NuVasive X-CORE(R) Expandable VBR System

K142205 · Nuvasive, Inc. · MQP · Feb 20, 2015 · Orthopedic

Device Facts

• Record ID: K142205
• Device Name: NuVasive X-CORE(R) Expandable VBR System
• Applicant: Nuvasive, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X-CORE Expandable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Device Story

The X-CORE® Expandable VBR System is a spinal implant used to replace diseased or damaged vertebral bodies in the thoracolumbar spine. It functions as a vertebral body replacement (VBR) device, providing structural support to restore height and decompress neural tissues. The device is implanted by a surgeon during spinal surgery and must be used in conjunction with cleared supplemental internal spinal fixation systems. Autograft or allograft material may be placed within the device at the surgeon's discretion. The system is available in various shapes and sizes to accommodate patient-specific anatomy and pathology.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic axial compression, static and dynamic torsion, and expulsion testing conducted in accordance with ASTM F2077.

Technological Characteristics

Constructed from Ti-6Al-4V ELI titanium alloy conforming to ASTM F136 and ISO 5832-3. The device is an expandable vertebral body replacement implant available in various geometries. It is a mechanical implant requiring supplemental fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or fracture, to restore vertebral height and achieve decompression of spinal cord and neural tissues. Must be used with supplemental internal spinal fixation.

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

• NuVasive Expandable Lumbar Interbody System (K090176)
• NuVasive Mesh (K032476)
• Osteotech VBR (K012254)
• DePuy Surgical Titanium Mesh System (K030349)
• Synthes Spine Synex Spacer System (K003836)
• Synthes Spine Synex Spacer System (K061891)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

NuVasive, Incorporated Ms. Olga Lewis Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K142205

Trade/Device Name: NuVasive X-CORE® Expandable VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 22, 2015 Received: January 23, 2015

Dear Ms. Lewis:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Olga Lewis

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Lori A. Wiggins -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) K142205

Device Name

NuVasive X-CORE® Expandable VBR System

### Indications for Use (Describe)

The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The Nu Vasive X-CORE Expandable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in purple.

### 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### Submitted by: A.

Olga Lewis Specialist. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: January 22, 2015

#### B. Device Name

| | Trade or Proprietary Name: | <i>NuVasive X-Core® Expandable VBR System</i> |
|--|----------------------------|-----------------------------------------------|
| | Common or Usual Name: | Spinal Vertebral Body Replacement Device |
| | Classification Name: | Spinal Intervertebral Body Fixation Orthosis |

| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 888.3060 |
| Product Code: | MQP |

#### C. Predicate Devices

The subject X-Core® Expandable VBR System is substantially equivalent to the primary predicate device NuVasive Expandable Lumbar Interbody System (K090176) and additional predicate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System (K030349), and Synthes Spine Synex Spacer System (K003836 and K061891).

#### D. Device Description

The X-Core® Expandable VBR System is manufactured from Ti-6A1-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to NuVasive Expandable Lumbar Interbody System (K090176).

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#### E. Intended Use

The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X-CORE Expandable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

#### F. Technological Characteristics

As was established in this submission, the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function.

#### G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to other predicate devices. The following testing was performed:

- Static and dynamic axial compression per ASTM F2077
- Static and dynamic Torsion per ASTM F2077
- Expulsion testing

The results demonstrate that the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to predicate devices. No non-clinical studies were conducted.

#### H. Conclusions

Based on the indications for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject NuVasive X-CORE Expandable VBR System has been shown to be substantially equivalent to legally marketed predicate devices.