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 Description

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 allov 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.

AI/ML Overview

The provided text describes a medical device, the Pyrenees Cervical Plate System, and its regulatory clearance process, including an "Indications For Use" statement. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample sizes, expert qualifications, adjudication methods, or ground truth establishment).

The document is a "Summary of Safety and Effectiveness" and a 510(k) clearance letter from the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device based on design, function, material, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other study-related details based on the provided text. The text explicitly states: "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." This language indicates a reliance on substantial equivalence rather than a new performance study with explicit acceptance criteria.

Summary

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Summary of Safety and Effectiveness for the Pyrenees Cervical Plate System

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

1. Submitter :	Contact Person :
K2M, LLC	Richard W. Woods
751 Miller Drive SE,	K2M, LLC
Suite F1	751 Miller Drive SE, Suite F1
Leesburg, VA 20175	Leesburg, VA 20175
	Telephone: 703-777-3155
Date Prepared: February 14, 2006

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

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

. Cervical Spine Locking Plate System ( Synthes )
. Tectonic Cervical Plate System (K2M, LLC)
. PEAK Anterior Cervical Plate System ( Depuy Acromed )

4. Description of the device:

Materials: The devices are manufactured from Commercially Pure Titanium and titanium allov 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.

5. Intended 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 ).

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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510(k): K060442

Device Name : Pyrenees Cervical Plate System

Indications For Use :

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 X

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

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation ( ODE )

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Page 1 of 1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

INVALE UNE

Mr. Richard W. Woods Senior Vice President K2M, LLC 751 Miller Drive SE, Suite F-1 Leesburg, VA 20175

Re: K060442

Trade/Device Name: Pyrenees Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: February 15, 2006 Received: February 23, 2006

Dear Mr. Harris:

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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Page 2 - Mr. Richard W. Woods

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Helmut Lemke

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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K060442 510(k):

Device Name : Pyrenees Cervical Plate System

Indications For Use :

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 turnors ( primary and metastatic ), failed previous fusions (pseudarthrosis ) and deformity ( defined as scoliosis, kyphosis or lordosis ).

Prescription use X OR

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

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

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Hubert Leemans

(Divis Division of General, Restorative, and Neurological Devices

510(k) Number. 060447 Page 1 of 1

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.