The T2 STRATOSPHERE™ Expandable Corpectomy 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 T2 STRATOSPHERE™ Expandable Centerpiece 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.

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 turnors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Device Description

The T2 STRATOSPHERE™ Expandable Corpectomy System consists of centerpieces, modular end caps, and associated instruments. The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine for tumor and trauma pathologies.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the T2 STRATOSPHERE™ Expandable Corpectomy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with strict acceptance criteria for diagnostic performance. Therefore, the information requested about acceptance criteria for diagnostic device performance (e.g., accuracy, sensitivity, specificity, MRMC studies) is generally not applicable to this kind of submission for a mechanical implantable device.

Instead, acceptance criteria for this device are related to its mechanical performance and safety. The provided text outlines:

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this device are the established standards for mechanical and MRI compatibility, which the device must meet to demonstrate substantial equivalence to its predicate devices. The "Reported Device Performance" confirms that the device met these criteria.

Category	Acceptance Criteria (Standard)	Reported Device Performance
Mechanical Testing	- ASTM F2077 (Test Methods For Intervertebral Body Fusion Devices)	The subject devices met the pre-determined acceptance criteria for all tests. This demonstrates that the subject implants are substantially equivalent to the predicate Medtronic devices in terms of mechanical performance.
	- ASTM Draft Standard F-04.25.02.02 (Static Push-out Test Method for Intervertebral Body Fusion Devices)	Specific tests completed: - Static Compression - Compression Fatigue - Static Torsion - Torsion Fatigue - Expulsion
MRI Testing	- Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment	Medtronic believes that the subject implants do not present a new worst case and thus, can justifiably be classified as MR-Conditional. (This implies that the device was evaluated against the guidance and found to meet the criteria for MR-Conditional labeling, although specific numerical performance metrics are not provided in this summary).

Information Not Applicable or Not Provided in this 510(k) Summary:

The following points are typically relevant for diagnostic devices or devices requiring clinical performance data. They are generally not applicable to a mechanical implantable device seeking 510(k) clearance based on substantial equivalence to a predicate, where mechanical and biocompatibility testing are the primary focus.

Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic performance testing. The "test set" here would refer to the mechanical specimens, which are tested in a lab, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on standardized test methods and physical measurements, not expert consensus on medical images or diagnoses.
Adjudication method for the test set: Not applicable for mechanical or MRI compatibility testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device's "performance" is based on established engineering standards for mechanical strength, durability, and MRI compatibility. This is demonstrated through in-vitro laboratory testing, not clinical "ground truth" derived from patient outcomes or expert reads.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, for the T2 STRATOSPHERE™ Expandable Corpectomy System, "acceptance criteria and study that proves the device meets the acceptance criteria" refers to the successful completion of rigorous mechanical laboratory testing and MRI compatibility testing in accordance with recognized ASTM standards and FDA guidance, demonstrating that the device performs equivalently to its legally marketed predicate devices. It is not a diagnostic device and therefore the acceptance criteria are not related to diagnostic performance metrics.

Summary

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December 20, 2017

Medtronic Sofamor Danek Ms. Kanesha Hines Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K173125

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 Dated: September 28, 2017 Received: September 29, 2017

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. 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 801); medical device 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);

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Page 2 - Ms. Kanesha Hines

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Ronald P. Jean -S for

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

Enclosure

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Indications for Use

510(k) Number (if known) K173125

Device Name

T2 STRATOSPHERE™ Expandable Corpectomy System

Indications for Use (Describe)

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

December 2017

1800 Pyramid PlaceMemphis, Tennessee 38132Submitter:Telephone: (901)396-3133Fax: (901) 346-9738Kanesha HinesRegulatory Affairs SpecialistContact PersonDirect Telephone: (901)399-2670Date PreparedDecember 7, 2017T2 STRATOSPHERE™ Expandable Corpectomy SystemName of DeviceCommon NameSpinal intervertebral body fixation orthosisClassification NameSpinal intervertebral body fixation orthosis: 21 CFR 888.3060Class IIClassificationProduct CodesMQP 21 CFR 888.3060There are 4 Predicates.Primary Predicate 1- T2 ALTITUDE™ ExpandableCorpectomy System (K100976, S.E. 10/21/2010)Predicate 2- Aesculap HydroLift VBR (K083186, S.E.03/04/2010)Predicate DevicesPredicate 3- T2 XVBR™ Spinal System (K071033, S.E.08/14/2007)Predicate 4- VERTE-STACK Spinal System® (K052931, S.E.11/16/2005)		Medtronic Sofamor Danek






















		The predicates have not been subject to a design related recall.
The T2 STRATOSPHERE™ Expandable Corpectomy System	Description of Devices
consists of centerpieces, modular end caps, and associated
instruments. The T2 STRATOSPHERE™ ExpandableCorpectomy System is intended for vertebral body replacement to
	aid in the surgical correction and stabilization of the spine for
	tumor and trauma pathologies.
	The T2 STRATOSPHERE™ Expandable Corpectomy 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 STRATOSPHERE™ Expandable Centerpiece 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.
Indications for Use	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 thoracolumbar spine in
	whom life expectancy is of insufficient duration to permit
	achievement of fusion, with bone graft used at the surgeon's
	discretion.
	T2 STRATOSPHERE™ Expandable Corpectomy System
	Implants
	The primary predicate is T2 ALTITUDE™ Expandable
	Corpectomy System (K100976, S.E. 10/21/2010). The subject
	and predicate implants have identical intended use and similar
	indications and materials as Primary Predicate 1 (K100976, S.E.
Comparison ofTechnologicalCharacteristics with thePredicate Devices	10/21/2010) and Predicate 2 K083186, S.E. 03/04/2010). The
	predicate and subject devices have identical function and similar
	scientific fundamental technology.
	T2 STRATOSPHERE™ Expandable Corpectomy System
	Instruments
	The primary predicate is T2 ALTITUDE™ Expandable
	Corpectomy System (K100976, S.E. 10/21/2010). The predicate
	and subject devices have identical function and similar scientific
	fundamental technology.
	Mechanical Testing
Performance Data
	In accordance with the Guidance for Industry and FDA Staff -
	Spinal System 510(k)'s,Medtronic has evaluated the subject
	devices to demonstrate substantial equivalence to the
	predicate devices.

	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
	In accordance with the Guidance for Industry and FDA Staff -
	Establishing Safety and Compatibility of Passive Implants in the
	Magnetic Resonance (MR) Environment, Medtronic has evaluated
	the subject devices to demonstrate substantial equivalence to the
	predicate devices. Medtronic believes that the subject implants do
	not present a new worst case and thus, can justifiably be classified
	as MR-Conditional.
	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- T2 ALTITUDE™ Expandable0
Conclusion	Corpectomy System (K100976, S.E. 10/21/2010)
	Predicate 2- Aesculap HydroLift VBR (K083186, S.E.0
	03/04/2010)
	Predicate 3- T2 XVBR™ Spinal System (K071033, S.E.0
	08/14/2007)
	Predicate 4- VERTE-STACK Spinal System® (K052931,0
	S.E. 11/16/2005)

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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.