KESTREL POSTERIOR CERVICAL SPINE SYSTEM

K132122 · Omni Surgical, LLC Dba Spine360 · KWP · Jan 22, 2014 · Orthopedic

Device Facts

• Record ID: K132122
• Device Name: KESTREL POSTERIOR CERVICAL SPINE SYSTEM
• Applicant: Omni Surgical, LLC Dba Spine360
• Product Code: KWP · Orthopedic
• Decision Date: Jan 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications: - Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Trauma (i.e fracture or dislocation) - Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop

Device Story

Kestrel Posterior Cervical Fixation System; spinal implant construct consisting of screws, locking caps, rods, cross links, hooks, and wires. Used by surgeons in clinical settings to stabilize vertebrae during fusion of cervical spine and occipito-cervico-thoracic junction (Occiput-T3). Implants provide mechanical stabilization to promote bone fusion; surgeon selects components based on patient anatomy and pathology. Benefits include structural support for spinal segments affected by degenerative disease, trauma, or deformity. System components are manually assembled and secured by the surgeon.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F2706-08, including static compression bending, static torsion, dynamic compression bending, and dynamic torsion. Results indicated performance comparable or superior to the predicate device.

Technological Characteristics

Implants: Titanium alloy Ti-6Al-4V (ISO 5832/3), conforming to ASTM F136-02a. Instruments: Surgical grade stainless steel (ISO 7153/I). System includes screws, locking caps, rods, cross links, hooks, and wires. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring posterior cervical or occipito-cervico-thoracic (Occiput-T3) fusion due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion. Contraindications: Pedicle screws not for cervical spine; pedicle screws limited to T1-T3 for OCT constructs; occipital screws limited to occipital fixation.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Anatomica Posterior Cervical Fixation System (K061943)

Submission Summary (Full Text)

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SPINE
360

5000 Plaza on the Lake, Suite 305 Austin, TX 78746 512-327-6400 800-640-6045 Fax · Dave Lamb [e-mail]

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: .

January 17, 2014

CLASS OF DEVICE

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RE: 510(k)
Premarket Notification - Kestrel Posterior Cervical Fixation System K132122

Traditional 510(k) Summary

| ESTABLISHMENT REGISTRATION NUMBER | 3005841736 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Primary<br>Dave Lamb<br>Quality and Regulatory Affairs<br>Phone: [phone] ext. 24<br>Fax: [phone] |
| DATE PREPARED | June 30, 2013 |
| CLASSIFICATION NAME | KWP 888.3050 - Spinal Interlaminal Fixation Orthosis |
| COMMON NAME | Posterior Occipital Cervico-thoracic Spinal System |
| TRADE NAME | Kestrel Posterior Cervical Fixation System |
| PREDICATE DEVICE | Anatomica Posterior Cervical Fixation System K061943 |

Class II

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## DEVICE DESCRIPTION

The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.

#### INTENDED USE

The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:

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

Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop

### TECHNOLOGICAL CHARACTERISTICS

The Kestrel Posterior Cervical System implants are manufactured from titanium alloy, Ti - A16 -4V (ISO 5832/3), which conforms to ASTM F136-02a (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications) material standards. The associated Class I instruments are made primarily of surgical grade stainless steel (ISO 7153/I).

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#### SUBSTANTIAL EQUIVALENCE

| | Anatomica | Kestrel |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | • Degenerative disc<br>disease (DDD)<br>• Spondylolisthesis<br>• Trauma<br>• Spinal stenosis,<br>curvatures<br>• Tumor<br>• Pseudoarthrosis<br>• Failed previous fusion | • Degenerative disc<br>disease (DDD)<br>• Spondylolisthesis<br>• Trauma<br>• Spinal stenosis,<br>curvatures<br>• Tumor<br>• Pseudoarthrosis<br>• Failed previous fusion |
| Material | Titanium 6Al 4V ELI | Titanium 6Al 4V ELI |
| Design features | Screws, connectors, hooks,<br>wires, rods connected to<br>stabilize the vertebrae during<br>fusion | Screws, connectors, hooks,<br>wires, rods connected to<br>stabilize the vertebrae during<br>fusion |

# PERFORMANCE TESTING TO ESTABLISH SUBSTANTIAL EQUIVALENCE

Mechanical Testing was performed in accordance with ASTM F2706-08 "Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model" including Static Compression Bending, Static Torsion, Dynamic Compression Bending, Dynamic TorsionThe results of the testing indicate that the Kestrel performed comparably or superior to the Anatomica predicate system.

# CONCLUSIONS

The Kestrel Posterior Cervical System demonstrated substantial equivalence to the predicate Anatomica System (K061943).

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Public Health Service

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

January 22, 2014

Omni Surgical, LLC (dba. Spine 360) Mr. David Lamb 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746

Re: K132122

Trade/Device Name: Kestrel Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminar fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 11, 2013 Received: December 12, 2013

Dear Mr. Lamb:

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 - Mr. David Lamb

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Lori A. Wiggins

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

Enclosure

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K132122 - Page 1 of 1

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5000 Plaza on the Lake, Suite 305 Austin, TX 78746 512-327-6400

RE: 510(k) K132122 Premarket Notification - Kestrel Posterior Cervical Fixation System Indications for Use

The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:

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

Occipital bone screws are limited to occipital fixation only. Pedicle screws are limited to placement in the upper thoracic spine (T1-T3), when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Zane W. Wyatt-S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132122