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.

Device Description

The SILC™ Fixation System consists of bands, clamps that mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. Bands are manufactured from polyethylene terephthalate (PET) with commercially pure titanium tips per ASTM F67, and 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.

AI/ML Overview

Acceptance Criteria and Device Performance for SILC™ Fixation System

Given the provided text, the SILC™ Fixation System's acceptance criteria and the study proving its performance are based on mechanical testing against established industry standards and guidance documents. The submission focuses on demonstrating "substantial equivalence" to predicate devices rather than individual clinical efficacy or performance metrics against specific, pre-defined numerical thresholds for a new, unestablished technology.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Performance	Static band tension (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004")	Performance data demonstrate substantial equivalence to the predicate devices.
	Static and dynamic band pull-through (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004")	Performance data demonstrate substantial equivalence to the predicate devices.
	Static axial grip (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004")	Performance data demonstrate substantial equivalence to the predicate devices.
	Static torsion grip (in accordance with ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004")	Performance data demonstrate substantial equivalence to the predicate devices.
Material Compatibility (Implied)	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.	(Implied that the device design and labeling adhere to this criterion to prevent incompatibility)
Intended Use Equivalence	Similar with respect to technical characteristics, performance, and intended use as predicate devices.	The SILC™ Fixation System performs as well as or better than the predicate devices.

Note: The document explicitly states "Performance data demonstrate substantial equivalence to the predicate devices" and "The SILC™ Fixation System performs as well as or better than the predicate devices." This is the core performance claim for a 510(k) submission, indicating that the device meets the functional requirements by being comparable to already approved devices. Specific numerical performance metrics for each test are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The testing was mechanical in nature, likely involving a sufficient number of samples to meet the requirements of ASTM F1798 and the FDA guidance. However, the exact number tested for each specific test (e.g., how many bands for static tension) is not disclosed in this summary.
Data Provenance: Not explicitly stated regarding country of origin. The study is prospective in the sense that the testing was conducted specifically for this 510(k) submission based on the manufactured device. It is not a retrospective analysis of clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This was a mechanical performance study, not a clinical study requiring expert assessment of patient data to establish ground truth. The "ground truth" for these tests would be the established scientific principles and measured physical properties according to the specified ASTM standard.

4. Adjudication Method for the Test Set

Not applicable. As a mechanical testing study, there is no "adjudication method" in the sense of reconciling divergent expert opinions on patient cases. The results are objective measurements based on the test methodology.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a mechanical device, and its performance evaluation does not involve human readers interpreting images or clinical outcomes in comparison to AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Yes, a standalone study was done. The mechanical tests (static band tension, static and dynamic band pull-through, static axial grip, and static torsion grip) represent the standalone performance of the device's components against physical forces, without human intervention or interpretation during the testing process itself.

7. Type of Ground Truth Used

The ground truth used was based on established engineering standards and regulatory guidance for mechanical testing of spinal fixation systems (ASTM F1798 and "Guidance for Spinal System 510(k)s, May 3, 2004"). The performance was measured against the functional requirements implied by these standards and by demonstrating substantial equivalence to predicate devices which have already met these standards.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. The design and manufacturing processes are likely "trained" through iterative design, prototyping, and testing, but not in the sense of a data-driven algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an algorithm. The design and material choices would have been validated through engineering principles and adherence to recognized standards.

Summary

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510(k) Summary: SILC™ Fixation System

MAY 2 1 2014

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403
610-930-1800

Christina Kichula Contact: Group Manager, Regulatory Affairs

Date Prepared: November 12, 2013
SILC™ Fixation System Device Name:

Per 21 CFR as follows: Classification: &888.3010 Bone Fixation Cerclage, Sublaminar Product Codes OWI Regulatory Class II, Panel Code 87

Zimmer Spine Universal Clamp Spinal Fixation System, Predicate(s): K060009. K110348 Medicrea LigaPASS, K112736 Pioneer Songer Cable System, K922952

Purpose:

The purpose of this submission is to request clearance of the SILC™ Fixation System.

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

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

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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 band tension, static and dynamic band pull-through, static axial grip, and static torsion grip) was conducted in accordance with ASTM F1798 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices.

Conclusions / Basis of Substantial Equivalence:

The SILC™ Fixation System implants are similar to the predicate implants with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. The SILC™ Fixation System performs as well as or better than the predicate devices.

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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

May 21, 2014

Globus Medical. Incorporated Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K133482

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: April 21, 2014 Received: April 22, 2014

Dear Ms. Kichula:

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. Christina Kichula

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.

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/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/ReportalProblem/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 yours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K133482 510(k) Number:

SILC™ Fixation System Device Name:

INDICATIONS:

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 scollosis 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.

x Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

James P. Bertram -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133482

Regulation Number and Section

§ 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.