T2 STRATOSPHERE™ Expandable Corpectomy System

K173125 · Medtronic Sofamor Danek · MQP · Dec 20, 2017 · Orthopedic

Device Facts

• Record ID: K173125
• Device Name: T2 STRATOSPHERE™ Expandable Corpectomy System
• Applicant: Medtronic Sofamor Danek
• Product Code: MQP · Orthopedic
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Vertebral body replacement system; consists of expandable centerpieces, modular end caps, and surgical instruments. Used in thoracolumbar spine (T1-L5) to replace unstable/collapsed vertebrae due to trauma or tumor. Implanted by surgeons during spinal procedures; requires supplemental fixation. Restores spinal column integrity; supports bone graft (autograft/allograft) for fusion or palliative stabilization in advanced tumor cases. Provides mechanical support to spinal column; benefits patients by stabilizing spine and restoring structural integrity.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static compression, compression fatigue, static torsion, torsion fatigue, and expulsion testing per ASTM F2077 and ASTM Draft Standard F-04.25.02.02. All tests met pre-determined acceptance criteria.

Technological Characteristics

Expandable vertebral body replacement system; materials similar to predicates. Mechanical testing performed per ASTM F2077 and ASTM Draft Standard F-04.25.02.02. Classified as MR-Conditional. System includes centerpieces, modular end caps, and associated surgical instruments.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Intended for use with autograft/allograft as an adjunct to fusion, or for spinal column integrity restoration in patients with advanced stage tumors where fusion is not feasible due to limited life expectancy.

Regulatory Classification

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.

Predicate Devices

• T2 ALTITUDE™ Expandable Corpectomy System (K100976)
• Aesculap HydroLift VBR (K083186)
• T2 XVBR™ Spinal System (K071033)
• VERTE-STACK Spinal System® (K052931)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) SUMMARY

# MEDTRONIC T2 STRATOSPHERE™ Expandable Corpectomy System

## December 2017

| 1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Submitter:<br>Telephone: [phone]<br>Fax: [phone]<br>Kanesha Hines<br>Regulatory Affairs Specialist<br>Contact Person<br>Direct Telephone: [phone]<br>Date Prepared<br>December 7, 2017<br>T2 STRATOSPHERE™ Expandable Corpectomy System<br>Name of Device<br>Common Name<br>Spinal intervertebral body fixation orthosis<br>Classification Name<br>Spinal intervertebral body fixation orthosis: 21 CFR 888.3060<br>Class II<br>Classification<br>Product Codes<br>MQP 21 CFR 888.3060<br>There are 4 Predicates.<br>Primary Predicate 1- T2 ALTITUDE™ Expandable<br>Corpectomy System (K100976, S.E. 10/21/2010)<br>Predicate 2- Aesculap HydroLift VBR (K083186, S.E.<br>03/04/2010)<br>Predicate Devices<br>Predicate 3- T2 XVBR™ Spinal System (K071033, S.E.<br>08/14/2007)<br>Predicate 4- VERTE-STACK Spinal System® (K052931, S.E.<br>11/16/2005) | | Medtronic Sofamor Danek |
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| | | 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™ Expandable<br>Corpectomy 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 of<br>Technological<br>Characteristics with the<br>Predicate 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 | |
|…