SImmetry+ System

K250647 · Sivantage · OUR · Jul 29, 2025 · Orthopedic

Device Facts

• Record ID: K250647
• Device Name: SImmetry+ System
• Applicant: Sivantage
• Product Code: OUR · Orthopedic
• Decision Date: Jul 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

SImmetry+ System consists of sterile, additively manufactured titanium alloy (Ti-6Al4V ELI) implants; designed to transfix sacrum and ilium to provide stability for bony fusion. Implants available in various diameters (9.5mm-14.5mm) and lengths (30mm-110mm) to accommodate patient anatomy. Used by surgeons in clinical settings to stabilize the sacroiliac joint; facilitates fusion process. Output is physical fixation of joint; aids clinical decision-making by providing mechanical stability required for arthrodesis. Benefits patient through stabilization of joint, potentially reducing pain associated with sacroiliac joint disruptions or degenerative sacroiliitis.

Clinical Evidence

Bench testing only. Testing included static and dynamic cantilever testing per ASTM F2193, axial pullout, torsional properties, and driving torque testing per ASTM F543, and additive manufacturing characterization.

Technological Characteristics

Material: Titanium Alloy (Ti-6Al4V ELI). Manufacturing: Additive manufacturing. Design: Fully threaded metallic bone fixation fasteners. Dimensions: 9.5mm-14.5mm diameter; 30mm-110mm length. Standards: ASTM F2193 (cantilever testing), ASTM F543 (axial pullout, torsion, driving torque). Sterilization: Sterile packaged.

Indications for Use

Indicated for patients requiring sacroiliac joint fusion due to sacroiliac joint disruptions or degenerative sacroiliitis.

Regulatory Classification

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.

Predicate Devices

• SImmetry® Sacroiliac Joint Fusion System (K151818)
• Synthes 6.5mm Cannulated Screw (K021932)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

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

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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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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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: [phone]
Email: [e-mail]

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:

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

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K250647
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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.