(52 days)
None
No
The document makes no mention of AI, DNN, or ML, nor does it describe any image processing or other functions that would typically indicate the presence of an AI model within the device. The device description focuses on its physical components and surgical application.
Yes.
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which indicates a therapeutic purpose.
No
The device is a fusion system, not a diagnostic device. It is used to provide stabilization for sacroiliac joint fusion, not to diagnose medical conditions.
No
The device description clearly states "The RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm." This indicates the device is a physical implant made of hardware (titanium alloy screws), not solely software.
No
This device is an implantable medical device for sacroiliac joint fusion, not a diagnostic test performed on human samples.
N/A
Intended Use / Indications for Use
The Rialto™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®. Medtronic Reusable Instruments Only Compatible with the IPC® POWEREASE® System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy, MR
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject Medtronic Anterior Cervical Plate Systems were evaluated for MR-safety in accordance with the following standards:
- RF-Induced heating: ASTM F2182-19e2
- Magnetically Induced Force: ASTM F2052-21
- Magnetically Induced Torque: ASTM F2213-17
- Image Distorsion: ASTM F2119-24
- Labelling: ASTM F2503-23
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Rialto™ SI Fusion System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 26, 2025
Medtronic Sofamor Danek USA, Inc.
Rong Guo
Principle Regulatory Affairs Specialist
1800 Pyramid Place
Memphis, Tennessee 38132
Re: K251395
Trade/Device Name: Rialto™ SI 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: March 4, 2025
Received: May 5, 2025
Dear Rong Guo:
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.
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"
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K251395 - Rong Guo
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(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-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).
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K251395 - Rong Guo
Page 3
Sincerely,
Maziar Shahmohammadi -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
Page 4
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. | K251395 |
|---|---|
| Please provide the device trade name(s). |
The Rialto™ SI Fusion System
| Please provide your Indications for Use below. |
|---|
The Rialto™ SI Fusion 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) |
|---|---|
K251395 Page 1 of 1
Rialto™ SI Fusion System
Page 8 of 28
Page 5
RIALTO™ SI FUSION SYSTEM
MEDTRONIC CONFIDENTIAL K251395 Page 1 of 2
510(k) Summary
MEDTRONIC Sofamor Danek USA, Inc.
April 8, 2025
I. Submitter
Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Contact: Rong Guo
Principle Regulatory Affairs Specialist
Email: rong.guo@medtronic.com
Date Prepared: April 8, 2025
II. Subject Device
Name of Device: Rialto™ SI Fusion System
Classification Product Codes: OUR
Common name: Sacroiliac Joint Fixation
Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener
Classification: Class II
III. Predicate Devices:
Rialto™ SI Fusion System – Implant, K161210 (SE 08/12/2016)
IV. Description
RIALTO™ SI Fusion System
The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.
Medtronic Reusable Instruments Only Compatible with the IPC® POWEREASE® System
Page 6
RIALTO™ SI FUSION SYSTEM
MEDTRONIC CONFIDENTIAL K251395 Page 2 of 2
V. Indications for use
RIALTO™ SI Fusion System
The RIALTO™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
VI. Comparison of Technological Characteristics with the Predicate Devices
This 510K submission is to add MRI information to the subject devices labeling. The subject devices do not have any change of the technological characteristics from the predicate devices.
VII. Performance Data
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject Medtronic Anterior Cervical Plate Systems were evaluated for MR-safety in accordance with the following standards:
- RF-Induced heating: ASTM F2182-19e2
- Magnetically Induced Force: ASTM F2052-21
- Magnetically Induced Torque: ASTM F2213-17
- Image Distorsion: ASTM F2119-24
- Labelling: ASTM F2503-23
VIII. Conclusion:
Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the listed predicate devices.
RIALTO™ SI FUSION SYSTEM
MEDTRONIC CONFIDENTIAL
K251395 Page 2 of 2