T2 SCEPTOR SPINAL SYSTEM

K063491 · Medtronic Sofamor Danek · MQP · Mar 5, 2007 · Orthopedic

Device Facts

• Record ID: K063491
• Device Name: T2 SCEPTOR SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: MQP · Orthopedic
• Decision Date: Mar 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T2™ SCEPTOR™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.

Device Story

Vertebral body replacement system; consists of angled/non-angled endcleats and end caps; attaches to PYRAMESH-C implants. Provides expulsion resistance by gripping inferior/superior end plates; hollow core allows bone graft placement for fusion. Used in thoracolumbar spine; requires supplemental fixation systems (e.g., ZPLATE-II, CD HORIZON, TSRH, DYNALOK, VANTAGE, GDLH). Implanted by surgeons; provides structural support for collapsed/damaged vertebrae; facilitates spinal fusion.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Commercially pure titanium or titanium alloy (ASTM F67, ASTM F136, ISO 5832-2, ISO 5832-3). Design: Angled/non-angled endcleats and end caps for attachment to PYRAMESH-C implants. Mechanical function: Expulsion resistance via end plate gripping. Form factor: Various sizes to match patient anatomy.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to collapsed, damaged, or unstable vertebral bodies caused by tumor or trauma (fracture). Must be used with PYRAMESH-C device, supplemental spinal fixation, and bone graft.

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

• VERTE-STACK® Spinal System (K052931, K060719)
• PYRAMESH-C Spinal System (K011406)

Submission Summary (Full Text)

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## MEDTRONIC Sofamor Danek T2™ SCEPTOR™ Spinal System 510(k) Summary November 2006

| I. | Company: | Medtronic Sofamor Danek, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
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MAR 0 5 2007

| II. | |
|-----------------|------------------------------------------------------|
| Product Name: | T2 ^TM SCEPTOR ^TM Spinal System |
| Classification: | MQP |

Description: The Medtronic Sofamor Danek T2™ SCEPTOR™ System is comprised III. of a set of various angled and non-angled endcleats and end caps which are affixed to the ends of the PYRAMESH-C® implants. These devices serve to grip the inferior and superior end plates, thus allowing for expulsion resistance. The pyramid-shaped openings located along the wall of the PYRAMESH-C® device allows grafting material to be placed inside the hollow core of the device to help achieve a solid fusion.

The device is made from commercially pure titanium or titanium alloy conforming to such voluntary standards as ASTM F67 and ASTM F136 or the ISO equivalents 5832-2 and 5832-3, and is available in various sizes to match the patients' anatomical requirements.

The T2™ SCEPTOR™ device, used in conjunction with the PYRAMESH-C® device, is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine. These systems include the ZPLATE-II™ Anterior Fixation System, the CD HORIZON® Spinal System, the TSRH® Spinal System, the DYNALOK™ CLASSIC Spinal System, and the Laurain DeWald Anterior Fixation System.

- Indications for Use: The T2™ System The T2™ SCEPTOR™ Spinal System is a IV. vertebral body replacement device intended for use in the thoracolumbar spine (T) -LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the
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V ANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.

- Substantial Equivalence: Documentation, including mechanical test results, provided V. has demonstrated that the T2™ SCEPTOR™ Spinal System is substantially equivalent to similar previously cleared devices such as the VERTE-STACK® Spinal System (K052931, SE 11/16/05 and · K060719, SE 04/14/06) as well as the PYRAMESH-C Spinal System (K011406, SE 12/27/01).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek c/o Ms. Christine Scifert 1800 Pyramid Place Memphis. Tennessee 38132

MAR 0 5 2007

Re: K063491 Trade Name: T2™ SCEPTOR™ Endcleat System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: January 9, 2007 Received: January 11, 2007

Dear Ms. Scifert:

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 -- Ms. Christine Scifert

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 vours,

Mark A. Milkers

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) Number (if known):

K 0 6 3 4.91

Device Name:_____ T2™ SCEPTOR™ Spinal System

## Indications for Use:

The T2™ SCEPTOR™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millhusan

Division of Ge ral, Resto and Neurological Devices

**510(k) Numb**

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