(71 days)
Not Found
No
The document describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
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 to alleviate symptoms or restore function.
No
The device, the Silex Sacroiliac Joint Fusion System, is described as a system for sacroiliac joint fusion, consisting of bone screws for a surgical procedure. It does not mention any function for diagnosing conditions.
No
The device description explicitly states it consists of bone screws made from Titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis." This describes a surgical procedure to treat a physical condition, not a test performed on samples from the body to diagnose or monitor a disease.
- Device Description: The device is described as "bone screws" made of titanium alloy, intended for implantation. This is a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Silex Sacroiliac Joint Fusion System is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The Silex Sacroiliac Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Silex Sacroiliac Joint Fusion System consists of bone screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The Silex system is manufactured from Titanium alloy in accordance with ASTM F136, and the larger diameter (12.5mm) implants may optionally have the exterior surfaces plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. Silex implants are intended for single use only and should not be reused under any circumstances.
The implants and associated components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
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
healthcare professional
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)
No performance testing was required to support the modifications for Use as there are no changes to the technological characteristics of the device.
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.
K123702, K131405, K130092, K112028, K110472
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.
0
510(k) Summary
mar 2 5 2014
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | X-spine Systems, Inc. |
|---|---|
| 452 Alexandersville Rd. | |
| Miamisburg, OH 45342 | |
| Telephone (937) 847-8400 | |
| FAX (937) 847-8410 | |
| Official Contact: | David Kirschman, M.D. |
| Chief Medical Officer | |
| Date Prepared: | March 18, 2014 |
| DEVICE NAME | |
| Trade/Proprietary Name: | Silex™ Sacroiliac Joint Fusion System |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Description: | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Device Class: | Class II |
| Product Code: | OUR |
| Regulation Number: | §888.3040 |
ESTABLISHMENT REGISTRATION NUMBER
The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
INDICATIONS FOR USE
The Silex Sacroiliac Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
DEVICE DESCRIPTION
The Silex Sacroiliac Joint Fusion System consists of bone screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The Silex system is manufactured from Titanium alloy in accordance with ASTM F136, and the larger diameter (12.5mm) implants may optionally have the exterior surfaces plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. Silex implants are intended for single use only and should not be reused under any circumstances.
1
The implants and associated components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
The purpose of this submission is to modify the Indications for Use (IFU).
PREDICATE DEVICES
- . X-spine Systems, Inc. ~ Silex Sacroiliac Joint Fusion System (K123702)
- . SI-Bone, Inc. - iFuse Implant System (K131405)
- Zyga Technology, Inc. SImmetry Sacroillac Joint Fusion System (K130092) .
- Globus Medical, Inc. SI-LOK Sacroiliac Joint Fixation System (K112028) .
- Medtronic Sofamor Danek, Inc. MSB Sacroiliac Joint Fusion System (K110472) .
EQUIVALENCE TO MARKETED PRODUCT
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes. of FDA's regulation of medical devices, the Silex Sacroiliac Joint Fusion is substantially equivalent to predicate devices based on a comparison including the following characteristics:
- · FDA Product Code
- · Indications for Use
- · Surgical Approach
- · Anatomical Region
- . Implant Materials
- . Product Dimensions
PERFORMANCE DATA
No performance testing was required to support the modifications for Use as there are no changes to the technological characteristics of the device.
In summary, the Silex Sacroiliac Joint Fusion System is substantially equivalent to predicate devices and is capable of performing in accordance with its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2014
X-Spine Systems. Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K140079
Trade/Device Name: SilexTM 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: February 10, 2014 Received: February 11, 2014
Dear Dr. Kirschman:
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
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
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Page 2 - David Kirschman. M.D.
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.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 Small Manufacturers. International and Consumer Assistance 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 yours.
Ronald P. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Silex Sacroiliac Joint Fusion System
Indications for Use (Describe)
The Silex Sacroiliar Joint Fusion System is intended for sacroilias joint fusion for conditions including secroiliae joint discuptions 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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Davices and Radiological Health (CDRH) (Signature)
Dmitrie . PhD Division o a ere Devices
FORM FDA 3881 (9/13)
PSC Publishang Sernata (101) 44) 6740 ସମ