The Pyrenees and K2M Cervical Plate Systems are 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 alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Pyrenees Cervical Plate System, Semi-constrained Screw." It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Equivalent to or better than predicate devices in ASTM F1717 testing.	The Pyrenees Cervical Plate System was mechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717.
Design Features	Substantially the same as predicate devices.	The design features and sizing of the components were also compared and the Pyrenees Cervical Plate System found to be substantially the same as these systems.
Materials	Same materials as predicate devices.	It is manufactured from the same materials (Commercially Pure titanium alloy per ASTM and ISO standards) as these systems.
Intended Use	Same intended uses as predicate devices.	It is indicated for the same intended uses as these systems: anterior screw fixation to the cervical spine (C2-C7) for 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).
Overall Equivalence	No significant differences compared to predicate devices in design, function, material, and intended use.	There are no significant differences between the Pyrenees Cervical Plate Systems currently being marketed. It is substantially equivalent to these other devices in design, function, material and intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "mechanically tested," implying physical testing, but does not provide details on the number of devices or components tested.
Data Provenance: The study is described as "mechanical testing" and "comparison to predicate systems and other currently marketed systems." This is laboratory-based testing, not human patient data. Therefore, questions of country of origin or retrospective/prospective are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study (mechanical testing for substantial equivalence of a spinal implant) does not typically involve human "experts" establishing a clinical ground truth in the way a diagnostic AI might. The "ground truth," in this case, is defined by the objective performance standards of ASTM F1717 and the characteristics of the predicate devices. The "experts" involved would be engineering and regulatory professionals performing and analyzing the mechanical tests and comparing specifications, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication for data interpretation. The "adjudication" is based on meeting the defined mechanical test standards and comparing physical and functional characteristics to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document describes a 510(k) submission for a physical medical device (spinal implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

Mechanical Performance Standards: Specifically, ASTM F1717 for mechanical testing.
Predicate Device Specifications: The documented design features, materials, and intended uses of previously cleared, legally marketed spinal plate systems.
Regulatory Definitions: The FDA's criteria for substantial equivalence under 510(k).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary for the Pvrenees Cervical Plate System, Semi-constrained Screw

This salety and effectiveness summary for the Pyrenes Cerviced as required per Section 513(i(i(3) of the Food, Drug and Cosmetic Act.

Submitter :

K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175

Date Prepared: August 10, 2009 Contact Person : Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155

MAR 1 1 2010

Tradename: Pyrenees Cervical Plate System 510(k), Semi-constrained Screw Common Name: Spinal Fixation System Spinal Intervertebral Body Fixation Orthosis (888.3060) Classification Name:

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

Pyrenees Cervical Plate System ( K2M, Inc. ) K063544 .
Cervical Spine Locking Plate (Synthes) K971883, K000536 ●
Zephir (Medtronic) K994239, K030327 ●
. Atlantis (Medtronic) K063100
EBI Anterior Cerivcal Plate System K060379 .
DePuy PEAK Polyaxial Cervical Plate System (K971730) .
Theken Surgical Tether ACFS (K010466) .

4. Description of the device :

Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

5. Intended Use:

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

The Pyrenees Cervical Plate System was mechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717. The design features and sizing of the components were also compared and the Pyrenees Cervical Plate System found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems.

There are no significant differences between the Pyrenees Cervical Plate Systems currently being marketed. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized bird or human figure with flowing lines, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR 1 1 2010

K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

Re: K092474

Trade/Device Name: Pyrenees Cervical Plate System, Semi-constrained Screw Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 08, 2010 Received: March 10, 2010

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. 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

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Page 2 - Mr. Richard W. Woods

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbara Hugh MD

Mark N. Melkers 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: K092474

Device Name: Pyrenees Cervical Plate System:, Semi-constrained Screws

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K092474 510(k) Number_

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.