(124 days)
Not Found
No
The document describes a mechanical vertebral body replacement system and does not mention any AI or ML components or functionalities.
Yes.
The device is a vertebral body replacement system used to treat conditions due to tumor or trauma, which makes it a therapeutic device.
No
Explanation: The T2TM Spinal System is described as a vertebral body replacement system intended for surgical correction and stabilization of the spine, and it is a "distractible system used in corpectomy procedures." Its function is to replace damaged or unstable vertebral bodies, not to identify or diagnose medical conditions.
No
The device description explicitly states it is a "distractible system" with components made of titanium alloy, cobalt chrome, and nitinol, which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the T2™ Spinal System is a vertebral body replacement system intended for surgical implantation in the spine. It is a physical implant used to stabilize the spine after removal of a damaged vertebral body.
- Intended Use: The intended use is to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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 T2™ components consist of a series of end caps, baskets, and covers 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 XVBRIM 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 T2™ Spinal System construct is intended to be used with bone graft.
Product codes
MQP
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, cobalt 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, baskets, and covers are attached to the T2TM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063491, K052931, K024049, K042922, K992928, K043488
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
CUNF II - N I
MEDTRONIC Sofamor Danek T2TM Spinal System 510(k) Summary April 2007
L071033
- I. Company: Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133
AUG 1 4 2007
II. Product Name: T2TM Spinal System Classification: MQP
III. 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, cobalt 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, baskets, and covers are attached to the T2TM 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.
| Anterior | Posterior | |
|---|---|---|
| ZPLATE-II™ Anterior Fixation System | √ | |
| DYNALOK CLASSIC® Spinal System | √ | √ |
| VANTAGE® Anterior Fixation System | √ | |
| TSRH® Spinal System | √ | √ |
| CD HORIZON® Spinal System | √ | √ |
1
- IV. 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 T2™ components consist of a series of end caps, baskets, and covers 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 XVBRIM 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 bone graft.
- V. Substantial Equivalence: Documentation was provided which demonstrated that the T2TM Spinal System components are substantially equivalent to previously cleared devices such as the T2TM SCEPTOR™ Spinal System K063491 (SE 3/5/2007), the VERTE-STACK® Spinal System K052931 (SE 11/16/2005), the VERTE-SPAN™M Spinal System K024049 (SE 2/26/2003), the VENTURE™ Anterior Cervical Plate System K042922 (SE 11/19/2004), the CD HORIZON® Spinal System K992928 (SE 9/21/1999) and K043488 (SE 3/22/2005).
000008
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, facing right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Metronic Sofamor Danek, Inc. % Ms. Christine Scifert Group Director, Regulatory Affairs 1800 Pyramid Place Memphis. TN 38132
Allin 2 4 2007
Re: K071033
Trade/Device Name: T2™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 11, 2007 Received: April 12, 2007
Dear Mr. Dale 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.
3
Page 2 – Mr. Dalc 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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 T2™ components consist of a series of end caps, baskets, and covers 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 DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with bone graft.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Murle A. Mulkerson
storative, and Neurological Devices
510(k) Number
000000