(90 days)
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI or ML technologies.
Yes
The device is indicated for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," which is a treatment for medical conditions.
No
Explanation: The device is a screw system designed to provide fixation to promote fusion, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "screw system" and includes "implants" and "instruments," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." This describes a surgical procedure to treat a physical condition.
- Device Description: The device is described as a "screw system designed to provide fixation across the sacroiliac joint to promote fusion." This is a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
The information provided describes a surgical implant and its associated instruments, which are medical devices but not IVDs.
N/A
Intended Use / Indications for Use
The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
skeletally mature patients
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RIALTO SI Fusion System (K161210), M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Olympic Posterior Spinal Fixation System (K182239)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 Medical |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Contact | Parker Kelch |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 x503 | |
| Email: 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 Predicate | |
| Device | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671) |
| Reference Predicate | |
| Device | Olympic Posterior Spinal Fixation System (K182239) |
| Device Description | 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. | |
| Materials | Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136 |
| Nitinol #1 (ASTM F2063) | |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The Reunion Sacroiliac (SI) Joint Fusion System is substantially equivalent |
| to 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 patients |
| for sacroiliac joint fusion for conditions including sacroiliac joint | |
| disruptions 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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