ZAVATION CERVICAL PLATE SYSTEM

K112533 · Zavation, LLC · KWQ · Dec 8, 2011 · Orthopedic

Device Facts

• Record ID: K112533
• Device Name: ZAVATION CERVICAL PLATE SYSTEM
• Applicant: Zavation, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Device Story

Zavation Cervical Plate System consists of titanium alloy plates and self-tapping/self-drilling screws; used for anterior cervical spine (C2-C7) stabilization as adjunct to fusion. System provides mechanical support to treat degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, or failed fusion. Implanted by surgeons in clinical/OR settings. Device provides structural stabilization to facilitate spinal fusion; benefits patient by restoring spinal alignment and stability.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F1717, including static compression bending, torsion, and dynamic compression bending on worst-case constructs. Results demonstrate performance equivalent or superior to predicate devices.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F136. System comprises plates and self-tapping/self-drilling screws. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for anterior screw fixation of cervical spine (C2-C7) as adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, deformity (kyphosis, lordosis, scoliosis), tumor, pseudarthrosis, or failed previous fusion.

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

• Window Cervical Plate System (K993066)
• Trestle Alphatec Spine (K070681)
• Slim-Loc Depuy Spine (K013877)

Submission Summary (Full Text)

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

DEC - 8 2011

# 510K Summary

| Date: | August 27, 2011 |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Submitter: | Zavation LLC<br>501 Avalon Way<br>Brandon, MS 39047<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Cervical Plate System |
| Common name: | Anterior Cervical Plate |
| Classification regulation: | 888.3060 |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | KWQ |
| Basis for submission: | New device |

#### Device Description:

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

#### Intended Use:

The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

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

#### · Materials:

The Zavation Cervical Plate System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.

## Predicate Device:

Window Cervical Plate System (K993066) Trestle Alphatec Spine (K070681) Slim-Loc Depuy Spine (K013877)

# Technological Characteristics:

The Zavation Cervical Plate System possesses the same technological characteristics as the predicate. These include: basic design (plate designed fixation system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use (as described above).

### Performance Data:

Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate device.

### Conclusion:

The Zavation Cervical Plate System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol and text are presented in black against a white background.

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

DEC - 8 2011

Zavation, LLC % Mr. John Walker 501 Avalon Way Brandon, Mississippi 39047

Re: K112533

Trade/Device Name: Zavation Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: November 02, 2011 Received: November 03, 2011

Dear Mr. Walker:

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

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

Page 2 - Mr. John Walker

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 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.

ely yours,
for

Det

m

Det U-

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K112533

Device Name: Zavation Cervical Plate System

Indications For Use:

The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous 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 CDRA _///H , Office of Device Evaluation (ODE) |
|-------------------------------------------------------------------------|
|-------------------------------------------------------------------------|

Page 1 of 1

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

KII2533 510(k) Number.