040442) components	The additional components are similar to the predicate PROTEX™ (K040442) components with respect to technical characteristics and performance.

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

The provided document describes mechanical testing as the performance data.

Sample Size for the Test Set: Not explicitly mentioned for the mechanical testing. ASTM F1717 specifies various tests (e.g., static and fatigue compression bending, static torsion, fatigue torsion, static cantilever bending). The sample size for each test would typically be defined within the ASTM standard or by the manufacturer based on statistical validity requirements, but this information is not provided in the summary.
Data Provenance: Not explicitly stated. Mechanical testing is typically conducted in a laboratory setting, so it is prospective data focused on material and design performance. The country of origin for the testing itself is not mentioned, but the manufacturer is based in Phoenixville, PA, USA.

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

This type of information is not applicable to mechanical testing performed for device performance. Mechanical testing relies on established engineering standards (like ASTM F1717) and objective measurements, not expert human interpretation for "ground truth."

4. Adjudication Method for the Test Set

This is not applicable to the mechanical testing described. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective criteria, which is not the case for material property and structural integrity testing of a medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not conducted. The performance data presented focuses on mechanical testing of the device itself, not on human reader performance with or without AI assistance. This device is a surgical implant, not an AI-powered diagnostic or assistive tool.

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

No, a standalone algorithm performance study was not conducted. This device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for performance validation was adherence to established mechanical testing standards (ASTM F1717). This standard defines objective criteria for mechanical properties, strength, and fatigue life for spinal implant assemblies. The "ground truth" is whether the device can withstand the specified forces and cycles without failure, as defined by the standard.

8. The Sample Size for the Training Set

This information is not applicable. Mechanical testing for medical devices does not typically involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are validated through engineering principles and testing against established standards.

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

This is not applicable for the reasons stated in point 8.

Summary

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Special 510(k) -- PROTEX™ System AUG 17 2005

510(K) Summary lll.

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 §888.3060 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. Requiatory Class III Panel code 87.

PREDICATE DEVICES:

PROTEX™ Stabilization System K040442, SE date May 20, 2004

DEVICE DESCRIPTION:

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

Page 1 of 2

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INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with ASTM F1717 was conducted to evaluate performance, as a basis for substantial equivalence.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The additional components are similar to the predicate PROTEX™ (K040442) components with respect to technical characteristics and performance.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2005

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

Re: K052069

Trade/Device Name: PROTEX™ Stabilization System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWP, KWQ, MNH, MNI, NKB Dated: July 29, 2005 Received: August 8, 2005

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 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 - Kelly J. Baker, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter valification. The FDA finding of substantial equivalence of your device to a legally premated notificated 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 n you t the Office of Compliance at (240) 276-0120. 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 other general miles manager 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/industry/support/index.html.

Sincerely yours,

Mark N. Mellon

Mark N. Melkerson for Acting 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 ll.

510(k) Number:

Image /page/4/Picture/3 description: The image shows a handwritten string of characters, "K052069". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the numbers being slightly rounded.

PROTEX™ Stabilization System Device Name:

Indications:

The PROTEX™ Stabilization System, when used as a posterior pedicle screw rne i NOTEX - Oldbilization and stabilization and stabilization of spinal segments in system, is intonood to provin an adjunct to fusion in the treatment of the following Skelctally mature pations as an deformities of the thoracic, lumbar and sacral spine: acute and onforms metable fined as discogenic back pain with degeneration of the degenerative aloo aloodoo (combiagraphic 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 in addition, the F NOT (STS) vertebra in skeletally mature SpondylolistinGlo (Grace o autogenous bone graft, having implants attached to the putteries rooorning labilor ilium with removal of the implants after attainment of a famoosation. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

OR Prescription Use × (Per 21 CFR $801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

oncurrence of CDRH, Office of Device Evaluation (ODE) Division of General. Restorative, and Neurological Devices

510(k) Number K052069

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.