(90 days)
The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Reunion Sacroiliac (SI) Joint Fusion System is a screw system designed to provide fixation across the sacroiliac joint to promote fusion. The screws are accompanied by a modular screw head that provides additional fixation points to the bone. A secondary screw option is a compression screw that does not affix to the modular heads. The system is supported by a comprehensive set of instruments to install the screw implants within the system.
The provided text is a 510(k) summary for the REUNION Sacroiliac Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/algorithm-based diagnostic or screening tool.
Therefore, the requested information regarding acceptance criteria, linked study designs, ground truth establishment, expert adjudication, or MRMC studies for an AI device is not applicable to this document.
Here's why and what information is available in the provided text:
- Device Type: The REUNION Sacroiliac Joint Fusion System is a physical medical device (a screw system for bone fixation), not an AI/algorithm.
- Approval Pathway: It's being approved via a 510(k) pathway, which primarily requires demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical and material testing, rather than clinical performance trials to prove a specific numerical measure of diagnostic accuracy.
- "Clinical Test Summary": The document explicitly states "No clinical studies were performed" (page 5), reinforcing that the evaluation was not based on human clinical performance data against a specific acceptance criterion.
Based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving the device meets those criteria, as these concepts, in the context described (e.g., AI/algorithm performance), are not present or relevant to this 510(k) submission.
The acceptance criteria for this type of device (a physical implant) would typically be met through:
- Material compatibility and strength: Demonstrated by tests like those listed (Torsional Properties, Driving Torque, Axial Pullout Strength, Static/Dynamic Cantilever Bending) according to relevant ASTM standards. The "acceptance criteria" here would be meeting the specified mechanical property ranges or failure modes outlined in those standards, and showing equivalence to the predicate devices.
- Design and manufacturing controls: Adherence to Quality System (QS) regulation (21 CFR Part 820).
- Labeling requirements.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests summarized on page 5:
- Torsional Properties (ASTM F543)
- Driving Torque (ASTM F543)
- Axial Pullout Strength (ASTM F543)
- Static Cantilever Bending (ASTM F2193)
- Dynamic Cantilever Bending (ASTM F2193)
These tests are designed to show that the device performs mechanically as intended and is substantially equivalent to predicate devices. However, the document does not enumerate specific numerical acceptance criteria for these tests or explicitly state the reported device performance against those numerical criteria in a table within the provided text. It merely states that "The REUNION Sacroiliac Joint Fusion System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances."
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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 24, 2023
Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063
Re: K232211
Trade/Device Name: REUNION Sacroiliac 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: July 25, 2023 Received: July 26, 2023
Dear Parker Kelch:
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 (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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(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 OS 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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Colin O'neill -S" in black font on the left side of the image. On the right side of the image is the letters "FDA" in a light blue color. The letters "FDA" are larger than the name on the left side of the image.
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) K232211
Device Name REUNION Sacroiliac Joint Fusion System
Indications for Use (Describe)
The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| 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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510(k) Summary: REUNION Sacroiliac Joint Fusion System
| Date Prepared | July 25, 2023 |
|---|---|
| Submitted By | Astura Medical4949 W Royal LnIrving, TX 75063 |
| Contact | Parker Kelch4949 W Royal LnIrving, TX 75063Phone: 469-501-5530 x503Email: parker@asturamedical.com |
| Trade Name | REUNION Sacroiliac Joint Fusion System |
| Common Name | Sacroiliac Joint Fixation |
| Classification Name | Smooth of threaded metallic bone fixation fastener |
| Class | II |
| Product Code | OUR |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate Device | RIALTO SI Fusion System (K161210) |
| Additional PredicateDevice | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671) |
| Reference PredicateDevice | Olympic Posterior Spinal Fixation System (K182239) |
| Device Description | The Reunion Sacroiliac (SI) Joint Fusion System is a screw system designedto provide fixation across the sacroiliac joint to promote fusion. Thescrews are accompanied by a modular screw head that providesadditional fixation points to the bone. A secondary screw option is acompression screw that does not affix to the modular heads. The systemis supported by a comprehensive set of instruments to install the screwimplants within the system. |
| Materials | Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136Nitinol #1 (ASTM F2063) |
| Substantial EquivalenceClaimed to PredicateDevices | The Reunion Sacroiliac (SI) Joint Fusion System is substantially equivalentto the predicate devices in terms of intended use, design, materials used,mechanical safety and performances. |
| Indications for Use | The REUNION SI Joint System is indicated for skeletally mature patientsfor sacroiliac joint fusion for conditions including sacroiliac jointdisruptions and degenerative sacroiliitis. |
| Non-clinical Test Summary | The following analyses were conducted: |
| Torsional Properties ASTM F543 Driving Torque ASTM F543 Axial Pullout Strength ASTM F543 Static Cantilever Bending ASTM F2193 Dynamic Cantilever Bending ASTM F2193 | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical and Clinical | Astura Medical considers the REUNION Sacroiliac Joint Fusion System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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§ 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.