The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

Integrity Implants' FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted via a transforaminal (TLIF) or posterior (PLIF) approach, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FlareHawk Interbody Fusion System, based on the provided FDA 510(k) summary:

This device is an interbody fusion system, and the provided document is an FDA 510(k) summary. For this type of device, the "acceptance criteria" are typically related to mechanical performance and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than a diagnostic performance metric (like sensitivity/specificity) seen in AI/imaging devices. The "study" refers to non-clinical bench testing. There is no mention of an AI component or clinical studies in this submission document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Standard / Characteristic	Acceptance Criteria (Implicit from "in accordance with" and "meets")	Reported Device Performance (Implicitly, the device met these criteria for substantial equivalence)
Coating Characterization & Integrity	Stereological Assessment	In accordance with ASTM F1854	Device met requirements per ASTM F1854
	Static Shear Strength	In accordance with ASTM F1044	Device met requirements per ASTM F1044
	Static Tensile Strength	In accordance with ASTM F1147	Device met requirements per ASTM F1147
	Abrasion Resistance	In accordance with ASTM F1978	Device met requirements per ASTM F1978
	Wear Debris & Particle Characterization	In accordance with ASTM F1877	Device met requirements per ASTM F1877
Finished Device Mechanical Testing	Static Axial Compression	In accordance with ASTM F2077	Device met requirements per ASTM F2077
	Dynamic Axial Compression	In accordance with ASTM F2077	Device met requirements per ASTM F2077
	Static Compression Shear	In accordance with ASTM F2077	Device met requirements per ASTM F2077
	Dynamic Compression Shear	In accordance with ASTM F2077	Device met requirements per ASTM F2077
Biocompatibility	Cytotoxicity Testing	In accordance with ISO 10993-5	Device met requirements per ISO 10993-5
	Biocompatibility Assessment	In accordance with ISO 10993-1	Device met requirements per ISO 10993-1

Comment: The document states that integrity implants has conducted these tests "in support of this premarket notification submission" and concludes that the device "demonstrates substantial equivalence to legally marketed predicate devices, and any differences... do not impact the safety and effectiveness." This implicitly means the device met the acceptance criteria for these tests. Specific numerical performance results are not provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in terms of number of devices or test repetitions. For bench testing, samples are typically representatives of the manufacturing process.
Data Provenance: The tests were non-clinical bench performance tests, meaning they were conducted in a lab environment on the device itself, not on patient data or in a clinical setting. Therefore, "country of origin of the data" and "retrospective or prospective" do not apply in the usual sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device for implantation, and the "ground truth" for its performance is established through adherence to engineering standards (ASTM, ISO) and laboratory measurements, not through expert human interpretation of data for diagnostic purposes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human experts interpreting data. This document describes bench testing against engineering standards.

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

Not applicable. This is not an AI-assisted diagnostic device, nor does the submission mention an AI component. It is an implantable intervertebral fusion system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For mechanical testing: Engineering standards (ASTM F2077, F1044, F1147, F1978, F1854, F1877) and laboratory measurements of physical properties.
For biocompatibility: ISO standards (ISO 10993-1, ISO 10993-5) and laboratory biological assessments (e.g., cytotoxicity assays).

8. The sample size for the training set

Not applicable. This refers to an implantable medical device, not a machine learning model. There is no "training set" in this context.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned or relevant to this device type.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

September 23, 2020

Integrity Implants Inc. Ms. Lauren Kamer Senior Director of Regulatory and Clinical Affairs 354 Hiatt Drive Palm Beach Gardens, Florida 33418

Re: K201367

Trade/Device Name: FlareHawk® Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 18, 2020 Received: August 20, 2020

Dear Ms. Kamer:

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

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

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); 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,

Brent Showalter, Ph.D. 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

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

Indications for Use

510(k) Number (if known)

K201367

Device Name FlareHawk Interbody Fusion System

Indications for Use (Describe)

The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectorny. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

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

X 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 - K201367

FlareHawk Interbody Fusion System

August 18, 2020

I.	Company:	Integrity Implants Inc.354 Hiatt DrivePalm Beach Gardens, FL 33418Telephone: 561-529-3861
II.	Contact:	Lauren KamerSenior Director of Regulatory and Clinical Affairs
III.	Proprietary Trade Name:	FlareHawk® Interbody Fusion System
IV.	Common Name:	Intervertebral Body Fusion Devicewith Bone Graft, Lumbar
V.	Classification Name:	Intervertebral Body Fusion Device (21 CFR 888.3080)
	Class:	II
	Product Code:	MAX

VI. Product Description

K201367 510k Summary Page 1 of 4

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

to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.

VII. Indications for Use

FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

VIII. Summary of Technological Characteristics

The subject FlareHawk Interbody Fusion System has substantially similar fundamental scientific technology as the predicate FlareHawk Interbody Fusion System.

Like the predicate FlareHawk Interbody Fusion System, the shell component of the subject FlareHawk Interbody Fusion System implants is a rectangular frame that is inserted into the disc space in a non-expanded form, with subsequent in-situ expansion resulting from the insertion of the shim component. The shell component is manufactured from PEEK per ASTM F2026, and incorporates an integrated core manufactured from titanium alloy per ASTM F136, and tantalum markers per ASTM F560 for imaging purposes. The shell component features a bulleted nose designed to facilitate ease of insertion, as well as directional teeth on its superior and inferior surfaces to resist expulsion. Like the

{5}------------------------------------------------

predicate FlareHawk Interbody Fusion System, the shim component of the subject FlareHawk Interbody Fusion System implants has a tapered front end that inserts into and expands the shell component to the desired height and lordosis. The shim is manufactured from titanium alloy per ASTM F136 and the shims are color anodized by size. The shim locks to both the shell core and the posterior of the shell when the implant is deployed.

The subject FlareHawk Interbody Fusion System shell components are coated with Grade 2 commercially pure titanium that meets the chemical composition requirements of ASTM F67.

IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

To demonstrate the substantial equivalence of the subject FlareHawk Interbody Fusion System to legally marketed predicate devices, FlareHawk Interbody Fusion System, K182114 (SE 01/07/2019), is used as the primary predicate device. Integrity Implants' FlareHawk Interbody Fusion System, K183184 (SE 04/03/2019), is also used as a predicate for this submission.

Additionally, the following devices are being used as additional predicate devices for this submission to demonstrate that commercially pure titanium coatings are not new and currently exist on other legally marketed lumbar interbody fusion devices:

SpineFrontier Lumbar Interbody Fusion Device System (K142504, SE 05/13/2015) .
Tyber Medical Intervertebral Body Fusion Device (K130573, SE 09/30/2013) ●
Alphatec Spine Battalion Universal Spacer System (K143740, SE 05/22/2015) .
. Octane Straight Intervertebral Fusion Device, Ti Coated (K150152, SE 05/11/2015)

X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted

Integrity Implants has conducted bench performance testing in support of this premarket notification submission as follows:

. Coating Characterization and Coating Integrity Testing
- o Stereological Assessment in accordance with ASTM F1854 (as appropriate)
- o Static Shear Strength in accordance with ASTM F1044

{6}------------------------------------------------

o Static Tensile Strength in accordance with ASTM F1147
Abrasion Resistance in accordance with ASTM F1978 o
Wear Debris and Particle Characterization in accordance with ASTM F1877 o
Finished Device Mechanical Testing
- o Static Axial Compression in accordance with ASTM F2077
- o Dynamic Axial Compression in accordance with ASTM F2077
- o Static Compression Shear in accordance with ASTM F2077
- Dynamic Compression Shear in accordance with ASTM F2077 o

Integrity Implants has conducted a biocompatibility assessment in accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.

XI. Conclusions Drawn for the Non-Clinical and Clinical Tests

Based on the bench performance testing, biocompatibility assessment/testing, and other supporting documentation provided in this premarket notification, the subject FlareHawk Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices, and any differences between the subject device and the predicate devices do not impact the safety and effectiveness of FlareHawk Interbody Fusion System.

K201367 510k Summary Page 4 of 4

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.