(178 days)
Not Found
No
The summary describes a mechanical implant system and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Sacroiliac Joint Fixation System" intended for "sacroiliac joint fusion," indicating it is used to treat a medical condition.
No
Explanation: The device description indicates it is a "Fixation System" intended for "sacroiliac joint fusion," which is a treatment, not a diagnostic process.
No
The device description explicitly lists hardware components (SILO TFX Cone, SILO TFX Screw, SILO TFX Locking Screw, and manual surgical instruments) made of titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is an implantable device (cone, screws) used for surgical fixation of the sacroiliac joint. It is a physical device inserted into the body.
- Intended Use: The intended use is for "sacroiliac joint fusion," which is a surgical procedure, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device is a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is intended 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 Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.
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
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)
The subject device underwent static and dynamic axial compression and static and dynamic compressive shear testing per ASTM 2077, as well as static and dynamic vertical shear testing. The subject devices met all acceptance criteria for all tests. A side-by-side cadaver study was performed to support the performance of the range of motion of the SILO TFX System was compared to a legally marketed predicate device. The results of the cadaver study demonstrated that the SILO TFX System provides comparable stability of the joint to the predicate.
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.
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.
Not Found
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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October 3, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aurora Spine, Inc. % Samuel Pollard Director, Regulatory Affairs Mcra LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K221047
Trade/Device Name: SILO TFX MIS Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: August 31, 2022 Received: August 31, 2022
Dear Mr. Pollard:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
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
510(k) Number (if known)
Device Name SILO TFX MIS Sacroiliac Joint Fixation System
Indications for Use (Describe)
The Aurora Spine SILO TFX MIS Sacroillac Joint Fixation System is intended 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
| Device Trade Name: | SILO TFX MIS Sacroiliac Joint Fixation System |
|---|---|
| Manufacturer: | Aurora Spine, Inc. |
| 1930 Palomar Point Way, Suite #103, | |
| Carlsbad, CA 92008, USA | |
| Contact: | Laszlo Garamszegi |
| CTO/ Co-Founder | |
| 1930 Palomar Point Way, Suite #103 | |
| Carlsbad, CA 92008, USA | |
| Phone: 760.424.2004 | |
| Email: lgaramszegi@auroraspine.us | |
| Prepared by: | Samuel Pollard |
| Director, Regulator Affairs | |
| MCRA, LLC | |
| 803 7th Street NW, Floor 3 | |
| Washington, DC 20001 | |
| Email: spollard@mcra.com | |
| Date Prepared: | April 8, 2022 |
| Classifications: | 21 CFR §888.3040 |
| Classification Name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Common Name: | Sacroiliac Joint Fixation |
| Class: | II |
| Product Codes: | OUR |
Indications for Use:
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description:
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical
4
approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.
Primary Predicate Device:
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is substantially equivalent to the Rialto TM SI Fusion System, with regard to indications and design.
| Device Name(s) | Manufacturer | K-Number |
|---|---|---|
| RialtoTM SI Fusion System | Medtronic | K161210 |
Table 7-1· Primary Prodicato Devi
Secondary Predicate Devices:
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is substantially equivalent to the Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), and the SImmetry® Sacroiliac Joint Fusion System, with regard to indications and design.
| Table 7-2: Secondary Predicate Devices | ||
|---|---|---|
| Device Name(s) | Manufacturer | K-Number |
| Catamaran Sacroiliac Joint Fixation | ||
| System (CAT SIJ Fixation System) | Tenon Medical, Inc. | K180818 |
| SImmetry® Sacroiliac Joint Fusion System | Zyga Technology, Incorporated | K151818 |
Table 7-2 - Secondary Predicate Devices
Performance Testing Summary:
The subject device underwent static and dynamic axial compression and static and dynamic compressive shear testing per ASTM 2077, as well as static and dynamic vertical shear testing. The subject devices met all acceptance criteria for all tests. A side-by-side cadaver study was performed to support the performance of the range of motion of the SILO TFX System was compared to a legally marketed predicate device. The results of the cadaver study demonstrated that the SILO TFX System provides comparable stability of the joint to the predicate.
Comparison of Technological Characteristics:
The subject device was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
The SILO TFX MIS Sacroiliac Joint Fixation System are substantially equivalent to the cited predicate devices with respect to indications for use, design, function, materials, and performance.