Zavation Cervical Plate System

K181244 · Zavation Medical Products, LLC · KWQ · Jul 10, 2018 · Orthopedic

Device Facts

• Record ID: K181244
• Device Name: Zavation Cervical Plate System
• Applicant: Zavation Medical Products, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 10, 2018
• 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 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 stabilization (C2-C7) as adjunct to fusion. Device provides mechanical fixation to treat degenerative disc disease, trauma, deformity, and other spinal pathologies. System is intended for use by surgeons in clinical/OR settings. Submission specifically covers addition of sterile packaging options for existing implants and instruments. No new biomechanical testing performed; substantial equivalence based on identical design, materials, and intended use to predicate systems.

Clinical Evidence

No clinical data. Bench testing was not repeated as the submission is limited to the addition of sterile packaging options for the predicate device.

Technological Characteristics

Implants manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136. System includes plates and self-tapping/self-drilling screws in various dimensions. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for anterior screw fixation of the cervical spine (C2-C7) as an 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

• Zavation Cervical Plate System (K112533)
• SKYLINE Anterior Cervical Plate System (K103491)

Submission Summary (Full Text)

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Zavation Medical Products LLC Mr. Matt Jones Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K181244

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: KWQ Dated: May 4, 2018 Received: May 10, 2018

Dear Mr. Jones:

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 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);

July 10, 2018

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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for 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) K181244

Device Name Zavation Cervical Plate System

#### Indications for Use (Describe)

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 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K181244 - 510K Summary

| Date: | May 4, 2018 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation Medical Products LLC<br>220 Lakeland Pkwy<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Matt Jones |
| 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: | Addition of sterile packaged implants and instruments. |
| Prior Submissions: | K112533 and K130030. Both received Substantial<br>Equivalence determinations |

#### 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.

#### Materials:

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

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## Primary Predicate Device:

K112533 Zavation Cervical Plate System [Zavation]

#### Additional Predicate Device:

K103491 SKYLINE Anterior Cervical Plate System [DePuy]

## Technological Characteristics:

The Zavation Cervical Plate System possesses the same technological characteristics as the predicates. 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:

Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device.

### Conclusion:

The Zavation Cervical Plate System is substantially equivalent to the devices referenced above.