VARILIFT-L INTERBODY FUSION DEVICE

K131296 · Wenzel Spine, Inc. · MAX · Sep 3, 2013 · Orthopedic

Device Facts

• Record ID: K131296
• Device Name: VARILIFT-L INTERBODY FUSION DEVICE
• Applicant: Wenzel Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

Device Story

VariLift-L/A are self-tapping, expandable interbody fusion devices; titanium alloy construction; feature interior sliding wedge, posterior end cap, and fenestrations for autograft. Implanted by surgeons via posterior (PLIF), transverse (TLIF), or anterior (ALIF) lumbar approaches. Designed to facilitate spinal fusion in DDD patients. Modifications include improved orientation features to prevent loading errors and updated instrumentation threadforms. Used with or without supplemental fixation. Benefits include stabilization of spinal segments and promotion of bony fusion.

Clinical Evidence

Bench testing only. Static compression, shear, torsion, and dynamic axial testing performed per ASTM F2077 demonstrated mechanical equivalence to predicate.

Technological Characteristics

Self-tapping, expandable interbody fusion device; titanium alloy (ASTM F136); features interior sliding wedge, posterior end cap, and fenestrations for autograft; dimensions/threadforms modified for instrumentation compatibility.

Indications for Use

Indicated for intervertebral body fusion of lumbar spine (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis, following 6 months of failed non-operative treatment.

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 Interbody Fusion System (K100820)
• BAK Cage (P950002)
• Ray Threaded Fusion Cage (P950019)
• Lumbar I/F Cage (P960025)
• Perimeter Interbody Fusion Device (K111525, K090353)

Submission Summary (Full Text)

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| 510(k) Summary | | |
|-------------------------------|--------------------------------------------------------------------------------|--|
| Company Name: | Wenzel Spine, Inc. | |
| | 206 Wild Basin Road, Building A, Suite 203 | |
| | Austin, TX 78746 | |
| Contact Name: | Sandie Roth | |
| | Director of Clinical Affairs | |
| | Phone: [phone] | |
| | Fax: [phone] | |
| Date Special 510(k) Prepared: | May 1, 2013 | |
| Trade Name: | VariLift-L® Interbody Fusion Device | |
| Common Name: | Intervertebral Body Fusion Device | |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar (21<br>CFR 888.8030) | |
| Product Code: | MAX | |

## Description of Device:

The Wenzel Spine VariLift Interbody Fusion System is offered in two (2) configurations of various sizes that are designed based on surgical approach, and consist of:

- 1) VariLift-L®, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
- 2) VariLift-A®, which may be implanted bi-laterally via an anterior (ALIF) approach.

A design change was made on all sizes of the VariLift-L® devices to eliminate the risk of orientation error when loading the implant on the insertion instruments. Additionally, dimensional and threadform modifications were made to the instrumentation to ensure all instruments work with the modified devices.

### Indications for Use:

The Wenzel Spine VariLift Interbody Fusion System (VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

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VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

### Technical Characteristics:

The VariLift-L® and VariLift-A® are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. They are grooved and fluted devices with large fenestrations (graft windows) positioned between each of the four quadrants that provide bony contact with the endplates. The devices are made of titanium alloy (per ASTM F136).

#### Legally Marketed Predicate Devices and Substantial Equivalence:

The subject VariLift-L® Interbody Fusion Device is substantially equivalent to the predicate VariLift Interbody Fusion System (K100820, August 5, 2010) in terms of technology, design, and intended use. Additional predicate devices include down-classified cages and other cleared interbody fusion devices such as BAK Cage (P950002), Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and Perimeter Interbody Fusion Device (K111525, K090353).

# Summary of Non-Clinical Performance Testing:

Design Modifications to Existing Sizes: Non-clinical testing was conducted to determine substantial equivalence to the original VariLift-L® design. Static compression, shear and torsion testing and dynamic axial testing (per ASTM 2077: "Test methods for Intervertebral Body Fusion Devices") demonstrated that the subject and predicate VariLift-L® Interbody Fusion devices are substantially equivalent in terms of mechanical performance.

Design Modification to Instrumentation: Minor modifications to the VariLift-L® instrumentation were made. An engineering analysis was performed to confirm substantial equivalence to previously cleared instrumentation.

#### Conclusion:

The subject VariLift-L® Interbody Fusion Device is substantially equivalent to the predicate VariLift-L® Interbody Fusion Device (K100820) in terms of fundamental technology, intended use, indications for use and intervertebral body design and fundamental scientific technology.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 3, 2013

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

Wenzel Spine, Incorporated % Ms. Sandie Roth Director of Clinical Affairs 206 Wild Basin Road, Building A, Suite 203 Austin, Texas 78746

Re: K131296

Trade/Device Name: VariLift Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 20, 2013 Received: August 22, 2013

Dear Ms. Roth:

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. Sandie Roth

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 -S

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): K131296

Device Name: VariLift Interbody Fusion System

Indications For Use:

. "

The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of decenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bl-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

Prescription Use × (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 IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Caroline Rhim -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131296