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 Tectonic 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 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.

AI/ML Overview

After reviewing the provided document, I cannot identify any information regarding acceptance criteria, device performance, results from a study, or details about ground truth establishment.

This document is a 510(k) Premarket Notification summary and approval letter for the Tectonic Cervical Plate System. It focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed clinical study with specific performance metrics against pre-defined acceptance criteria.

The key points from the document are:

Device: Tectonic Cervical Plate System
Intended Use: Anterior screw fixation to the cervical spine (C2-C7) for various indications (degenerative disc disease, trauma, tumors, etc.).
Comparison: The device is deemed "substantially equivalent" to predicate devices (Cervical Spine Locking Plate System, Codman Anterior Cervical Plate System, Blackstone Anterior Cervical Plate System) in design, function, material, and intended use. The document explicitly states: "There are no significant differences between the Tectonic Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product."
Regulatory Outcome: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill your request for the Acceptance Criteria, Reported Device Performance, Study Details, or Ground Truth information based on this document. Such information would typically be found in detailed clinical study reports, performance testing reports, or validation summaries, which are not part of this 510(k) summary.

Summary

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2005 7 1 1005

Summary of Safety and Effectiveness for the Tectonic Cervical Plate System

This salety and effectiveness summary for the Tectonic Cervical Plate System is provided as required per Section 513()(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: April 4, 2005

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

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

. Cervical Spine Locking Plate System ( Synthes )
. Codman Anterior Cervical Plate System (Johnson & Johnson)
. BlackstoneAnterior Cervical Plate System ( Blackstone Medical Inc. ).

4. Description of the device :

Materials: The devices are manufactured from 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.

5. Intended Use:

The Tectonic 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 mctastatic ), failed previous fusions (pscudarthrosis ) and deformity ( defined as scollosis, 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 Tectonic 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Harris Senior Project Engineer K2M, LLC 751 Miller Drive SE, Suite F-1 Leesburg, VA 20175

Re: K051531

Trade Name: Tectonic Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: August 31, 2005 Received: September 1, 2005

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.

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. Peter Harris

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,

Ser Mark N. Melkerson

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

Enclosure

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Page 1 of 1

510(k): K051531

Tectonic Cervical Plate System Device Name :

Indications For Use :

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 )

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

510(k) Number K051531

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.