The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:

Standard Thread Screw (with and without slots)
Lag Screw (with and without slots) and
Washer Screw (with slots)

AI/ML Overview

The provided text is a 510(k) premarket notification for the UNITY Sacroiliac Joint Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI might.

Therefore, many of the requested fields regarding acceptance criteria and study details for an AI-based device are not directly applicable or available in this document. The document describes mechanical performance testing and biocompatibility.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Implicit via predicate comparison and standards)	Reported Device Performance
Material Biocompatibility	Equivalent to predicate (Rexious Spinal Fixation System K111362)	Utilizes same manufacturing processes, materials, and sterilization as K111362.
Mechanical Performance	Function as intended and provide expected stability (per ASTM F2193-14 & ASTM F543-17)	"In all instances, the UNITY Sacroiliac Joint Fixation System functioned as intended and stability observed was as expected."
Intended Use	Same intended use as predicate devices.	"The UNITY Sacroiliac Joint Fixation System has the same intended uses..."
Technological Characteristics	Similar technological characteristics and principles of operation as predicate devices.	"The subject and predicate devices are based on the following same technological elements..." "The minor technological differences between the UNITY Sacroiliac Joint Fixation System and its predicate devices raise no new issues of safety or effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the mechanical tests. It states that "Three motion and stress tests were performed" and lists four tests, implying a set of samples for each test type. The data provenance is implied to be from the manufacturer (Huvexel Co., Ltd. in South Korea) through their testing activities. The nature of these tests (mechanical stress and motion) is inherently prospective as new devices would be manufactured and tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This field is not applicable. The device is a physical implant, not a diagnostic AI system requiring expert interpretation for ground truth. The "ground truth" for the mechanical performance is defined by the standards and the physical properties observed during testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This field is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical device testing. The assessment of mechanical performance is based on adherence to engineering standards and observed physical behavior.

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

This field is not applicable. The UNITY Sacroiliac Joint Fixation System is a physical implant, not an AI-assisted diagnostic tool.

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

This field is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility, the ground truth is established by referencing the prior FDA clearance of the Rexious Spinal Fixation System (K111362) which used similar materials, manufacturing processes, and sterilization. This is a form of historical data/pre-established safe use.

For mechanical testing, the ground truth is established by engineering standards (ASTM F2193-14 and ASTM F543-17) which define acceptable ranges and behaviors for the specified tests. The "functioned as intended" and "stability observed as expected" implies meeting these standards.

8. The sample size for the training set

This field is not applicable. The device is a physical implant, not an AI model requiring a training set.

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

This field is not applicable. The device is a physical implant, not an AI model.

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 and Human Services logo. To the right of that is the FDA logo, which 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.

April 26, 2018

Huvexel Co., Ltd. % Michael A. Patz, MBA, RAC Senior Regulatory/Quality Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K173201

Trade/Device Name: UNITY Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: March 28, 2018 Received: April 2, 2018

Dear Mr. Patz:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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K173201

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173201

Device Name

UNITY Sacroiliac Joint Fixation System

Indications for Use (Describe)

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)

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K173201 Page1of3

Huvexel's UNITY Sacroiliac Joint Fixation System

I. SUBMITTER

Huvexel Co. Ltd. Rm. 101~105, Megacenter, Sktechnopark 124, Sagimakgol-lo, Jungwon-gu, Soengnam, Gyeonggi, South Korea TEL: + 82.31.776.3690 Fax: +82.31.776.3691

Contact Person: Sung Hee-Lee, Quality Management Representative and Deputy Manager of Huvexel Co., Ltd.

Date Prepared: September 28, 2017

II DEVICE

Name of Device: UNITY Sacroiliac Joint Fixation System

Common or Usual Name: Sacroiliac Joint Fixation Screw

Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)

Regulatory Class: II

Product Code: OUR

III PREDICATE DEVICE

Primary Predicate: Globus Medical - SI-LOK Sacroiliac Joint Fixation System (K112028)

Additional Predicates: Depuy-Synthes - Synthes Cannulated Screw System (K021932 & K962011)

IV DEVICE DESCRIPTION

1. Standard Thread Screw (with and without slots)
1. Lag Screw (with and without slots) and

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1. Washer Screw (with slots)

V INDICATIONS FOR USE

The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following same technological elements:

Consist of a screw and a washer ●
Minimally invasive placement procedure .
Device inserted percutaneously ●
Use of a permanent implant for bone fixation ●
Mechanically securing the fixation by a permanent implant screw .

There are no know technological differences between the subject and predicate devices other than the range of screw sizes offered.

VII PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

UNITY Sacroiliac Joint Fixation System contains the following contact metallic fastener screw and washer components: titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and Cobalt-Chromium-Molybdenum (CoCr) per ASTM F1537. The biocompatibility of the UNITY Sacroiliac Joint Fixation System is based on FDA's clearance of the Rexious Spinal Fixation System (K111362) that contains tissue contact materials for similar uses. The Biocompatibility Assessment for the Unity Sacroiliac Joint Fixation System demonstrates that the Unity Sacroiliac Joint Fixation System utilizes the same manufacturing processes, materials, sterilization and similar geometry for Huvexel's

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(formerly Dio Medical, Inc.) Rexious spinal fixation system (K111362), which provides the rationale for the UNITY Sacroiliac Joint Fixation System's sterilization and biocompatibility.

Mechanical Testing

Three motion and stress tests were performed:

1. Dynamic Cantilever Test,
1. Static Cantilever Test.
1. Static Axial Pullout Test, and
1. Static Torsion Test.

Standards Applied

Performance Standard

ASTM F2193-14, Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System (Static and Dynamic Cantilever)

ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws (Static Axial Pullout and Static Torsion)

In all instances, the UNITY Sacroiliac Joint Fixation System functioned as intended and stability observed was as expected.

VIII CONCLUSIONS

The UNITY Sacroiliac Joint Fixation System is substantially equivalent to the Globus Medical- SI-LOK Sacroiliac Joint Fixation System (K112028), and the Depuy-Synthes -Synthes Cannulated Screw System (K021932 & K962011). The UNITY Sacroiliac Joint Fixation System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the UNITY Sacroiliac Joint Fixation System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the UNITY Sacroiliac Joint Fixation System is as substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.