SKYHAWK LATERAL PLATE SYSTEM

K140260 · Orthofix, Inc. · KWQ · Jul 2, 2014 · Orthopedic

Device Facts

• Record ID: K140260
• Device Name: SKYHAWK LATERAL PLATE SYSTEM
• Applicant: Orthofix, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); Spondylolisthesis; Spinal stenosis; Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; Failed previous fusion; and Trauma (i.e., fracture or dislocation).

Device Story

Non-sterile, single-use spinal fixation system; consists of titanium alloy (Ti6Al4V ELI) rigid plates, bone screws, and set screws. Used by surgeons for anterolateral or lateral fixation of thoracic and lumbar vertebral bodies (T1-L5). Implants provide mechanical immobilization and stabilization of spinal segments to facilitate fusion. System includes specialized instrumentation for surgical implantation. Requires sterilization by user prior to procedure. Clinical benefit derived from stabilizing spinal segments in patients with acute or chronic instabilities.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with ASTM F1717-13 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) including static and dynamic axial compression bending and static torsion testing. No clinical data presented.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V ELI per ASTM F136). Components: Rigid plates, bone screws, set screws. Fixation: Non-pedicle lateral/anterolateral. Sterilization: Non-sterile, requires user sterilization. Testing: ASTM F1717-13.

Indications for Use

Indicated for skeletally mature patients requiring immobilization/stabilization of thoracic and lumbar spine (T1-L5) as an adjunct to fusion for degenerative disc disease, spondylolisthesis, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, failed previous fusion, or trauma (fracture/dislocation).

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Blackstone Medical Spinal Fixation System (SFS) (K080407)
• Blackstone Medical Spinal Fixation System (SFS) (K023498)
• NuVasive Lateral Plate System (K091071)
• NuVasive Lateral Plate System (K061789)
• Globus Medical Plymouth Thoracolumbar Plate System (K120092)

Submission Summary (Full Text)

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# OFIX:

5.0

### SKYHAWK™ Lateral Plate System

.'

### 510(k) Summary

# 2014

K140260 page 1 of 2

| Date Prepared: | May 30, 2014 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose for Submission: | New product offering |
| Sponsor: | Orthofix<br>Troy Brooks, RAC<br>3451 Plano Parkway<br>Lewisville, Texas 75056<br>214-937-2047 |
| Device Name: | SKYHAWK™ Lateral Plate System |
| Product Code: | KWQ |
| Classification: | Class II - 21 CFR § 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Predicate Device: | Blackstone Medical Spinal Fixation System (SFS) - K080407<br>Blackstone Medical Spinal Fixation System (SFS) - K023498<br>NuVasive Lateral Plate System - K091071<br>NuVasive Lateral Plate System - K061789<br>Globus Medical Plymouth Thoracolumbar Plate System - K120092 |
| Device Description: | The SKYHAWK Lateral Plate System consists of an assortment of non-<br>sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid<br>plates, bone screws, and set screws. The.plates attach by means of screws<br>to the anterolateral or lateral portion of the vertebral body of the<br>thoracolumbar spine (T1-L5). The system includes instrumentation which<br>assists in the surgical implantation of the devices. The SKYHAWK Lateral<br>Plate System implants and instruments are provided non-sterile. They<br>require sterilization prior to use. |
| Intended Use: | The SKYHAWK Lateral Plate System is intended to be used as a non-<br>pedicle lateral or anterolateral fixation system in skeletally mature patients<br>and is intended to provide immobilization and stabilization of spinal<br>segments, as an adjunct to fusion in the treatment of the following acute<br>and chronic instabilities of the thoracic and lumbar spine. It may be used<br>from levels T1 to L5 with the following indications:<br><ul><li>Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);</li><li>Spondylolisthesis;</li><li>Spinal stenosis;</li><li>Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);</li><li>Tumor;</li><li>Pseudoarthrosis;</li><li>Failed previous fusion; and</li><li>Trauma (i.e., fracture or dislocation).</li></ul> |
| Non-Clinical Testing: | Mechanical testing of the SKYHAWK Lateral Plate System consisting of<br>static and dynamic axial compression bending testing and static torsion<br>testing was conducted in accordance with ASTM F1717-13 "Standard Test<br>Methods for Spinal Implant Constructs in a Vertebrectomy Model." Test |

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K140260

page 2 of 2

results demonstrate that the SKYHAWK Lateral Plate System performs as well or better than the predicate device and is therefore substantially equivalent to the predicate device.

Conclusion: Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the SKYHAWK Lateral Plate System is substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

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

July 2, 2014

Orthofix, Incorporated Troy Brooks, RAC Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K140260

Trade/Device Name: SKYHAWK™ Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 30, 2014 Received: June 2, 2014

Dear Mr. Brooks:

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 - Troy Brooks. RAC

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.

ff 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/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/McdicalDevices/Safctv/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 yours.

### 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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#### 4.0 Indications for Use Statement

510(k) Number (if known): K 140260

Device Name: SKYHAWKTM Lateral Plate System

Indications for Use:

The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels Tl to L5 with the following indications:

- · Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis;
- · Spinal stenosis;
- · Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · Tumor;
- · Pseudoarthrosis;
- · Failed previous fusion; and
- · Trauma (i.e., fracture or dislocation).

Prescription Use x AND/OR (Per 21 CFR 801.109)

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

## Anton E. Dmitriev, PhD Division of Orthopedic Devices