MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM

K063544 · K2m, Inc. · KWQ · Feb 14, 2007 · Orthopedic

Device Facts

• Record ID: K063544
• Device Name: MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
• Applicant: K2m, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 14, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pvrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications : degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

Device Story

Pyrenees Cervical Plate System is a spinal fixation orthosis consisting of titanium plates and screws; used as an adjunct to spinal fusion to provide immobilization and stabilization of cervical spine segments (C2-C7). Device components are available in various sizes to accommodate patient anatomy. System is intended for surgical use by physicians to treat degenerative conditions, trauma, tumors, and deformities. Clinical benefit derived from stabilization of the cervical spine to facilitate fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717 to demonstrate substantial equivalence.

Technological Characteristics

Commercially pure titanium and titanium alloy components. Compliant with ASTM and ISO standards. Spinal intervertebral body fixation orthosis. Mechanical stabilization system.

Indications for Use

Indicated for anterior screw fixation to the cervical spine (C2-C7) in patients with degenerative disc disease, spondylolisthesis, trauma (fractures), spinal stenosis, tumors (primary/metastatic), pseudarthrosis, or spinal deformity (scoliosis, kyphosis, lordosis).

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

• Pyrenees Cervical Plate (K060442)
• Synthes CSLP (K971883, K000538)
• K2M, Inc. Tectonic Anterior Cervical Plate System (K051531)
• De Puy Acromed PEAK Cervical Plate System (K971730, K926486)
• Interpore Cross Anterior Cervical Plate System (K002592)

Submission Summary (Full Text)

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K063544

FFB 1 4 2007

## 510(k) Summary Pyrenees Cervical Plate System K2M, Inc.

This safety and effectiveness summary for the Pyrenees Cervical Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

#### 1. Submitter :

K2M, Inc. 751 Miller Drive SE Suite F 1 Leesburg, VA 20175

## Contact Person :

Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: [phone]

Date Prepared: November 21, 2006

#### 2. Tradename: Pyrenees Cervical Plate System Common Name: Anterior Cervical Plate Spinal Intervertebral Body Fixation Orthosis ( 888.3060 ) Classification Name:

#### 3. Description of the device:

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

- Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

#### 4. Intended Use:

The Pvrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications : degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

#### 5. Predicate or legally marketed devices which are substantially equivalent:

Testing in accordance with ASTM F1717 was performed and demonstrated that the modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592).

## 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

There are no significant differences between the Pyrenees Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K2M, Limited Liability Company c/o Mr. Richard Woods Senior Vice President 751 Miller Drive, SE, Suite F-1 Leesburg, Virginia 20175

FFB 1 4 7007

Re: K063544

> Trade/Device Name: Pyrenees Cervical Plate System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: November 21, 2006 Received: November 28, 2006

Dear Mr. Woods:

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.

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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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

for

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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## 510(k): K063544

#### Pyrenees Cervical Plate System Device Name :

# Indications For Use :

The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity ( defined as scoliosis, kyphosis or lordosis).

Prescription use >> OR

Over-the-counter use ( PER 21 CFR 801.109)

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

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Concurrence of CDRH, Office of Device Evaluation ( ODE )

**Division Sign-Of**

(Division Sign-Off) Division of General, Restorative, and Neurological I

510(k) Number