(77 days)
Not Found
No
The device description and intended use focus on mechanical components for spinal fixation and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures, which is a therapeutic function. Additionally, its use in spinal fusion, correction of spinal deformities, and as an adjunct to spinal fusions clearly indicates a role in treating medical conditions.
No
The device is a fixation system used in orthopedic surgery to provide temporary stabilization and aid in bone fracture repair. Its function is interventional, not diagnostic.
No
The device description explicitly states it consists of physical components like bands, cords, clamps, and surgical instruments made of materials like PET, titanium, and stainless steel. This indicates it is a hardware-based medical device, not software-only.
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 system is for "temporary implants for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like bands, cords, clamps, and surgical instruments made of materials like PET, titanium, and stainless steel. These are all components of a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The SILC® Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The SILC® Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The SILC® Fixation System consists of bands and cords, clamps to mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. The bands and cords are manufactured from polyethylene terephthalate (PET). The bands have commercially pure titanium tips, as specified in ASTM F67, which are detached after insertion and are not intended to be implanted. The clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
8 years of age and older (for idiopathic and neuromuscular scoliosis)
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
Mechanical testing (static and dynamic tension, static cord pullthrough, and rod push-through) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Key Metrics
Not Found
Predicate Device(s)
Primary: SILC® Fixation System (K133482), Additional: Medtronic TRANSLACE™ Spinal Tethering System (K163181)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 26, 2017
Globus Medical Inc. Ms. Lori Burns Director, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K172417
Trade/Device Name: SILC® Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: August 9, 2017 Received: August 10, 2017
Dear Ms. Burns:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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/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 (DICE) 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,
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
510(k) Number (if known)
K172417
Device Name SILC® Fixation System
Indications for Use (Describe)
The SILC® Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;
· Spinal degenerative surgery, as an adjunct to spinal fusions.
The SILC® Fixation System may also be used in conjunction with other medical implants metals whenever "wiring" may help secure the attachment of other implants.
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: SILC® Fixation System Additional Implants
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Lori Burns
Director, Regulatory Affairs |
| Secondary Contact: | Kelly J. Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | August 9, 2017 |
| Device Name: | SILC® Fixation System |
| Classification: | Per 21 CFR as follows:
§888.3010 Bone Fixation Cerclage
Product Code OWI Regulatory
Class II, Panel Code 87 |
| Predicate(s): | Primary: SILC® Fixation System (K133482)
Additional: Medtronic TRANSLACE™ Spinal
Tethering System (K163181) |
Purpose:
The purpose of this submission is to request clearance for additional implants of the SILC® Fixation System.
Device Description:
The SILC® Fixation System consists of bands and cords, clamps to mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. The bands and cords are manufactured from polyethylene terephthalate (PET). The bands have commercially pure titanium tips, as specified in ASTM F67, which are detached after insertion and are not intended to be implanted. The clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.
Indications for Use:
The SILC® Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
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- . Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques:
- . Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. .
The SILC® Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Performance Data:
Mechanical testing (static and dynamic tension, static cord pullthrough, and rod push-through) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Technological Characteristics:
SILC® Fixation System additional implants devices have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
SILC® Fixation System additional implants have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate devices.