Nile Alternative Fixation

K143350 · K2m, Inc. · OWI · Feb 25, 2015 · Orthopedic

Device Facts

• Record ID: K143350
• Device Name: Nile Alternative Fixation
• Applicant: K2m, Inc.
• Product Code: OWI · Orthopedic
• Decision Date: Feb 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. 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; 3. 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 Story

Nile Alternative Fixation System is a spinal implant system consisting of polyethylene terephthalate (PET) bands, titanium alloy clamps, and set screws. Designed for attachment to titanium or cobalt chrome spinal rods; used in posterior vertebral structures. Operates as a tethering/clamping mechanism to provide temporary stabilization during bone fusion or fracture repair. Used by surgeons in orthopedic spinal procedures. Stainless steel tips used for insertion are detached and not implanted. System provides mechanical fixation; functions as a bone anchor; aids in securing other spinal implants. Benefits include temporary stabilization of spinal constructs during healing.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance evaluated via static tensile strength, static and dynamic compression, dynamic and static band pull-through, and axial/rotational gripping capacity testing compared to predicate devices.

Technological Characteristics

System components: PET bands, titanium alloy (ASTM F136) clamps and set screws. Mechanical fixation via band-and-clamp mechanism for attachment to spinal rods. Non-active, implantable device.

Indications for Use

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

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

• Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009)
• SILC Fixation System (K133482)
• LigaPASS (K132395, K112736)
• Jazz System (K121541)
• Range/Mesa/Denali Spinal System (K120099)

Submission Summary (Full Text)

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

February 25, 2015

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

Re: K143350

Trade/Device Name: Nile Alternative Fixation Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: January 26, 2015 Received: January 27, 2015

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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Page 2 - Ms. Nancy Giezen

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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) K143350

Device Name Nile Alternative Fixation

#### Indications for Use (Describe)

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:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

2. 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 spondy lolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The NJLE 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)

> 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

#### Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: [phone] Date Prepared: 1/26/2015

### Classification

| Trade Name: | Nile Alternative Fixation |
|-------------------|---------------------------|
| Common Name: | Bone Fixation Cerclage |
| Regulatory Class: | Class II |

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

#### Predicate Device(s)

Primary Predicate:

- . Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009)
Additional Predicates:

- SILC Fixation System (K133482)
- LigaPASS (K132395, K112736)
- Jazz System (K121541) ●
- Range/Mesa/Denali Spinal System (K120099) ●

#### Device Description

The Nile Alternative Fixation 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 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.

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# Intended Use

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:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

2. 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;

3. 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 system implants were compared to predicate systems and the design features, materials and intended uses were found to be substantially the same as these systems.

# Non-clinical Performance Evaluation

The Nile Alternative Fixation system implants were mechanically 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.

#### Conclusion

There are no significant differences between the Nile Alternative Fixation 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.