Cervical and Thoracolumbar
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-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 Corpectorny System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed 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 single 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 thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collabsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratoshere™ Expandable Corpectorny 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 thoracic and lumbar 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 bone graft as an adjunct to fusion. When used in the thoracic and lumbar spine, the 72 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectory 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.

Thoracolumbar
The T2 Stratosphere™ Expandable Corpectory System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-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 thoracic and lumbar spine.

The T2 Stratosphere™ Expandable Corpectory 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 thoracic and lumbar 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 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 may be used in the thoracolumbar and cervical spine. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. Only the 13mm devices are cleared for both cervical and thoracolumbar region of the spine.

The 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 device may be implanted through a lateral, oblique, or posterior approach using a minimally invasive technique or implanted through a lateral, oblique, posterior, or anterior approach through a traditional open technique.

The T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation cleared for use in the cervical and thoracolumbar spine. The device is not intended to be used as a stand-alone implant.

The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy (TI6A14V) in accordance with ASTM F136 Standard Specification for Wrought Titanium- Aluminium-4 Vanadium ELI Alloy for Surgical Implant Applications. The centerpieces are available in multiple diameters and heights. The system also features modular end caps which are available in various angles and geometries.

AI/ML Overview

The medical device in question is the Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System. It's a vertebral body replacement device used in the thoracic, lumbar, and cervical spine. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study to prove performance as would be expected for a novel device or a PMA submission with clinical trials.

The assessment of the acceptance criteria and study proving the device meets them is based on the information provided in the 510(k) summary, which mainly references non-clinical testing performed on predicate devices and biocompatibility testing on the subject device.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (from 510(k) Summary)
Biocompatibility	Meets requirements for permanent implants (>30 days) and body-contacting devices. Manufactured from identical materials (Titanium Alloy Per ASTM F136) as predicate devices (K181328, K173125). Manufacturing processes are standard industry practices and identical to predicates 1 and 2.
Mechanical Testing	Implants are the same as predicate implants in terms of material, sizes, and intended use. Mechanical testing for predicate implants was conducted in accordance with ASTM F2077 (Test Methods For Intervertebral Body Fusion Devices) and ASTM Draft Standard F-04.25.02.02 (Static Push-out Test Method for Intervertebral Body Fusion Devices). The subject devices do not introduce a new worst-case scenario, implying they meet the same mechanical performance standards as the predicates.
Pyrogenicity	Bacterial endotoxin test (LAL test) performed on worst-case subject implants. Confirmed to meet the 20 endotoxin units (EU)/device pyrogen limit specification for general medical devices that are implanted, as outlined in ANSI/AAMI ST72 and USP <161>.

Study Information

The 510(k) summary for the T2 STRATOSPHERE™ Expandable Corpectomy System primarily relies on a demonstration of substantial equivalence to predicate devices, rather than a standalone clinical study with a test set of patients. Therefore, many of the typical clinical study parameters (sample size for test set, expert qualifications, adjudication, MRMC study, standalone performance) are not directly applicable in the way they would be for a de novo or PMA submission.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set. The performance data presented are primarily non-clinical (biocompatibility, mechanical, pyrogenicity).
- Data Provenance: The biocompatibility and pyrogenicity tests were performed on "worst-case subject implants." The mechanical testing data is "provided in the Predicate 2 (K173125, S.E 12/20/2017) submission" and "testing conducted on the predicate implants satisfies testing requirements for the subject devices." This means the mechanical data is retrospective from previous submissions. Specific country of origin for the studies is not mentioned but is implied to be in compliance with U.S. standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there was no clinical test set requiring expert ground truth establishment for this 510(k) summary. The regulatory review is based on non-clinical data and comparison to predicates.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there was no clinical test set requiring adjudication.
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 device is a surgical implant, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a surgical implant. The performance assessed is mechanical strength, material compatibility, and sterility, which are inherent properties of the device, not an algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Standardized material specifications (ASTM F136) and biological evaluation guidelines (FDA's Draft Guidance for ISO-10993).
- For mechanical properties: Standardized test methods (ASTM F2077, ASTM Draft Standard F-04.25.02.02) that define acceptable mechanical performance for intervertebral body fusion devices.
- For pyrogenicity: Standardized limits for bacterial endotoxin (20 EU/device) as per ANSI/AAMI ST72 and USP <161>.
The sample size for the training set:
- Not applicable in the context of a clinical training set for this device submission. The device design and manufacturing processes are based on established knowledge and previous predicate devices.
How the ground truth for the training set was established:
- Not applicable. The design and manufacturing are based on engineering principles, materials science, and established regulatory standards for similar devices, rather than a "training set" with ground truth in the AI/clinical study sense.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.

January 16, 2019

Medtronic Sofamor Danek, USA Inc. Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

Re: K183510

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: December 13, 2018 Received: December 18, 2018

Dear Ms. Hamilton:

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

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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,

Melissa Hall -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K183510

Device Name

T2 Stratosphere™ Expandable Corpectomy System

Indications for Use (Describe)

Cervical and Thoracolumbar

The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183510

Device Name

T2 Stratosphere™ Expandable Corpectomy System

Indications for Use (Describe)

Thoracolumbar

The T2 Stratosphere™ Expandable Corpectory System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-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 thoracic and lumbar spine.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) SUMMARY

MEDTRONIC T2 STRATOSPHERE™ Expandable Corpectomy System

December 2018

Submitter:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact Person	Elizabeth HamiltonRegulatory Affairs SpecialistDirect Telephone: (901) 399-3395
Date Prepared	December 13, 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
Predicate Devices	There are three (3) Predicates:Primary Predicate 1 - T2 Stratosphere™ Expandable Corpectomy System(K181328, S.E. 09/19/2018)Predicate 2 - T2 Stratosphere™ Expandable Corpectomy System (K173125,S.E. 12/20/2017)Predicate 3 -T2 XVBR™ System (K071033. S.E. 08/14/2007)
Description ofDevices	The T2 STRATOSPHERE™ Expandable Corpectomy System is anadjustable vertebral body replacement device and features a self-adjusting endcap which provides continuous angulation between 0-8° in any direction toaccommodate the patient's anatomical requirements.The T2 STRATOSPHERE™ Expandable Corpectomy may be used in thethoracolumbar and cervical spine. The T2 STRATOSPHERE™ ExpandableCorpectomy devices for use in the cervical spine are restricted to 13mm
	diameter centerpieces. Only the 13mm devices are cleared for both cervicaland thoracolumbar region of the spine.
	The device is inserted between two vertebral bodies in the thoracolumbar orcervical spine and is expanded to aid in the surgical correction andstabilization of the spine. The device may be implanted through a lateral,oblique, or posterior approach using a minimally invasive technique orimplanted through a lateral, oblique, posterior, or anterior approach througha traditional open technique.
	The T2 STRATOSPHERE™ Expandable Corpectomy System is intended tobe used with supplemental fixation cleared for use in the cervical andthoracolumbar spine. The device is not intended to be used as a stand-aloneimplant.
	The T2 STRATOSPHERE™ Expandable Corpectomy System is madeof titanium alloy (TI6A14V) in accordance with ASTM F136Standard Specification for Wrought Titanium- Aluminium-4 Vanadium ELIAlloy for Surgical Implant Applications. The centerpieces are availablein multiple diameters and heights. The system also features modular endcaps which are available in various angles and geometries.
Indications for Use	TL Indications
	The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebralbody replacement system intended for use in the thoracolumbar spine (T1-L5)to replace a collapsed, damaged, or unstable vertebral body due to tumor, ortrauma (i.e.; fracture). The T2 STRATOSPHERE™ Expandable Centerpiecemay be used with or without optional modular end caps which accommodateindividual anatomic requirements. The device is to be used with supplementalfixation cleared for use in the thoracolumbar spine.T2 STRATOSPHERE™ Expandable Corpectomy System is intended for usewith autograft or allograft, as an adjunct to fusion. The T2 STRATOSPHERE™Expandable Corpectomy System is also intended to restore the integrity of thespinal column even in the absence of fusion for a limited time in patients withadvanced stage tumors involving the thoracolumbar spine in whom lifeexpectancy is of insufficient duration to permit achievement of fusion, with bonegraft used at surgeon's discretion.
	Cervical Indications
	The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebralbody replacement system intended for use in the thoracolumbar spine (T1-L5)and cervical spine (C2-C7). The T2 STRATOSPHERE™ ExpandableCorpectomy System is intended for use in skeletally mature patients.
	When used in the cervical spine, the T2 STRATOSPHERE® ExpandableSystem is used to replace a collapsed, damaged, or unstable vertebral bodycaused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstructionfollowing corpectomy performed to achieve decompression of the spinal cordand neural tissues in cervical degenerative disorders. When used in the cervicalspine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not beused with optional modular end caps. When used in the cervical spine at one ortwo levels, the T2 STRATOSPHERE™ Expandable Corpectomy System isintended to be used with supplemental fixation for use in the cervical spine.When used at more than two levels, supplemental fixation should includeposterior fixation cleared for use in the cervical spine.When used in the thoracolumbar spine, the T2 STRATOSPHERE® ExpandableSystem is used to replace a collapsed, damaged, or unstable vertebral body dueto tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ ExpandableCorpectomy System may be used with or without optional modular end capswhich accommodate individual anatomic requirements. The device is to be usedwith supplemental fixation cleared for use in the thoracolumbar spine.When used in the cervical spine, the T2 STRATOSPHERE™ ExpandableCorpectomy System is intended for use with autograft or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft as an adjunct tofusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™Expandable Corpectomy System is intended for use with autograft or allograftas an adjunct to fusion. The T2 STRATOSPHERE™ Expandable CorpectomySystem is also intended to restore the integrity of the spinal column even in theabsence of fusion for a limited time in patients with advanced stage tumorsinvolving the cervical and/or thoracolumbar spine in whom life expectancy is ofinsufficient duration to permit achievement of fusion, with bone graft used at thesurgeon's discretion.
Comparison ofTechnologicalCharacteristics withthe PredicateDevices	T2 STRATOSPHERE™ Expandable Corpectomy System ImplantsThe subject T2 STRATOSPHERE™ Expandable Corpectomy System Implantshave identical: indications for use, intended use, material (Titanium Alloy PerASTM F136), levels of attachment, fundamental scientific technology andsimilar design as the T2 STRATOSPHERE™ Expandable Corpectomy devicespreviously cleared by the FDA in K181328, S.E. 09/19/2018 and K173125, S.E.12/20/2017. The subject devices are identical to the predicates cleared withinthe T2 STRATOSPHERE™ Expandable Corpectomy system in terms ofmaterial, intended use, level of attachment, size range, material andfundamental scientific technology. The subject devices are very similar indesign to the predicate devices and the only technological difference betweenthe subject and predicate T2 Stratosphere™ Expandable Corpectomy Systemimplants is the subject T2 STRATOSPHERE™ devices are provided sterile
	while the predicate T2 STRATOSPHERE™ devices are provided non-sterile.Additionally, the subject T2 STRATOSPHERE™ Expandable CorpectomySystem Implants are provided sterile and are identical to that of Predicate 3cleared by the FDA in K071033. S.E. 08/14/2007. The sterilization method usedfor the subject devices is identical to the sterilization method used for Predicate3T2 XVBRT™ System (K071033. S.E. 08/14/2007).
Performance Data	The following information is provided in support of substantial equivalence.
	BiocompatibilityThe subject, T2 STRATOSPHERE™ Expandable Corpectomy System Implantsare permanent implants(>30days) and will be classified as body contactingdevices according to FDA's Draft Guidance for Industry and FDA Staff "Use ofInternational Standard ISO-10993, Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing within risk management process." The subjectimplants are manufactured from identical materials as the predicate devices(K181328, S.E. 08/19/2018 and K173125, S.E. 12/20/2017) in accordance withthe following standards:ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications The manufacturing processes performed on the subject implants are standardindustry practices and are identical to the predicates 1 and 2.
	Mechanical TestingThe subject implants are the same as the predicate implants in terms ofmaterial, sizes and intended use. Mechanical testing for the predicate implantswere tested in accordance with the following standards:
	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 Staff
	Therefore, non-clinical mechanical testing was not performed on the Subjectsterile implants. Detailed Mechanical Testing information is provided in thePredicate 2 (K173125, S.E 12/20/2017) submission. The subject devices do notintroduce a new worst case, hence Medtronic believes that testing conducted onthe predicate implants satisfies testing requirements for the subject devices. Thesubject devices do not introduce a new worst case scenario and are substantiallyequivalent to the predicate devices.
Pyrogenicity
	The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL)test, was performed utilizing worst case subject implants to verify that thesubject implants meet the 20 endotoxin units (EU)/device pyrogen limitspecification. Testing was successfully performed, and it was confirmed that the
	subject implants meet the 20 EU/device testing limit for general medical devicesthat are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test
	methods, routine monitoring, and alternatives to batch testing and USP <161>,
	Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Conclusion
	Based on the test results and additional supporting information provided in
	this premarket notification, Medtronic believes the subject devices are
	substantially equivalent to the the legally marketed predicate devices:
	Primary Predicate 1 - T2 STRATOSPHERE™ ExpandableCorpectomy System, (K181328 S.E. 08/19/2018) Predicate 2 - T2 STRATOSPHERE™ Expandable CorpectomySystem, (K181328 S.E. 08/19/2018) Predicate 3 - T2™ XVBR Spinal System (K071033, S.E.08/14/2007)

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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.