The SImmetry+ System consists of sterile packaged fully threaded titanium Implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 9.5mm-14.5mm, in 1mm increments. Implant lengths in 5mm increments range from 30mm to 110mm. All devices are additively manufactured from Titanium Alloy (Ti-6Al4V ELI).

AI/ML Overview

This 510(k) clearance letter pertains to the SImmetry+ System, a device for sacroiliac joint fusion (a metallic bone fixation fastener). Unlike a clearance for a software device or AI/ML system, this document focuses on the physical and mechanical performance of the implantable device.

Therefore, the requested information regarding acceptance criteria and study that proves the device meets the acceptance criteria specifically in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, expert consensus on images, etc.) is not applicable to this type of medical device clearance.

The provided document describes:

Device Type: A physical, implantable device (fully threaded titanium implants for sacroiliac joint fusion).
Acceptance Criteria (Implicitly): Demonstrated through non-clinical performance testing against specific ASTM standards. These standards define the expected mechanical properties (e.g., static and dynamic cantilever testing, axial pullout, torsional properties, driving torque).
Study Proving Acceptance: "Non-clinical testing data" was submitted, including:
- Static and dynamic cantilever testing per ASTM F2193
- Axial pullout testing per ASTM F543
- Torsional properties testing per ASTM F543
- Driving torque testing per ASTM F543
- Additive manufacturing characterization

Summary of Requested Information based on the provided document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Mechanical performance standards defined by ASTM F2193 and ASTM F543, and additive manufacturing characterization. (Specific numerical thresholds are not provided in this public clearance letter, but would have been part of the confidential submission.)
- Reported Device Performance: The document states that SiVantage completed non-clinical testing and the data demonstrates substantial equivalence. This implies the device met the performance criteria outlined in the standards.
Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical implants subjected to mechanical testing, not a dataset of patient information for AI/ML evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is established by engineering measurements against defined material and mechanical standards.
Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human interpretation of medical images, often with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML algorithm performance.
The type of ground truth used:
- For the physical device: Engineering specifications, material properties, and mechanical performance standards (ASTM F2193, ASTM F543).
The sample size for the training set: Not applicable. The "training set" concept applies to AI/ML model development. For a physical device, manufacturing processes are refined, but there isn't a "training set" in the AI sense.
How the ground truth for the training set was established: Not applicable for a physical device.

In conclusion, this FDA 510(k) clearance is for a conventional mechanical implant, not an AI/ML powered device. Therefore, many of the questions asked, which are highly relevant for AI/ML device clearances, do not apply to the details provided in this document. The "proof" of meeting acceptance criteria for this device rests on its physical and mechanical characteristics meeting established engineering standards and showing substantial equivalence to existing predicate devices based on those characteristics.

Summary

FDA 510(k) Clearance Letter - SImmetry+ System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 29, 2025

SiVantage
℅ Michael Coladonato
Associate Director, Regulatory Affairs
MCRA, LLC
803 7th Street NW
Washington, District of Columbia 20001

Re: K250647
Trade/Device Name: SImmetry+ System
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: OUR
Dated: July 8, 2025
Received: July 8, 2025

Dear Michael Coladonato:

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 (the 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 available 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.

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K250647 - Michael Coladonato
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250647 - Michael Coladonato
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assistance/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,

MAZIAR SHAH-MOHAMMADI -S

For: 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

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K250647

Please provide the device trade name(s).
SImmetry+ System

Please provide your Indications for Use below.
The SImmetry+ System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Please select the types of uses (select one or both, as applicable).	☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K250647
Page 1 of 2

Device Trade Name: SImmetry+ System

Manufacturer: SiVantage
14502 N. Dale Mabry Hwy
Suite 200
Tampa, FL 33618

Contact: Mr. Michael Coladonato
Associate Director, Regulatory Affairs
MCRA, LLC
803 7th Street NW
Washington, DC 20001
Phone: (202) 552-5800
Email: mcoladonato@mcra.com

Prepared by: MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Office: 202.552.5800

Date Prepared: July 24, 2025

Classifications: 21 CFR §888.3040; Smooth or threaded metallic bone fixation fastener

Class: II

Product Codes: OUR

Predicates:

SImmetry® Sacroiliac Joint Fusion System (Zyga Technology, K151818)
Synthes 6.5mm Cannulated Screw (Synthes, K021932)

Indications For Use:

The SImmetry+ System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description:

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K250647
Page 2 of 2

diameters ranging from 9.5mm-14.5mm, in 1mm increments. Implant lengths in 5mm increments range from 30mm to 110mm. All devices are additively manufactured from Titanium Alloy (Ti-6Al4V ELI).

Predicate Device:

SiVantage submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, SImmetry+ System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:

Primary Predicate: SImmetry® Sacroiliac Joint Fusion System (Zyga Technology, K151818)
Secondary Predicate: Synthes 6.5mm Cannulated Screw (Synthes, K021932)

Performance Testing Summary:

To support clearance of the subject device, SiVantage completed non-clinical testing. The non-clinical testing data submitted and relied upon to demonstrate substantial equivalence includes static and dynamic cantilever testing per ASTM F2193, axial pullout, torsional properties, and driving torque testing per ASTM F543, and additive manufacturing characterization.

Substantial Equivalence:

Equivalence for the SImmetry+ System is based on similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under K151818 and K021932.

Conclusion:

The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The SImmetry+ System is as safe, as effective, and performs as well as, or better, than 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.