(124 days)
Not Found
No
The document describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a vertebral body replacement system used to treat collapsed, damaged, or unstable vertebral bodies caused by tumor or trauma, and it helps to decompress the spinal cord and neural tissues, which directly addresses medical conditions and provides a therapeutic effect.
No
The device is a vertebral body replacement system, an implantable medical device used for surgical correction and stabilization of the spine, not for diagnosing medical conditions.
No
The device description clearly states it is an "adjustable vertebral body replacement device" made of "titanium alloy," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The T2 STRATOSPHERE™ Expandable Corpectomy System is a physical implant designed to replace damaged vertebral bodies in the spine. Its function is mechanical support and stabilization, not diagnostic testing of biological samples.
- Lack of Diagnostic Activities: The description focuses on surgical implantation, expansion, and structural support. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the T2 STRATOSPHERE™ Expandable Corpectomy System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use in skeletally mature patients.
When used in the cervical spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or for reconstruction following corpectomned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at one or two levels, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine.
When used in the thoracolumbar spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable Corpectomy System may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.
When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes (comma separated list FDA assigned to the subject device)
MQP, PLR
Device Description
The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy. This device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available in multiple heights.
The system also features modular end caps which are available in various angles and diameters that are only for use in the thoracolumbar spine.
The device is not intended to be used as a stand-alone implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5) and cervical spine (C2-C7)
Indicated Patient Age Range
skeletally mature patients
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)
Design verification testing for the subject implants was completed in accordance with:
- ASTM F2077, Test Methods For Intervertebral Body Fusion Devices
- ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices
The tests completed were:
- Static Compression
- Compression Fatigue
- Static Torsion
- Torsion Fatigue
- Expulsion
The subject devices met the pre-determined acceptance criteria for all tests. Therefore, Medtronic believes design verification testing demonstrated that the subject implants are substantially equivalent to the predicate Medtronic devices.
MRI Testing
MRI testing was conducted in accordance with the Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. The MRI testing was submitted and cleared in the Predicate 6 (K173125, S.E. 12/20/2017) submission.
The subject and Predicate 6 Ø13mm centerpieces are identical in material and dimensions. Therefore, the subject Ø13mm centerpieces do not present a new worst case and are justifiably classified as MR-Conditional.
A clinical literature review was performed to support the use of the subject devices in the cervical spine. The risks of cervical use were identified and mitigated through design and surgical technique. Based on clinical literature, it was determined that the safety profile of the subject devices is equivalent to that of the predicate devices.
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.
K162315, K172032, K151651, K012254, K100976, K173125
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 19, 2018
Medtronic Sofamor Danek, USA Inc. Kanesha Hines Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K181328
Trade/Device Name: T2 STRATOSPHERE™ Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: August 17, 2018 Received: August 20, 2018
Dear Ms. Hines:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 liability 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181328
Device Name
T2 STRATOSPHERETM Expandable Corpectomy System
Indications for Use (Describe)
The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable Corpectorny System is intended for use in skeletally mature patients.
When used in the cervical spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at one or two levels, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine.
When used in the thoracolumbar spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable Corpectomy System may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.
When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
MEDTRONIC T2 STRATOSPHERE™ Expandable Corpectomy System
September 2018
| Submitter: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kanesha Hines
Regulatory Affairs Specialist
Direct Telephone: (901)399-2670 |
| Date Prepared | September 19, 2018 |
| Name of Device | T2 STRATOSPHERE™ Expandable Corpectomy System |
| Common Name | Spinal Vertebral Body Replacement Device |
| Classification
Name | Spinal Intervertebral Body Fixation Orthosis: 21 CFR 888.3060 |
| Classification | Class II |
| Product Codes | MQP, PLR 21 CFR 888.3060 |
| Predicate Devices | There are six (6) Predicates.
Primary Predicate 1- Globus FORTIFY CORPECTOMY
SPACERS (K162315, S.E. 11/09/2017)
Predicate 2- Aesculap MODULIFT VBR SYSTEM (K172032. S.E.
11/20/2017)
Predicate 3- - Nuvasive X-CORE MINI CERVICAL
EXPANDABLE VBR System (K151651, S.E. 09/25/2015)
Predicate 4- Osteotech VBR (K012254, S.E. 10/16/2001)
Predicate 5- Medtronic T2 ALTITUDE™ EXPANDABLE
CORPECTOMY System (K100976, S.E. 10/21/2010)
Predicate 6- Medtronic T2 STRATOSPHERE™ EXPANDABLE
CORPECTOMY System (K173125, S.E. 12/20/2017)
The predicates have not been subject to a design related recall. |
| Description of Devices | The T2 STRATOSPHERE™ Expandable Corpectomy System is
an adjustable vertebral body replacement device and features a
self-adjusting end cap which provides continuous angulation
between 0-8° in any direction to accommodate the patient's
anatomical requirements. The T2 STRATOSPHERE™
Expandable Corpectomy devices for use in the cervical spine are
restricted to 13mm diameter centerpieces. The T2
STRATOSPHERE™ Expandable Corpectomy System is made of
titanium alloy. This device is inserted between two vertebral
bodies in the thoracolumbar or cervical spine and is expanded to
aid in the surgical correction and stabilization of the spine. The
centerpieces are available in multiple heights.
The system also features modular end caps which are available
in various angles and diameters that are only for use in the
thoracolumbar spine.
The device is not intended to be used as a stand-alone implant. |
| Indications for Use | The T2 STRATOSPHERE™ Expandable Corpectomy System
is a vertebral body replacement system intended for use in the
thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The
T2 STRATOSPHERE™ Expandable Corpectomy System is
intended for use in skeletally mature patients.
When used in the cervical spine, the T2 STRATOSPHERE®
|
| When used in the thoracolumbar spine, the T2
STRATOSPHERE® Expandable System is used to replace a
collapsed, damaged, or unstable vertebral body due to tumor or
trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable
Corpectomy System may be used with or without optional
modular end caps which accommodate individual anatomic
requirements. The device is to be used with supplemental
fixation cleared for use in the thoracolumbar spine. | |
| When used in the cervical spine, the T2 STRATOSPHERE™
Expandable Corpectomy System is intended for use with
autograft or allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft as an adjunct to fusion. When used
in the thoracolumbar spine, the T2 STRATOSPHERE™
Expandable Corpectomy System is intended for use with
autograft or allograft as an adjunct to fusion. The T2
STRATOSPHERE™ Expandable Corpectomy System is also
intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time in patients with advanced
stage tumors involving the cervical and/or thoracolumbar spine
in whom life expectancy is of insufficient duration to permit
achievement of fusion, with bone graft used at the surgeon's
discretion. | |
| Comparison of
Technological
Characteristics
with the Predicate
Devices | T2 STRATOSPHERE™ Expandable Corpectomy System Implants
The primary predicate is Globus FORTIFY CORPECTOMY
SPACERS (K162315, S.E. 11/09/2017). The subject implants have
similar intended use, indications, and same materials as Primary
Predicate 1 (K162315, S.E. 11/09/2017) and Predicate 2 (K172032,
S.E. 11/20/2017). The subject and all predicate devices have similar
scientific fundamental technology. |
| | Performance Data |
| Design verification testing for the subject implants was completed in
accordance with
- ASTM F2077, Test Methods For Intervertebral Body Fusion
Devices - ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method
for Intervertebral Body Fusion Devices
The tests completed were:
- Static Compression
- Compression Fatigue
- Static Torsion
- Torsion Fatigue
- Expulsion
The subject devices met the pre-determined acceptance criteria for
all tests. Therefore, Medtronic believes design verification testing
demonstrated that the subject implants are substantially equivalent to
the predicate Medtronic devices.
MRI Testing
MRI testing was conducted in accordance with the Guidance for
Industry and FDA Staff – Establishing Safety and Compatibility of
Passive Implants in the Magnetic Resonance (MR) Environment.
The MRI testing was submitted and cleared in the Predicate 6
(K173125, S.E. 12/20/2017) submission.
The subject and Predicate 6 Ø13mm centerpieces are identical in
material and dimensions. Therefore, the subject Ø13mm centerpieces
do not present a new worst case and are justifiably classified as MR-
Conditional. | |
| Performance Data | A clinical literature review was performed to support the use of the
subject devices in the cervical spine. The risks of cervical use were
identified and mitigated through design and surgical technique.
Based on clinical literature, it was determined that the safety profile
of the subject devices is equivalent to that of the predicate devices. |
| Conclusion | Based on the test results and additional supporting information
provided in this premarket notification, Medtronic believes the
subject devices are at least as safe as and effective as the legally
marketed predicate devices:
• Primary Predicate 1- Globus FORTIFY Spacers
(K162315, S.E. 11/09/2017) |
| • Predicate 2- Aesculap MODULIFT VBR System (K172032, S.E. 11/20/2017) | |
| • Predicate 3- NuVasive X-CORE MINI (K151651, 09/25/2015) | |
| • Predicate 4- Osteotech VBR (K012254, 10/16/2001) | |
| • Predicate 5- Medtronic T2 ALTITUDE™ Expandable Corpectomy System (K100976, S.E. 10/21/2010) | |
| • Predicate 6- Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System (K173125, S.E. 12/20/2017) | |
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