HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When the HEDRON IC™ Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.

Device Description

HEDRON™ Cervical Spacers (HEDRON CTM and HEDRON ICT™) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRON ICT™ Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON ICT™ Plate-Spacer, a stand-alone cervical interbody fusion device. HEDRON™ Spacers are additively manufactured from titanium alloy, as specified in ASTM F3001.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (HEDRON™ Cervical Spacers), which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data. It does not describe an AI medical device or a clinical study that establishes acceptance criteria and proves the device meets those criteria from an AI performance perspective.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance for an AI model, as this document is not about an AI medical device.

The document discusses:

Device Name: HEDRON™ Cervical Spacers
Intended Use: Interbody fusion devices for cervical spine
Mechanical Testing: Static and dynamic compression, torsion, compression-shear, subsidence, and expulsion in accordance with specific ASTM standards and FDA guidance.
Basis of Substantial Equivalence: Similar technological characteristics (design, intended use, material composition, sizes) to predicate devices.

However, none of this relates to AI performance metrics, ground truth establishment, expert adjudication, or MRMC studies for AI devices.

Summary

{0}------------------------------------------------

September 17, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Globus Medical Inc. Kelly Baker, PhD Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K191243

Trade/Device Name: HEDRON™ Cervical Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: September 13, 2019 Received: September 16, 2019

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. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,

for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191243

Device Name HEDRON™ Cervical Spacers

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary: HEDRON™ Cervical Spacers

Company:	Globus Medical Inc.
	2560 General Armistead Ave.
	Audubon, PA 19403
	610-930-1800

Contact: Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
May 8, 2019 Date Prepared:

Device Name: HEDRON™ Cervical Spacers

Common Name: Interbody Fusion Device

Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code(s): ODP, OVE Regulatory Class: II, Panel Code: 87
Primary Predicate: PATRIOT® COLONIAL Spacers (K173722)

Other Predicates:	COALITION AGX® (K142218, K173115)REVEL™ Spacers (K180909)
Reference
Device:	NeoFuse Ti3D Cervical Interbody (K170318)

Purpose:

The purpose of this submission is to request clearance for HEDRON™ Cervical Spacers.

Device Description:

Indications for Use:

{4}------------------------------------------------

radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

When the HEDRON ICTM Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON ICTM Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implant. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws.

Performance Data:

Mechanical testing (static and dynamic compression, torsion and compressionshear, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.

Technoloqical Characteristics:

Subject implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.

Basis of Substantial Equivalence:

Subject interbody devices have 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 devices to the predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.