ACCIN ANTERIOR CERVICAL PLATE SYSTEM

K073530 · Accelerated Innovation, LLC · KWQ · Jan 31, 2008 · Orthopedic

Device Facts

• Record ID: K073530
• Device Name: ACCIN ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Accelerated Innovation, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accin™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scoliosis); pseudoarthrosis; and/or failed previous fusions. The Accin™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Device Story

Accin™ Cervical Plate System consists of titanium alloy plates and self-tapping/self-drilling screws. Used by surgeons for anterior spinal fixation in the sub-axial cervical spine (C3-C7). Provides temporary stabilization to facilitate spinal fusion. Implanted during surgical procedures. Benefits patients by maintaining alignment and stability during the bone healing process.

Clinical Evidence

Bench testing only. Static and fatigue testing performed in accordance with ASTM F1717 (Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model). Results demonstrated equivalence to predicate devices.

Technological Characteristics

Titanium alloy cervical plates and screws. Self-tapping and self-drilling screw components. Mechanical testing performed per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization during fusion (C3-C7). Conditions include degenerative disc disease, trauma (fractures), tumor, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, and failed previous fusions.

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

• Vertebron SCP and SSP Cervical Plate Systems (K040003, K043181, K051815, K062110)

Submission Summary (Full Text)

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Accin™ Cervical Plate System Premarket Notification Submission - 510(k)

K073530

#### Summary of Safety and Effectiveness

| Submitter: | Michael Kvitnitsky<br>Accelerated Innovation, LLC<br>1033 US Highway 46, Suite A204<br>Clifton, NJ 07103 | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Date Prepared: | December 10, 2007 | JAN 31 2008 |
| Device: | Accin™ Cervical Plate System | |
| Classification: | 87KWQ - Appliance, Fixation, Spinal Intervertebral Body, 21CFR 880.3060,<br>Class II | |
| Predicate Device: | Vertebron SCP and SSP Cervical Plate Systems - K040003, K043181, K051815<br>and K062110 | |
| Device Description: | The Accin™ Cervical Plate System consists of titanium cervical plates and both<br>self-tapping and self-drilling screw components. The surgeon uses the<br>components to make a construct that is placed anteriorly for spinal fixation. The<br>construct is used for temporary fixation which allows for fusion of the cervical<br>spine | |
| Intended Use: | The Accin™ Cervical Plate System is intended for anterior interbody fixation of<br>the cervical spine. The system is indicated for use in the temporary stabilization<br>of the anterior spine during the development of cervical spine fusions in patients<br>with degenerative disk disease (as defined by neck pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies); trauma<br>(including fracture); tumor; deformity (defined as kyphosis, lordosis or scoliosis);<br>pseudoarthrosis; and/or failed previous fusions. The Accin™ Cervical Plate<br>System can be implanted in the sub-axial cervical spine from C3 through C7. | |

#### Comparison to Predicates:

The Accin™ Cervical Plate System consists of plates and screws manufactured from the same titanium alloy as the Vertebron, Inc. SPC and SSP Cervical Plate Systems. Therefore, the devices are equivalent to the Vertebron, Inc. SPC and SSP Cervical Plate Systems.

Accin™ has determined that any differences in the proposed device will not impact the safety or effectiveness of the cervical plate system for its intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled "Spinal System 510(k)s" dated May 3, 2004, and that the proposed device is equivalent to the predicate device.

## Synopsis of Test Methods and Results:

Tests were performed on the cervical plate system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. The proposed device was equivalent to the predicate device for all testing performed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a family of three figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2008

Accelerated Innovations, LLC % Mr. Michael Kvitnitsky Chief Operating Officer 1033 US Highway 46, Suite A204 Clifton, NJ 07103

Re: K073530

Trade/Device Name: Accin™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 12, 2007 Received: December 19, 2007

Dear Mr. Kvitnitsky:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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# Page 2 - Mr. Michael Kvitnitsky

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullens

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

Enclosure

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Accin™ Cervical Plate System Premarket Notification Submission - 510(k)

### Indications for Use Form

510(k) Number (if known):

Device Name: Accin™ Cervical Plate System

Indications for Use:

The Accin™ Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with:

- Degenerative disk disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Trauma (including fractures) .
- Tumor .
- Deformity (defined as kyphosis, lordosis or scollosis) .
- Pseudoarthrosis ●
- Failed previous fusions. .

The Accin Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Coneangince of DRH. Office

Willem Muench
Division Sign

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and Neurological Devices

510(k) Number K62530