The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.

Device Description

The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. The subject submission introduces additional designs and sizes of the arch screw and locking screw.

Arch Screw will be implanted in patient's bone then autograft will be inserted.
Locking Screw can be used with washer or can be used on its own
Self-tapping flute centers screw for easy insertion

AI/ML Overview

The provided text is a 510(k) summary for the ZESPIN SI Joint Fusion System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance as would be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable or present in this document.

However, I can extract what is available regarding performance testing and regulatory conclusions:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance based on a study, nor does it report specific performance metrics like accuracy, sensitivity, or specificity. Instead, it relies on a "risk assessment, including FE analysis" and comparison to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Do not introduce new issues of safety/effectiveness	Risk assessment and FE analysis confirmed no new safety/effectiveness issues.
Additional components are not worst-case	Confirmed that additional components are not the worst case.
Substantially equivalent to predicate	Overall technology characteristics lead to conclusion of substantial equivalence to predicate (K210035).

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

Not applicable. This is a mechanical device submission, not an AI/ML device requiring a test set of data. The "test" here refers to engineering assessments.

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

Not applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant for this type of device submission. The "ground truth" for proving safety and effectiveness relies on engineering principles, materials science, and established regulatory pathways for similar devices.

4. Adjudication method for the test set

Not applicable.

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/ML-driven diagnostic or assistive device.

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

Not applicable.

7. The type of ground truth used

For this device, the "ground truth" for acceptability is based on:

Engineering principles and analysis (e.g., Finite Element Analysis - FEA).
Compliance with material standards (Ti-6Al-4V ELI titanium alloy per ASTM F136).
Demonstration of substantial equivalence to a legally marketed predicate device (K210035).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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January 20, 2023

Image /page/0/Picture/1 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.

Aegis Spine, Inc. Kihyang Kim RA 9781 S. Meridian Blvd. Ste 300 Englewood, Colorado 80112

Re: K223521

Trade/Device Name: ZESPIN SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: November 20, 2022 Received: November 23, 2022

Dear Kihyang Kim:

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) K223521

Device Name

ZESPIN SI Joint Fusion System

Indications for Use (Describe)

The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	Over The Counter Use (21 C.FR 801 Submart C)

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510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1. MANUFACTURER

Submitter's Name:	Aegis Spine, INC.
Submitter's Address:	9781 S. Meridian Blvd, Ste 300Englewood, CO 80112
Submitter's Telephone:	+1.303.741.4123
Contact Person:	Kihyang Kim+1.303.741.4123khkim@aegisspine.com/khkim3747@gmail.com

2. DEVICE IDENTIFICATION

Device Trade Name	ZESPIN SI Joint Fusion System
Common/Usual Name	Sacroiliac joint fixation, Bone Screw
Regulation Class /Number	Class II / 21 CFR 888.3040
Regulation Name	Smooth or threaded metallic bone fixation fastener
Product Code	OUR
Classification Panel	Spinal Devices (DHT6B)

3. PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT.

The subject devices are similar to the predicate devices in all characteristics.

Subject Device Name	510K NO.	Trade or Proprietary or Model Name	Predicate Type
ZESPIN SI Joint	K 210035	ZESPIN SI Joint Fusion System	Primary
Fusion System	K 152237	Entasis™ Dual-Lead Sacroiliac Implant	Additional

The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices.

4. MATERIALS

ZESPIN SI Joint Fusion System	Ti-6Al-4V ELI titanium alloy (ASTM F136)
And the additional components material is the same material used in the predicate devices (K210035)

And the additional components material is the same material used in the predicate devices (K 210035).

ട്. DESCRIPTION OF THE DEVICE

Arch Screw will be implanted in patient's bone then autograft will be inserted. ●
. Locking Screw can be used with washer or can be used on its own
. Self-tapping flute centers screw for easy insertion

6. INDICATION FOR USE

The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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7. PERFORMANCE TESTING

ZESPIN SI Joint Fusion System

A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The risk assessment confirmed that none of the additional components is the worst case of the ZESPIN SI Joint Fusion System and the additional components added through this submission do not require additional mechanical testing.

Therefore, we substitute mechanical test data of ZESPIN SI Joint Fusion System for additional components with the predicate device data (K210035).

8. SUMMARY OF TECHNOLOGY CHARACTERISTICS

Subject devices are similar to the predicate devices in all (Material, Indication for use, Design, Manufacturing process, Surgical approach) characteristics

SUBSTANTIAL EQUIVALENCE 9.

Subject devices are substantially equivalent to the predicate devices in indications for use, design, function and materials used.

10. CONCLUSION

The overall technology characteristics lead to the conclusion that the ZESPIN SI Joint Fusion System is substantially equivalent to the predicate devices(K210035).

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.