SPINE360 ANTERIOR CERVICAL PLATE SYSTEM

K092531 · Spine360 · KWQ · Feb 4, 2010 · Orthopedic

Device Facts

• Record ID: K092531
• Device Name: SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Spine360
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spine 360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications: - Degenerative disc disease [DDD] defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Spinal Stenosis - Tumors - Trauma (i.e. fracture)

Device Story

Spine 360 Anterior Cervical Plate System is a spinal fixation orthosis used by surgeons in clinical settings to provide stabilization during cervical spine fusion. The system consists of an anterior plate, self-tapping fixed-angle bone screws, a locking shield, and locking shield screws. Components are provided preassembled. The device is implanted to provide mechanical support to the cervical spine (C2-C7) following surgical intervention for degenerative disc disease, spondylolisthesis, spinal stenosis, tumors, or trauma. By securing the vertebrae, the system facilitates fusion and provides stability, potentially reducing pain and restoring spinal alignment.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises an anterior plate, self-tapping fixed-angle bone screws, locking shield, and locking shield screws. Provided preassembled. Mechanical fixation device.

Indications for Use

Indicated for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in patients with degenerative disc disease (neck pain of discogenic origin with radiographic confirmation), spondylolisthesis, spinal stenosis, tumors, or trauma (fracture).

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

• Synthes CSLP

Submission Summary (Full Text)

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K092531

.

### Spine 360 Anterior Cervical Plate System

#### 510(k) Summary of Safety and Effectiveness

SUBMITTED BY

Spine 360 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746 Phone: [phone] Fax: [phone]

ESTABLISHMENT REGISTRATION NUMBER

CONTACT PERSON

Tim Hildebrand Project Manager Phone: [phone] Fax: [phone]

3005841736

SUBMISSION PREPARED BY

Lisa Peterson Kaedon Consulting, LLC Phone: [phone]

- August 11, 2009 DATE PREPARED
CLASSIFICATION

Spinal Fixation System COMMON NAME

Spine 360 Anterior Cervical Plate System PROPRIETARY NAME

Orthosis

SUBSTANTIAL EQUIVALENCE

The Spine 360 ACP System was determined to be substantially equivalent to the Synthes CSLP predicate device.

KWQ 888.3060- Spinal Intervertebral Body Fixation

#### DEVICE DESCRIPTION

The Spine 360 anterior cervical plates are provided preassembled and are offered with fixed angle bone screws. The system consists of four (4) primary components: 1) anterior plate, 2) self-tapping fixed angle bone screws, 3) locking shield screws and 4) locking shield.

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K092531 page 2 of 2

## INDICATIONS:

The Spine 360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:

- Degenerative disc disease [DDD] defined as neck pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies
- . Spondylolisthesis
- Spinal Stenosis .
- Tumors .
- . Trauma (i.e. fracture)

## MECHANICAL TEST DATA

Mechanical test results demonstrate that the Spine 360 ACP System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB - 4 2010

Spine 360 % Mr. Tim Hildebrand Project Manager 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746

Re: K092531

Trade/Device Name: Spine 360 Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 02, 2010 Received: February 03, 2010

Dear Mr. Hildebrand:

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

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Page 2 - Mr. Tim Hildebrand

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Qarbaro Buehn

Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): K(19253)

Device Name:

Spine360 Anterior Cervical Plate System

Indications for Use:

The Spine360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:

- Degenerative disc disease [DDD] defined as neck pain of discogenic origin t with degeneration of the disc confirmed by history and radiographic studies
- . Spondylolisthesis
- Spinal Stenosis .
- Tumors
- Trauma (i.e. fracture) ●

Prescription Use × (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 CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KO92531 510(k) Number__

5000 Plaza on the Lake, Suite 305 Austin, Texas 78746

Spine360

Phone: [phone] Fax: [phone]