VARILIFT CERVICAL INTERBODY FUSION SYSTEM

K111123 · Wenzel Spine · ODP · Dec 8, 2011 · Orthopedic

Device Facts

• Record ID: K111123
• Device Name: VARILIFT CERVICAL INTERBODY FUSION SYSTEM
• Applicant: Wenzel Spine
• Product Code: ODP · Orthopedic
• Decision Date: Dec 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for 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(s). 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 or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with 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 Cervical Interbody Fusion System is a self-tapping, expandable, cylindrical-ovoid interbody fusion device featuring an interior sliding wedge. Constructed from Titanium-6Al-4V ELI alloy, the device is grooved and fluted with large fenestrations to facilitate bony contact with vertebral endplates. It is implanted via an anterior approach in a unilateral or bilateral fashion at C3-C7 levels to facilitate fusion. The device is intended for use in conjunction with autograft bone and supplemental fixation in skeletally mature patients with degenerative disc disease. It is used by surgeons in a clinical/surgical setting to stabilize the spine and promote fusion, potentially reducing radicular symptoms associated with disc degeneration.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression, shear, and torsion testing per ASTM F2077-03, and expulsion testing per ASTM Draft Standard F-04.25.02.02.

Technological Characteristics

Material: Titanium-6Al-4V ELI alloy (ASTM F136). Design: Cylindrical-ovoid, self-tapping, expandable with interior sliding wedge. Features: Grooved, fluted, large fenestrations for bony contact. Connectivity: None (mechanical implant). 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. Must be used with autograft 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

• BAK®/C Vista Cage (P980048 S003)
• BAK®/Cervical Interbody Fusion (P980048)
• LDR Interbody Fusion System (K091088)

Submission Summary (Full Text)

{0}------------------------------------------------

, 111123

# Wenzel Spine VariLift Cervical Interbody Fusion System

#### 510(k) Summary of Safety and Effectiveness

| SUBMITTED BY | Wenzel Spine |
|--------------|-----------------------|
| | 206 Wild Basin Rd |
| | Building A, Suite 203 |
| | Austin, TX 78746 |

| ESTABLISHMENT | 3008009850 |
|---------------------|------------|
| REGISTRATION NUMBER | |

CONTACT PERSON Sourabh Mishra Chief Technology Officer Phone: [phone] Fax: [phone]

- SUBMISSION PREPARED BY J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 [e-mail] Phone: [phone] Fax: [phone]
- April 12, 2011 DATE PREPARED

CLASSIFICATION NAME ODP 888.3080 - Intervertebral Fusion Device with Bone Graft, Cervical

Intervertebral Body Fusion Device COMMON NAME

VariLift Interbody Fusion System (VariLift-C) PROPRIETARY NAME

#### IDENTIFICATION OF PREDICATES

BAK®/C Vista Cage (P980048 S003) BAK®/Cervical Interbody Fusion (P980048) LDR Interbody Fusion System (K091088)

#### 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-6AI-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.

{1}------------------------------------------------

KIIII 23

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.

#### SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The VariLift Cervical Interbody Fusion System is substantially equivalent to 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.

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

#### INDICATIONS:

The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for 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 or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

#### DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

- Static and dynamic compression testing, conducted in accordance with l ASTM F2077-03
- Static shear testing, conducted in accordance with ASTM F2077-03 "
- Static and dynamic torsion testing, conducted in accordance with ASTM -F2077-03
- Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02

{2}------------------------------------------------

KIII23

#### CONCLUSIONS

The subject and predicate devices share the same intended use, implant design and material of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The nonclinical and clinical test results demonstrate that the VariLift Cervical Interbody Fusion System is substantially equivalent to the predicate devices and support the use of VariLift-C with supplemental fixation.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is black and appears to be part of a larger document or logo. To the left of the text is a graphic of three diagonal lines.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

DEC - 8 2011

Wenzel Spine % The OrthoMedix Group, Inc. Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K111123

Trade/Device Name: Wenzel Spine VariLift Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 9, 2011 Received: November 14, 2011

Dear Mr. Webb:

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. Iisting 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

{4}------------------------------------------------

### Page 2 - Mr. J. D. Webb

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/CDRHOffices/ucm115809.html 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,

Fer. Piffner
Dec. 66.

Mark N. Melkerso Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K 111 123

## INDICATIONS FOR USE

510(k) Number (if known):

Wenzel Spine VariLift Cervical Interbody Fusion System Device Name:

Indications for Use:

The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for 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(s).

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 or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIIII23 510(k) Number_

2720 Bee Cave Road Austin, Texas 78746 Wenzel Spine

Phone: [phone] Fax: [phone]

.1061