SILC® Fixation System

K172417 · Globus Medical, Inc. · OWI · Oct 26, 2017 · Orthopedic

Device Facts

• Record ID: K172417
• Device Name: SILC® Fixation System
• Applicant: Globus Medical, Inc.
• Product Code: OWI · Orthopedic
• Decision Date: Oct 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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, 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.

Device Story

System consists of PET bands/cords and metal clamps for 4.5mm-6.5mm rods; used in orthopedic spinal surgery. Surgeon implants bands/cords to provide temporary bone stabilization/anchorage during fusion or fracture repair. Clamps secure bands to spinal rods. Used in OR by orthopedic surgeons. Provides mechanical stability to spinal constructs; facilitates correction of deformities or stabilization of trauma/degenerative sites. Benefits patient by maintaining alignment during bony fusion process.

Clinical Evidence

Bench testing only. Mechanical testing (static and dynamic tension, static cord pullthrough, and rod push-through) performed per ASTM F1798. Bacterial endotoxin testing (BET) performed per ANSI/AAMI ST-72:2011.

Technological Characteristics

Implants: PET bands/cords; clamps: titanium alloy, CoCrMo alloy, or stainless steel (ASTM F136, F138, F1295, F1472, F1537). Temporary bone fixation cerclage. Manual surgical instrumentation. Galvanic corrosion warning for mixed-metal constructs.

Indications for Use

Indicated for patients 8 years of age and older requiring spinal stabilization for trauma, reconstructive surgery (scoliosis, kyphosis, spondylolisthesis), or degenerative conditions as an adjunct to fusion. Used as bone anchor for temporary stabilization and fracture repair.

Regulatory Classification

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.

Predicate Devices

• SILC® Fixation System (K133482)
• Medtronic TRANSLACE™ Spinal Tethering System (K163181)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Lori Burns<br>Director, Regulatory Affairs |
| Secondary Contact: | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | August 9, 2017 |
| Device Name: | SILC® Fixation System |
| Classification: | Per 21 CFR as follows:<br>§888.3010 Bone Fixation Cerclage<br>Product Code OWI Regulatory<br>Class II, Panel Code 87 |
| Predicate(s): | Primary: SILC® Fixation System (K133482)<br>Additional: Medtronic TRANSLACE™ Spinal<br>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.