MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM

K080790 · Theken Spine, LLC · KWP · Apr 29, 2008 · Orthopedic

Device Facts

• Record ID: K080790
• Device Name: MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
• Applicant: Theken Spine, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Apr 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows: Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Spinal Stenosis Fracture/Dislocation Tumors Pseudoarthrosis Revision of previous cervical and upper thoracic spine surgery The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

Device Story

The Atoll Cervico-Thoracic System is a posterior spinal fixation system consisting of titanium alloy screws, hooks, rods, and connectors. It is used by surgeons in an operating room setting to stabilize the cervico-thoracic spine (C1-T3) to promote fusion. The system components are implanted to provide mechanical stabilization following trauma, fracture, or degenerative conditions. The device allows for configuration flexibility to match patient anatomy. It can be linked to the Theken Coral Spinal System via transitional rods and connectors. The system provides structural support to the spine, facilitating the fusion process and potentially reducing pain and improving stability for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from medical implant grade titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3. System includes screws, hooks, rods, and connectors. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients requiring spinal fusion in the cervico-thoracic region (C1-T3) for degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, tumors, pseudoarthrosis, or revision of previous surgery. Screws are restricted to T1-T3 thoracic use only; not for cervical spine use.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Atoll Cervico-Thoracic System (K070638)

Reference Devices

• Synthes (USA) - CerviFix System (K990965)
• Starlock System
• Interpore Cross International - Altius OCT System (K033961)

Submission Summary (Full Text)

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Theken Spine, LLC

Atoll Cervico-Thoracic System

K08079 o
3/17/2008

## 510(K) Summary (21 CFR Part 807.92)

## Submitter Information A

APR 2 9 2008

| Submitter's Name: | Theken Spine, LLC | APR 29 2008 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | 1800 Triplett Blvd.<br>Akron, Ohio 44306 | |
| Telephone Number: | 330-475-8600 | |
| Fax Number: | 330-773-7697 | |
| Contact Person: | Dale Davison | |
| Date Prepared: | 17 March 2008 | |
| B. Device Information | | |
| Trade Name: | Atoll™ Cervico-Thoracic System | |
| Common Name: | Posterior Cervical Instrumentation | |
| Classification: | Class II System with the corresponding product codes:<br>KWP 888.3050 - Spinal Interlaminal Fixation Orthosis<br>MNI 888.3070(b)(1) - Pedicle Screw Spinal System | |
| Predicate Device: | Theken - Atoll Cervico-Thoracic System (K070638) | |
| Comparable Device: | Synthes (USA) - CerviFix System (K990965)/Starlock System<br>Interpore Cross International - Altius OCT System (K033961) | |
| Material Composition: | Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 | |
| Subject Device Description: | The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.<br><br>The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.<br><br>To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.<br><br>The purpose of this submission is to add transition rods and rod connectors | |

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Intended Use:

The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

- Degenerative Disc Disease (as identified by neck or . back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- Spinal Stenosis .
- Fracture/Dislocation .
- Tumors .
- Pseudoarthrosis .
- Revision of previous cervical and upper thoracic spine ● surgery

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

## C. Substantial Equivalence

The characteristics of the Atoll Cervico-Thoracic System are similar to the following predicate devices:

- 1. Atoll Cervico-Thoracic System (K070638) manufactured by Theken Spine and cleared by the FDA on May 30", 2007.
Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices. Therefore, Theken Spine believes that there is sufficient evidence to conclude that the Atoll Cervico-Thoracic System is substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with flowing lines, representing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2008

Theken Spine % Mr. Dale Davison Vice President of Engineering 1800 Triplett Blvd Akron, OH 44306

K080790 Re:

Trade/Device Name: Theken Atoll Cervico-Thoracic System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: April 10, 2008 Received: April 11, 2007

Dear Mr. Davison:

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. Dale Davison

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 N Millman

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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## Indications for Use

510(k) Number (if known):

Device Name: AtollTM Cervico-Thoracic System

Indications For Use:

The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervicothoracic regions of the spine (C1 - T3). The intended indications are as follows:

- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin . with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation .
- Tumors .
- Pseudoarthrosis .
- Revision of previous cervical and upper thoracic spine surgery .

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil A.Olsen for

Division of General, Restorative, and Neurological Devices

510(k) Number K080790

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