The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Device Description

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

AI/ML Overview

The provided text is a 510(k) summary for the HILINE™ Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material characteristics. The summary explicitly states:

"Performance data demonstrate substantial equivalence to the predicate devices."

However, the provided text does not contain the detailed information required to fill out the table regarding acceptance criteria, specific device performance metrics, or study design details for clinical or AI-related performance evaluations. The "Performance Data" section solely mentions mechanical testing in accordance with ASTM F1798. There is no indication of a study involving human readers, ground truth establishment by experts, or any AI component.

Therefore, several sections of your request cannot be fulfilled based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
*Not specified*	Performance data demonstrate substantial equivalence to predicate devices (based on mechanical testing per ASTM F1798)

The document states that mechanical testing (static and dynamic tension, band pull-through, rod push-through, and static component torsion) was conducted in accordance with ASTM F1798, and that the performance data demonstrated substantial equivalence to the predicate devices. However, it does not specify the numerical acceptance criteria or the specific numerical results of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or human-involved test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC study was not done. The device description and performance data section do not mention any AI component or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm study was not done. The device description and performance data section do not mention any AI component.

7. The type of ground truth used: Not applicable. No ground truth for an AI algorithm or diagnostic performance study is mentioned. The "ground truth" relevant here pertains to the physical properties and performance of the device under mechanical stress, which are assessed through standardized mechanical testing (ASTM F1798).

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

April 20, 2023

Globus Medical Inc. Dr. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K230565

Trade/Device Name: HILINE™ Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: February 28, 2023 Received: March 1, 2023

Dear Jennifer Antonacci:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'neill -S

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230565

Device Name HILINETM Fixation System

Indications for Use (Describe)

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: HILINE™ Fixation System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Jennifer Antonacci, Ph.D.Group Manager, Regulatory Affairs
Date Prepared:	April 17, 2023
Device Name:	HILINETM Fixation System
Common Name:	Bone Fixation Cerclage, Sublaminar
Classification:	Per 21 CFR as follows:§888.3010 Bone Fixation CerclageProduct Code: OWIRegulatory Class: II, Panel Code: 87
PrimaryPredicate:	SILC® Fixation System (K133482)
AdditionalPredicates:	SILC® Fixation System (K172417)Implanet JAZZTM LOCK (K153348)Implanet JAZZTM CAP SP (K182771)Medicrea LigaPASSTM 2.0 (K213659)
ReferenceDevice:	CREOTM Stabilization System (K124058, K180210)

Purpose:

The purpose of this submission is to request clearance for the HILINE™ Fixation System.

Device Description:

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Indications for Use:

Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring . techniques;
. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis:
. Spinal degenerative surgery, as an adjunct to spinal fusions;
Use with a posterior spinal instrumentation construct when ligament . augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Performance Data:

Mechanical testing (static and dynamic tension, band pull-through, rod pushthrough, and static component torsion) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate devices.

Technoloqical Characteristics:

The HILINE™ Fixation System has similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Basis of Substantial Equivalence:

The HILINE™ Fixation System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate devices.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.