VARILIFT -C

K120603 · Wenzel Spine · ODP · Jan 29, 2013 · Orthopedic

Device Facts

• Record ID: K120603
• Device Name: VARILIFT -C
• Applicant: Wenzel Spine
• Product Code: ODP · Orthopedic
• Decision Date: Jan 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Device Story

VariLift-C is a self-tapping, expandable interbody fusion device with an internal sliding wedge; cylindrical-ovoid shape; composed of Titanium-6Al-4V ELI alloy. Device features grooves, flutes, and large fenestrations for bony contact with vertebral endplates. Used by surgeons in an anterior approach to the cervical spine to provide mechanical stability and facilitate intervertebral body fusion. Implanted unilaterally at C3-C7 levels using autograft bone; may be used with or without supplemental fixation. Provides structural support to the disc space to promote biological fusion, potentially alleviating radicular symptoms associated with degenerative disc disease.

Clinical Evidence

No new clinical data submitted. Substantial equivalence based on design, material, and intended use similarities to predicate devices.

Technological Characteristics

Material: Titanium-6Al-4V ELI alloy (ASTM F136). Form factor: Cylindrical-ovoid, expandable with internal sliding wedge. Features: Grooved, fluted, large fenestrations for graft windows. Sterilization: Supplied sterile.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C3-C7). Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 weeks of prior non-operative treatment. Contraindicated in patients without skeletal maturity or those not meeting DDD criteria.

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

• VariLift Cervical Interbody Fusion System (K111123)
• BAK/C Interbody Fusion Device (P980048)

Submission Summary (Full Text)

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# 510(k) SUMMARY Wenzel Spine's VariLift-C

| Date: | February 10, 2012 | | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Wenzel Spine, LLC<br>Sourabh Mishra<br>JAN 2 9 2013<br>Chief Technical Officer<br>206 Wild Basin Road<br>Building A, Suite 203<br>512-501-4017<br>Austin, TX 78746 | | |
| Trade Name:<br>Common Name:<br>Product Class:<br>Classification: | VariLift® Cervical Interbody Fusion Device<br>Intervertebral body fusion device<br>Class II<br>21 CFR §888.3080 Orthosis, intervertebral body fusion device | | |
| Product Code:<br>Panel Code: | ODP<br>87 | | |
| Name of Device and Name/Address of Sponsor | | | |

Wenzel Spine, LLC

206 Wild Basin Road Building A, Suite 203 Austin, TX 78746 512-501-4017

#### Device Description

The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6Al-4V ELI alloy that conforms to ASTM F136.

The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.

The device is supplied in an appropriately labeled sterile packaging.

The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

#### Predicate Devices

The VariLift-C was shown to be substantially equivalent to legally marketed predicate device. The predicate devices are the VariLift Cervical Interbody Fusion System (K11123) and the BAK/C Interbody Fusion Device (P980048).

## SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The VariLift Cervical Interbody Fusion System is substantially equivalent to the VariLift-C device previously cleared and the BAK®/C Vista Cage in terms of intended use, design, and materials used. The table below compares the features and characteristics of the VariLift Cervical Interbody Fusion System to these predicate devices.

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# K120603

| Items | VariLift Cervical<br>Interbody Fusion<br>System | VariLift Cervical<br>Interbody Fusion<br>System | BAK®/C-Vista Interbody<br>Fusion System |
|-----------------------|-------------------------------------------------|-------------------------------------------------|------------------------------------------|
| Sponsor | Wenzel Spine | Wenzel Spine | Zimmer |
| 510(K) Number | N/A | K111123 | P980048 S003 |
| Indications for Use | Per FDA Guidance | Per FDA Guidance | Per FDA Guidance |
| Material | Ti-6Al-4V alloy per<br>ASTM F136 | Ti-6Al-4V alloy per<br>ASTM F136 | PEEK Optima LT1 |
| Implant Levels | One Level | One Level | One Level |
| # Implants per level | Single or Pairs | Single or Pairs | Single or Pairs |
| Supplemental Fixation | With or Without<br>Supplemental Fixation | With Supplemental<br>Fixation | With or Without<br>Supplemental Fixation |

#### Intended Use / Indications for Use

The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.

The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

# Performance Data

Whereas the only change submitted for this Premarket Notification is a change in the Indications for Use, no new performance data is being submitted.

#### Summary:

The VariLift-C Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the cervical disc space to facilitate biologic fusion. The indications for use of the VariLift-C Interbody Fusion Device are exactly the same as one of the predicate devices. Moreover, the device is very similar in its size to the predicate device. The materials used are also the same as in the predicate device. There are no significant differences in technological characteristics compared to the predicate devices, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, clinical data presented demonstrates that these differences do not adversely impact device performance, as discussed below.

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

January 29, 2013

Wenzel Spine, LLC % Mr. Sourabh Mishra Chief Technical Officer 206 Wild Basin Road Building A. Suite 203 Austin, Texas 78746

Re: K120603

Trade/Device Name: VariLift-C® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 8, 2013 Received: January 11, 2013

Dear Mr. Mishra:

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 – Mr. Sourabh Mishra

forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson

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 Statement

510(k) Number (if known): K120603
Device Name: VariLift-C

Indications for Use:

The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.

The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Stephanie; Bechtold -S 2013.01.29 15:43:40 -05'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K120603

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