(98 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a surgical implant for bone fixation, specifically in the sacroiliac joint, to treat degenerative conditions, rather than providing therapy itself.
No
The device is described as a "Sacroiliac Joint Fusion System" intended for fixation of large bones, and performs biomechanical testing, indicating it is a surgical implant rather than a diagnostic tool.
No
The device description explicitly states that the system consists of bone screws made from Titanium alloy, which are physical hardware components. The performance studies also focus on the biomechanical properties of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliac joint disruptions." This describes a surgical implant used to physically stabilize a joint.
- Device Description: The description details bone screws made of titanium alloy, designed for surgical implantation.
- Performance Studies: The performance studies focus on the biomechanical properties of the screws (torsional properties, driving torque, pullout strength, bending strength), which are relevant to their function as a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliac joint disruptions.
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroillitis and sacroiliac joint disruptions.
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. All implants will be provided non-sterile, and are intended for single use only and should not be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the pelvis, 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 implant components were tested using the following standards:
ASTM F543 - Standard Specification and Test Methods for Metallic Bone Screws
- Annex 1 (A1) Test Method for Determining the Torsional Properties of Metallic Bone Screws .
- Annex 2 (A2) Test Method for the Driving Torque of Medical Bone Screws .
- Annex 3 (A3) Test Method for Determining the Axial Pullout Strength of Medical Bone Screws ●
ASTM F2193 – Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal . Screws
In conclusion, biomechanical testing results indicate that the Silex Sacroiliac Joint Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
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.
0
K123702
510(k) Summary
MAR 1 1 2013
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:
10/30/2012
DEVICE NAME
| Trade/Proprietary Name: | Silex™ Sacroiliac Joint Fusion System |
|---|---|
| Common Name: | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Device Class: | Class II |
| Regulation Number: | §888.3040 |
| Product Code: | OUR |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
ESTABLISHMENT REGISTRATION NUMBER
The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
INTENDED USE
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliac joint disruptions.
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. All implants will be provided non-sterile, and are intended for single use only and should not be reused under any circumstances.
1
K123702
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 System is substantially equivalent to predicate devices based on a comparison including the following characteristics:
- FDA Product Code .
- Intended Uses ●
- . Surgical Approach
- . Anatomical Region
- . Implant Materials
- . Product Dimensions
- . Mechanical Performance
PREDICATE DEVICES
- . Synthes (USA) - 6.5mm Cannulated Screw (K021932 )
- Zyga Technology, Inc. SImmetry Sacroilliac Joint Fusion System (K102907) ●
- SI-Bone, Inc. Sł Joint Fusion System (K092375) .
PERFORMANČE DATA
The implant components were tested using the following standards:
ASTM F543 - Standard Specification and Test Methods for Metallic Bone Screws
- Annex 1 (A1) Test Method for Determining the Torsional Properties of Metallic Bone Screws .
- Annex 2 (A2) Test Method for the Driving Torque of Medical Bone Screws .
- Annex 3 (A3) Test Method for Determining the Axial Pullout Strength of Medical Bone Screws ●
ASTM F2193 – Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal . Screws
In conclusion, biomechanical testing results indicate that the Silex Sacroiliac Joint Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Re:
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 11, 2013
X-Spine Systems, Inc. David Kirschman, M.D. 452 Alexandersville Rd. Miamisburg, OH 45342
K123702 Trade/Device Name: Silex 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: Jan. 30, 2013 Received: Feb. 8, 2013
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 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.
3
Page 2 - Dr. David Kirschman
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.
Erin Neith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K123702
Device Name: Silex 161 Sacroiliac Joint Fusion System
Indications for Use:
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroillitis and sacroiliac joint disruptions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethji 👍張rank -S
Division of Orthopedic Devices