Virtu C Spinal Implant System

K161649 · Met 1 Technologies, LLC · ODP · Nov 9, 2016 · Orthopedic

Device Facts

• Record ID: K161649
• Device Name: Virtu C Spinal Implant System
• Applicant: Met 1 Technologies, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Nov 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an Intervertebral Body Fusion Device: The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment. When used as a Vertebral Body Replacement Device: The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

Device Story

Virtu C Spinal Implant System consists of intervertebral body fusion and vertebral body replacement implants. Implants are placed into the spinal column to provide stability, support fusion, or restore vertebral height following decompression. Used in surgical settings by orthopedic or neurosurgeons. Implants are used in conjunction with autograft/allograft bone and FDA-cleared supplemental fixation systems (e.g., pedicle screws). Benefits include spinal stabilization and restoration of anatomical height in degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Performance data includes static and dynamic axial compression (ASTM F2077), static and dynamic torsion (ASTM F2077), static subsidence (ASTM F2267), and static expulsion (ASTM F-04.25.02.02).

Technological Characteristics

Implants manufactured from VESTAKEEP® i4 R PEEK (ASTM F2026) with tantalum markers (ASTM F560). Device is a passive mechanical implant provided in various sizes to accommodate patient anatomy. No energy source or software components.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (C2-T1) requiring fusion with bone graft and supplemental fixation, or patients with thoracolumbar (T1-L5) vertebral body damage/instability due to trauma, fracture, or tumor requiring replacement, decompression, and supplemental fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Calix™ Spinal Implant System (K112036)

Reference Devices

• Calix™ Spinal Implant System (K083637)
• X-CORE® Expandable VBR System (K142205)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human figure in profile, with three overlapping faces.

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

November 9, 2016

Met 1 Technologies, LLC % Mr. Kenneth C. Maxwell Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K161649

Trade/Device Name: Virtu C Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: October 3, 2016 Received: October 6, 2016

Dear Mr. Maxwell:

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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.

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,

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K161649 Device Name

Virtu C Spinal Implant

Indications for Use (Describe)

#### When used as an Intervertebral Body Fusion Device:

The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

When used as a Vertebral Body Replacement Device:

The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

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

区 Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

PSC Publishing Services [phone] EB

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510(K) SUMMARY

| Submitter's Name: | Met 1 Technologies, LLC |
|----------------------------|----------------------------------------------------------------------------------------------------|
| Submitter's Address: | 154 N. Festival Dr., Ste. F<br>El Paso, TX 79912 |
| Submitter's Telephone: | 915.301.0834 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.337.7579 |
| Date Summary was Prepared: | 09 November 2016 |
| Trade or Proprietary Name: | Virtu C Spinal Implant |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical<br>Spinal Vertebral Body Replacement System |
| Classification: | Class II per 21 CFR §888.3080<br>Class II per 21 CFR §888.3060 |
| Product Code: | ODP, MQP |
| Classification Panel: | Division of Orthopedic Devices |

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Met 1 Technologies Virtu C Spinal Intervertebral Body Fusion Device is a cervical intervertebral body fusion device that is implanted into the invertebral body space to improve stability of the spine while supporting fusion. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

The Met 1 Technologies Virtu C Spinal Vertebral Body Replacement Device is a thoracolumbar vertebral body replacement device that is implanted to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

#### INDICATIONS FOR USE

When used as an Intervertebral Body Fusion Device:

The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

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# When used as a Vertebral Body Replacement Device:

The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or turnor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

# TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:

- . Indications for Use
- Materials of manufacture ●
- Principle of operations

#### Table 5-1: Predicate Devices

| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Predicate<br>Type |
|----------------|------------------------------------|-----------------|-------------------|
| K112036 | Calix™ Spinal Implant System | X-Spine Systems | Primary |
| K083637 | Calix™ Spinal Implant System | X-Spine Systems | Reference |
| K142205 | X-CORE® Expandable VBR System | NuVasive | Reference |

### PERFORMANCE DATA

The Virtu C Spinal Implant System has been tested in the following test modes and demonstrated substantial equivalence:

- Static axial compression per ASTM F2077
- Static torsion per ASTM F2077
- . Static subsidence per ASTM F2267
- Static expulsion per ASTM F-04.25.02.02 ●
- Dynamic axial compression per ASTM F2077 ●
- . Dynamic torsion per ASTM F2077

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Virtu C Spinal Implant System is substantially equivalent to the predicate device.