The NILE Alternative Fixation Spinal System is a temporary implant 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 NILE Alternative Fixation Spinal 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 NILE Alternative Fixation Spinal System implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods. The band is manufactured from polyethylene terephthalate (PET) and the clamps and set screws are made from titanium alloy in accordance with ASTM F136. Once the bands are secured the stainless steel tips are detached and are not intended to be implanted.

Function: The NILE Alternative Fixation Spinal System is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.

The purpose of this submission is to allow for sterile packaging of the NILE clamps.

AI/ML Overview

This document is a 510(k) summary for the NILE Alternative Fixation Spinal System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain details about specific acceptance criteria, study designs, or performance metrics in the format requested.

The document states: "The NILE Alternative Fixation Spinal System implants were previously tested and compared to predicate devices. The NILE Alternative Fixation system implants performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity. No modifications were made to the implants and therefore additional testing was not deemed necessary."

This implies that prior studies were conducted to establish performance, but the details of those studies (acceptance criteria, specific results, sample sizes, ground truth, etc.) are not present in this 510(k) summary.

Therefore, I cannot provide the requested table and study details. This document serves as an FDA clearance letter and summary, not a detailed study report.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18. 2016

K2M, Incorporated Ms. Nancy Giezen Manager Regulatory Affairs 751 Miller Drive SE Leesburg, Virginia 20175

Re: K160208

Trade/Device Name: Nile Alternative Fixation Spinal System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: February 26, 2016 Received: February 29, 2016

Dear Ms. Giezen:

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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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 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/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 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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K160208

Device Name

NILE Alternative Fixation Spinal System

Indications for Use (Describe)

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 NILE Alternative Fixation Spinal 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.

Type of Use (Select one or both, as applicable)
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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 NILE Alternative Fixation Spinal System

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 571-919-2000 Date Prepared: 2/26/2016

Classification

NILE Alternative Fixation Spinal System Trade Name: Common Name: Bone Fixation Cerclage Class II Regulatory Class:

Classification Name(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI)

Predicate Device(s)

Primary Predicate: K2M NILE Alternative Fixation Spinal System (K143350) Secondary Predicates: K2M Range/ Denali/ Mesa Spinal System (K141873) K2M Cascadia Interbody System (K150481)

Device Description

The purpose of this submission is to allow for sterile packaging of the NILE clamps.

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Indications For Use

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 NILE Alternative Fixation Spinal 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.

Technological Comparison to Predicate(s)

The NILE Alternative Fixation Spinal System implants were compared to predicate devices and the design features, materials and intended uses were found to be substantially equivalent to these systems.

Non-clinical Performance Evaluation

The NILE Alternative Fixation Spinal System implants were previously tested and compared to predicate devices. The NILE Alternative Fixation system implants performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity. No modifications were made to the implants and therefore additional testing was not deemed necessary.

Conclusion

There are no significant differences between the NILE Alternative Fixation Spinal System implants and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and performance.

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.