(30 days)
Not Found
No
The device description focuses on the physical characteristics and materials of the implants, with no mention of AI or ML technology.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which directly addresses a medical condition.
No
This device is a surgical implant designed to provide stability for bony fusion in the sacroiliac joint, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it consists of "sterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The SImmetry Sacroiliac Joint Fusion System is described as a system of implants (screws) made of titanium. These implants are surgically placed to stabilize the sacroiliac joint.
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure to stabilize the joint.
The device is a surgical implant used in the body, not a device used to test samples from the body.
N/A
Intended Use / Indications for Use
The SImmetry® Sacroiliac Joint Fusion is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged partially threaded or fully threaded, self-tapping cannulated 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 diameters ranging from 6.5mm-14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm-14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint, sacrum, ilium
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
No performance data is required to support this Special 510(k). This Special 510(k) does not involve any changes to the technological characteristics of the device. The principle of operation of the subject device is identical to that of the predicate device cleared under K141549, SImmetry Sacroiliac Joint Fusion System.
Key Metrics
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2015
Zyga Technology, Incorporated Ms. Diane Brinza Director of Regulatory Affairs 5600 Rowland Road, Suite 200 Minnetonka, Minnesota 55343
Re: K151818
Trade/Device Name: SImmetry ® 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 3, 2015 Received: July 6, 2015
Dear Ms. Brinza:
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. 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 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 803); good manufacturing practice requirements as set
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Page 2 - Ms. Diane Brinza
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151818
Device Name SImmetry® Sacroiliac Joint Fusion System
Indications for Use (Describe)
The SImmetry® Sacroiliac Joint Fusion is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.
Type of Use (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
[As required by 21 CFR 807.92(c)]
| Date of Preparation | July 3, 2015 |
|---|---|
| Submitter' Name | |
| and Address | Zyga Technology, Inc. |
| 5600 Rowland Road, Suite 200 | |
| Minnetonka, MN 55343 | |
| Contact Person | Diane Brinza |
| Director of Regulatory Affairs | |
| Ph. 952-698-9959 | |
| Fax. 952-698-9940 | |
| dbrinza@zyga.com | |
| Proprietary Name | SImmetry® Sacroiliac Joint Fusion System |
| Common / Usual | |
| Name | Sacroiliac Joint Fixation |
| Bone Screw | |
| Classification | Class II per 21 CFR Part 888.3040 |
| Smooth or threaded metallic bone fixation fastener | |
| Division of Orthopedic Devices | |
| Product Code | OUR |
| Manufacturer | Zyga Technology, Inc. |
| 5600 Rowland Road, Suite 200 | |
| Minnetonka, MN 55343 | |
| Predicate Device | K141549 SImmetry Sacroiliac Joint Fusion System |
| Device Description | The SImmetry Sacroiliac Joint Fusion System consists of |
| sterile packaged partially threaded or fully threaded, self- | |
| tapping cannulated 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 | |
| diameters ranging from 6.5mm-14.5mm, in 2mm | |
| increments. Lengths in 5mm increments range from 30mm- | |
| 110mm for fully threaded implants and 50mm to 110mm | |
| for partially threaded implants. All partially threaded | |
| implants and 6.5mm diameter fully threaded implants have | |
| a pre-assembled washer. Individually sterile packaged | |
| washers are available for fully threaded implants having | |
| diameters ranging from 8.5mm-14.5mm. | |
| All devices are manufactured from Titanium Alloy (Ti-6Al- | |
| 4V ELI). | |
| Indication for Use | The SImmetry Sacroiliac Joint Fusion System is intended |
| for sacroiliac joint fusion for conditions including sacroiliac | |
| ioint disruptions and degenerative sacroiliitis. | |
| Performance Data | No performance data is required to support this Special |
| 510(k). | |
| Technology | This Special 510(k) does not involve any changes to the |
| technological characteristics of the device. The principle of | |
| operation of the subject device is identical to that of the | |
| predicate device cleared under K141549, SImmetry | |
| Sacroiliac Joint Fusion System. | |
| Substantial | |
| Equivalence | |
| Conclusion | 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 K141549, | |
| SImmetry Sacroiliac Joint Fusion System. |
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