VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM

K121078 · Accel Spine · KWQ · Sep 13, 2012 · Orthopedic

Device Facts

• Record ID: K121078
• Device Name: VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Accel Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin . withdegeneration of the disc confirmed by patient history and radiographic studies). - . spondy lolisthesis, - . trauma (i.e. fractures or dislocations), - . tumors, - . deformity (defined as kyphosis, lordosisor scoliosis), - . pseudarthrosis. - . failed previous fusion, - . spinal stenosis.

Device Story

VAN GOGH Anterior Cervical Plate System; titanium alloy (Ti-6AI-4V ELI) plates and screws; used for anterior cervical spine (C2-C7) fixation; provides immobilization and stabilization as adjunct to fusion. Surgeon implants plates and screws during surgical procedures; screws available in fixed/variable, self-tapping/self-drilling configurations (3.5mm and 4.0mm diameter). System supports one to four-level procedures. Benefits include spinal stabilization for patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

Bench testing only. Static compression bending, tension, torsion, and dynamic compression bending performed according to ASTM F1717 on worst-case cervical plate construct. Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Materials: Titanium alloy Ti-6AI-4V ELI (ASTM F136). Components: Plates and 3.5mm/4.0mm diameter bone screws (fixed/variable, self-tapping/self-drilling). Lengths: 12-20mm. Design: Anterior cervical plate system for 1-4 level procedures.

Indications for Use

Indicated for patients requiring cervical spine (C2-C7) immobilization and stabilization as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusion, and spinal stenosis.

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

• Maxima™ Anterior Cervical Plate System (K061002)
• Synthes Anterior Cervical Locking Plate(ACLP) System (K031276)
• ZEPHIR™ Anterior Cervical Plate System (K994239, K030327)
• LEXUS Anterior Cervical Plate System (K113509)
• SKYLINE Anterior Cervical Plate System (K103491)

Submission Summary (Full Text)

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K121078

SEP 13 2012

#### CAccessPINE

## 510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

| Submitter: | Accel SPINE LLC |
|-----------------|-----------------------------|
| | 14850 Quorum Dr. Suite 220 |
| | Dallas, TX 75254,USA |
| Contact Person: | Daniel Chon |
| | Phone.[phone] |
| | Fax.[phone] |
| | [e-mail] |
| Date prepared: | April 5, 2012 |

#### 2. Device Identification

| Trade Name | VAN GOGH Anterior Cervical Plate System |
|-------------------|----------------------------------------------|
| Common Name | Anterior Cervical Plate |
| Regulation Name | Spinal intervertebral body fixation orthosis |
| Regulation Number | 21 CFR 888.3060 |
| Product Code | KWQ |
| Regulatory Class | Class II |

#### Predicate or legally marketed devices which are substantially equivalent 3.

- U&I Corporation: Maxima™ Anterior Cervical Plate System (K061002)
- Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K031276)
- Medtronic: ZEPHIR™ Anterior Cervical Plate System(K994239, K030327)
- L&K BIOMED: LEXUS Anterior Cervical Plate System (K113509)
- DepuySpine:SKYLINE Anterior Cervical Plate System (K103491)

#### 4. Description of the Device

The VAN GOGH Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the VAN GOGH Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable self-tapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.

VAN GOGH Anterior Cervical Plate System

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# K121078

### 5. Intended use

The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin . withdegeneration of the disc confirmed by patient history and radiographic studies).

- . spondy lolisthesis,
- . trauma (i.e. fractures or dislocations),
- . tumors,
- . deformity (defined as kyphosis, lordosisor scoliosis),
- . pseudarthrosis.
- . failed previous fusion,
- . spinal stenosis.

#### 6. Comparison of the Technology Characteristics

The VAN GOGH Anterior Cervical Plate System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials, substantially equivalent performance characteristics and the same intended use.

#### 7. Discussion of the Non-Clinical Testing

Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the VAN GOGH Anterior Cervical Plate System performs as well as the predicate device.

#### 8. Conclusion

The VAN GOGH Anterior Cervical Plate System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Accel SPINE, LLC % Mr. Daniel Chon Vice President 14850 Quorum Drive, Suite 220 Dallas, Texas 75254

Re: K121078

Trade/Device Name: VAN GOGH 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: August 31, 2012 Received: September 4, 2012

Dear Mr. Chon:

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

SEP 13 2012

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# Page 2 - Mr. Daniel Chon

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Milliken

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

Enclosure

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AccesSPINE

# Indications for Use Statement

# 510(k) Number (if known): K121078

Device Name: VAN GOGH Anterior Cervical Plate System

#### Indications For Use:

The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,

(Part 21 CER801 Subpart D)

- deformity (defined as kyphosis, lordosisor scoliosis),
- pseudarthrosis,
- failed previous fusion, .
- spinal stenosis.

AND/OR Prescription Use

(21 CER801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (OED)

signature

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

510(k) Number K/2/078

VAN GOGH Anterior Cervical Plate S

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