The T2TM Spinal System is a vertebral body replacement system 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 T2TM components consist of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBRTM and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended to be used with allograft and/or autograft.

Device Description

The T2TM Spinal System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a stand alone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization.

The T2 TM Spinal System contains an expandable centerpiece, which is made of titanium alloy, cobait chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2™ Spinal System's end caps are attached to the T2™ Spinal System's expandable centerpieces to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

T2TM Spinal System constructs may not be used with stainless steel supplemental fixation devices. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2TM Spinal System.

AI/ML Overview

The provided text K091883 for the T2™ Spinal System describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or any other details related to proving the device meets specific performance criteria.

This document is a 510(k) summary, which is typically focused on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety and effectiveness. It often refers to prior clearances and may not detail new, independent performance studies beyond what was sufficient for proving substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

The following information is missing from the provided document:

Table of acceptance criteria and reported device performance: This document does not specify any quantitative acceptance criteria or provide performance data against such criteria.
Sample size used for the test set and data provenance: No test sets or their characteristics are mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no test sets are described.
Adjudication method for the test set: Not applicable as no test sets are described.
Multi-reader multi-case (MRMC) comparative effectiveness study: No mention of an MRMC study or effect size.
Standalone (algorithm-only) performance: Not applicable as this is a physical spinal system, not an algorithm.
Type of ground truth used: Not applicable as no performance studies are detailed.
Sample size for the training set: Not applicable as no training sets are described for an algorithm.
How the ground truth for the training set was established: Not applicable as no training sets are described for an algorithm.

Summary

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K691883

T2TM Spinal System .510(k) Summary June 2009

Company:

TIL.

SEP'2 1 2009

Medtronic Sofamor Danek, Inc. 1800 Pvramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

Contact:

Theresa Leister Sr. Regulatory Affairs Specialist

II. Product Name: Classification:

T2TM Spinal System MQP

Description: The T2TM Spinal System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a stand alone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization.

	Anterior	Posterior
ZPLATE-II™ Anterior Fixation System	√
DYNALOK CLASSIC® Spinal System	√	√
VANTAGE® Anterior Fixation System	√
TSRH® Spinal System	√	√
CD HORIZON® Spinal System	√

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Indications for Use: The T2TM Spinal System is a vertebral body replacement system 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 T2TM components consist of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBRTM and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended to be used with allograft and/or autograft.

Substantial Equivalence: Documentation was provided which demonstrated that the T2TM Spinal System components are substantially equivalent to previously cleared devices such as the T2 XVBRTM Spinal System K082112 (SE 08/27/2008) and the T2 SCEPTORTM Spinal System K063491 (SE 3/5/2007).

C2009 Medtronic Sofamor Danek

גר

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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 and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

SEP 2 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA. Inc. % Ms. Theresa Leister Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K091883

Trade/Device Name: T2™ Spinal System Regulation Number: 21CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 23, 2009 Received: June 24, 2009

Dear Ms. Leister:

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 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 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.

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Page 2 - Ms. Theresa Leister

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director -Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K091883

Device Name: T2TM Spinal System

Indications for Use:

The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM XVBR system consists of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IITM Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended to be used with allograft and/or autograft.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Per 21 CFR 801.109

Over-The-Counter Use

Kareem S. Barry for MXM
(Division Sign-Off)

Division of Surgical, Orthopedie, and Restorative Devices

510(k) Number K091883

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.