K Number

Device Name

H-LINK INTEGRATED ROD

Manufacturer

GLOBUS MEDICAL, INC.

Date Cleared

2008-01-03

(20 days)

Product Code

NKB MNH MNI

Regulation Number

888.3070

Intended Use

The H-LINK™ Integrated Rod, when used with 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 H-LINK™ Integrated Rod 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 ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

Device Description

The H-LINK™ Integrated Rod is a unitary implant that combines a t-connector with two rods. The rod diameter is 5.5mm or 6.35mm and the t-connector feature adjusts laterally. The 5.5mm H-LINK™ Integrated Rod can be used with a 5.5mm rod titanium posterior pedicle screw system, such as the REVERE™ Stabilization System. The 6.35mm H-LINK™ Integrated Rod can be used with a 6.35mm rod titanium posterior pedicle screw system, or with the PROTEX Stabilization System, which utilizes 6.0mm or 6.5mm rods. These implants are available in a variety of sizes to accommodate individual patient anatomy. H-LINK™ is intended for posterior use only and is positioned and secured into bilateral pedicle screws. H-LINK™ is composed of titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K061202, K040442, K052069

Reference Devices

K061202, K040442, K052069

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical properties and intended use of a spinal implant, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as an implant used to provide "immobilization and stabilization of spinal segments" as an "adjunct to fusion in the treatment of various acute and chronic instabilities or deformities." This directly indicates its use in treating medical conditions.

Diagnostic

The device is an implantable rod used in spinal fusion procedures to provide immobilization and stabilization, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a "unitary implant" composed of titanium alloy, which is a physical hardware component intended for surgical implantation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the H-LINK™ Integrated Rod is a surgical implant used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic device, not a diagnostic one.
Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed in the spine. This aligns with a surgical device, not a device used to test samples from the human body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

In summary, the H-LINK™ Integrated Rod is a surgical implant used for spinal stabilization, which falls under the category of a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The H-LINK™ Integrated Rod, when used with posterior pedicle screws, 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 socral 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 H-LINK™ Integrated Rod is intended for the 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 ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

Product codes

MNH, MNI, NKB

Device Description

H-LINK™ is composed of titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic, lumbar and socral spine, L5-S1 vertebra, lumbosacral spine and/or ilium. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K061202, K040442, K052069

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Summary

K073517

510(K) Summary: H-LINK™ Integrated Rod

| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 | | | JAN | - 3 2008 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-----|----------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory | | | | |
| Device Name: | H-LINK™ Integrated Rod | | | | |
| Classification: | Per 21 CFR as follows:
§888.3070 Pedicle Screw Spinal System
§888.3070 Spondylolisthesis Spinal Fixation Device System
Product Codes MNH, MNI, NKB.
Regulatory Class II and III, Panel Code 87. | | | | |
| Predicate(s): | Globus Medical REVERE™ Stabilization System | | | | |

K061202, SE date July 20, 2006 Globus Medical PROTEX® Stabilization System K040442, SE date May 20, 2004 K052069, SE date August 17, 2005 Product Codes MNH, MNI, NKB included Regulatory Class II and III, Panel Code 87.

Device Description:

Intended Use:

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.

Basis of Substantial Equivalence:

The H-LINK™ Integrated Rod is similar to predicate REVERE™ and PROTEX® Stabilization System implants system with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

JAN - 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Dr. Kelly J. Baker Director, Clinical Affairs & Regulatory 2560 General Armistead Ave. Audubon, PA 19403

Re: K073517

Trade/Device Name: H-Link™ Intergrated Rod Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI Dated: December 13, 2007 Received: December 14, 2007

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.

Page 2 - Dr. Kelly J. Baker

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use Statement

510(k) Number:

H-LINK™ Integrated Rod Device Name:

INDICATIONS:

In addition, the H-LINK™ Integrated Rod 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 ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109)

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

thumme E. Cuga

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________