(90 days)
Not Found
No
The description focuses on the mechanical and material properties of a spinal implant system and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is a vertebral body replacement system intended to treat collapsed, damaged, or unstable vertebral bodies due to tumor or trauma.
No
This device is a vertebral body replacement system, an implantable medical device used for surgical correction and stabilization of the spine, not for diagnosing conditions.
No
The device description explicitly states the device is made of titanium alloy, cobalt chrome, and nitinol, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to replace vertebral bodies in the spine due to tumor or trauma. This is a therapeutic device used in vivo (within the body).
- Device Description: The device description details the materials and mechanics of a physical implantable system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
T2 XVBR™ Spinal System
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-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 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.
T2 ALTITUDE™ Expandable Corpectomy System
The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T)-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
T2 XVBR™ Spinal System
The T2 XVBR™ Spinal System is a distractible system. 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 standalone 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 XVBR™ expandable centerpiece is made of titanium alloy. cobalt chrome, and nitinol. The T2 XVBR™ Titanium Alloy end caps are attached to the T2 XVBR™ expandable centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The T2 XVBR™ Spinal System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.
T2 XVBRTM Spinal System constructs may not be used with stainless steel supplemental fixation devices. One of the following Medtronic spinal systems or their successors must be used with the T2 XVBRTM Spinal System.
| Anterior | Posterior | |
|---|---|---|
| ZPLATE-II™ Anterior Fixation System | x | |
| DYNA-LOK CLASSIC® Spinal System | x | x |
| VANTAGE® Anterior Fixation System | x | |
| TSRH® Spinal System | x | x |
| CD HORIZON® Spinal System | x | x |
Do not use implant components from any other manufacturer with the T2 XVBRTM Spinal System. Stainless steel and titanium implants are not compatible with each other. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
T2 ALTITUDE™ Expandable Corpectomy System
The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system. This device is inserted between two vertebral bodies in the thoracic and lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. The device is not intended to be used as a stand-alone implant.
One of the following Medtronic Spinal System or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System.
| Anterior | Posterior | |
|---|---|---|
| VANTAGE® Anterior Fixation System | x | |
| TSRH® Spinal System | x | x |
| CD HORIZON® Spinal System | x | x |
Do not use implant components from any other manufacturer with T2 ALTITUDE™ Expandable Corpectomy System components. Stainless steel and titanium implants are not compatible with each other. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
The T2 ALTITUDE™ Expandable Corpectomy System is made of titanium alloy, cobalt chrome, and nitinol. The optional T2 ALTITUDE™ angled end caps may be attached to the T2 ALTITUDE™ expanding centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The T2 ALTITUDE™ Expandable Corpectomy System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (TI-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)
The purpose of this bundled 510(k) application is to provide appropriate MRI safety labeling for the subject devices, while also providing MRI technologist with a method of concluding whether an MRI scan can be performed on the device and specific instructions on how to perform the scan. The systems in this 510(k) submission have been determined to be MR conditional per ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
In accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" testing has been completed. The following standards were followed to provide a determination that the subject devices in this 510(k) submission are MR Conditional in 1.5 Tesla and 3.0 Tesla MR environment:
- t ASTMF2052 - "Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment"
- . ASTM F2182 - "Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging."
- ASTM F2213 "Standard test method for measurement of magnetically - induced torque on medical devices in the magnetic resonance environment."
- ASTM F2119 "Standard test method for evaluation of MR image o artifacts from passive implants."
- o ASTM F2503 - "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment"
Non-clinical testing in accordance with the standards listed above was completed along with a risk analysis. Based on the test results and additional supporting documentation provided within this pre-market notification, Medtronic believes that the subject devices demonstrate substantial equivalence to the listed predicate devices and should be labeled as MR Conditional in accordance with ASTM F2503 - "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KI31888 Page 1 of 4
510(k) SUMMARY Medtronic Sofamor Danek MRI Update for T2 XVBR™ Spinal System & T2 ALTITUDE™ Expandable Corpectomy Systems
June 2013
SEP 23 2013
I. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, Tennessee 38132 (901)396-3133 ll. Contact: Becky Ronner Regulatory Affairs Specialist Telephone: (901)399-2757 Fax: (901)346-9738 111. Proprietary Trade Name: T2 XVBR™ Spinal System T2 ALTITUDE™ Expandable Corpectomy System
IV. Common & Classification Names:
Class:
Product Code:
V. Description:
T2 XVBR™ Spinal System
The T2 XVBR™ Spinal System is a distractible system. 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 standalone 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.
Spinal Intervertebral Body Fixation
· Orthosis (21 CFR 888.3060)
Class II
MQP
The T2 XVBR™ expandable centerpiece is made of titanium alloy. cobalt chrome, and nitinol. The T2 XVBR™ Titanium Alloy end caps are attached to the T2 XVBR™ expandable centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The T2 XVBR™ Spinal System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.
1
T2 XVBRTM Spinal System constructs may not be used with stainless steel supplemental fixation devices. One of the following Medtronic spinal systems or their successors must be used with the T2 XVBRTM Spinal System.
| Anterior | Posterior | |
|---|---|---|
| ZPLATE-II™ Anterior Fixation System | x | |
| DYNA-LOK CLASSIC® Spinal System | x | x |
| VANTAGE® Anterior Fixation System | x | |
| TSRH® Spinal System | x | x |
| CD HORIZON® Spinal System | x | x |
Do not use implant components from any other manufacturer with the T2 XVBRTM Spinal System. Stainless steel and titanium implants are not compatible with each other. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
T2 ALTITUDE™ Expandable Corpectomy System
The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system. This device is inserted between two vertebral bodies in the thoracic and lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. The device is not intended to be used as a stand-alone implant.
One of the following Medtronic Spinal System or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System.
| Anterior | Posterior | |
|---|---|---|
| VANTAGE® Anterior Fixation System | x | |
| TSRH® Spinal System | x | x |
| CD HORIZON® Spinal System | x | x |
Do not use implant components from any other manufacturer with T2 ALTITUDE™ Expandable Corpectomy System components. Stainless steel and titanium implants are not compatible with each other. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
The T2 ALTITUDE™ Expandable Corpectomy System is made of titanium alloy, cobalt chrome, and nitinol. The optional T2 ALTITUDE™ angled end caps may be attached to the T2 ALTITUDE™ expanding centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
2
The T2 ALTITUDE™ Expandable Corpectomy System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.
Indications for Use: VI. T2 XVBR™ Spinal System
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-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 XVBRTM 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 SCEPTORTM 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.
T2 ALTITUDE™ Expandable Corpectomy System
The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T)-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
VII. Summary of Technological Characteristics:
The purpose of this bundled 510(k) application is to provide appropriate MRI safety labeling for the subject devices, while also providing MRI technologist with a method of concluding whether an MRI scan can be performed on the device and specific instructions on how to perform the scan. The systems in this 510(k) submission have been determined to be MR conditional per ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
3
The design/specifications of the subject devices are not being addressed. No changes have occurred for the devices in the subject product families, which are considered substantially equivalent to and previously cleared under previous 510(k) submissions such as:
- . T2 XVBR™ Spinal System K091883 (S.E. 09/21/2009)
- T2 ALTITUDE™ Expandable Corpectomy System · . K100976 (S.E. 10/21/2010)
VIII. Discussion of Non-Clinical Testing:
In accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" testing has been completed. The following standards were followed to provide a determination that the subject devices in this 510(k) submission are MR Conditional in 1.5 Tesla and 3.0 Tesla MR environment:
- t ASTMF2052 - "Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment"
- . ASTM F2182 - "Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging."
- ASTM F2213 "Standard test method for measurement of magnetically � induced torque on medical devices in the magnetic resonance environment."
- ASTM F2119 "Standard test method for evaluation of MR image o artifacts from passive implants."
- o ASTM F2503 - "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment"
IX. Conclusion:
Non-clinical testing in accordance with the standards listed above was completed along with a risk analysis. Based on the test results and additional supporting documentation provided within this pre-market notification, Medtronic believes that the subject devices demonstrate substantial equivalence to the listed predicate devices and should be labeled as MR Conditional in accordance with ASTM F2503 - "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment".
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2013
Medironic Sofamor Danek USA. Incorporated Ms. Becky Ronner Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K131888
Trade/Device Name: T2 XVBR™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 24, 2013 Received: June 25, 2013
Dear Ms. Ronner:
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. Please note: CDRH does not evaluate information related to contract fiability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 complics 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
5
Page 2 - Ms. Becky Ronner
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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Reportal?roblem/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/Resources/orYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm161497.htm
Sincerely yours.
Erin | Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: T2 XVBR™ Spinal System
Indications for Use:
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-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 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 II™ 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.
AND/OR Prescription Use × (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
7
510(k) Number (if known): __ K131888
Device Name: T2 ALTITUDE® Expandable Corpectomy System
Indications for Use:
The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
× AND/OR Prescription Use (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices