Z-LINK CERVICAL

K141005 · Zavation, LLC · OVE · Aug 7, 2014 · Orthopedic

Device Facts

• Record ID: K141005
• Device Name: Z-LINK CERVICAL
• Applicant: Zavation, LLC
• Product Code: OVE · Orthopedic
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.

Device Story

Z-Link Cervical is a stand-alone anterior cervical interbody fusion device; consists of PEEK spacer, titanium interbody plate, and bone screws. Implanted via anterior approach; spacer packed with autogenous bone graft to facilitate fusion. Spacer features serrated endplate surfaces; plate includes screw locks for bone screws. Used by surgeons in clinical settings to treat degenerative disc disease. Device provides mechanical stabilization of the cervical spine segment; promotes fusion through bone graft containment. Benefits include reduction of radicular symptoms and stabilization of the affected vertebral level.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static/dynamic axial compression, static/dynamic torsion), ASTM F2267 (subsidence), and ASTM Draft F04.25.02.02 (static pushout).

Technological Characteristics

Spacer: PEEK (ASTM F2026) with Tantalum marker (ASTM F560). Plate/Screws: Titanium alloy (ASTM F136). Stand-alone interbody fusion device with integrated screw locking mechanism. Mechanical fixation via bone screws.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one level from C2-T1, confirmed by history and radiography, following six weeks 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

• LDR Spine Cervical Interbody Fusion System (K091088)
• Zavation IBF System (K120576)
• Synthes Zero-P VA (K121852)
• SpineSmith IN:C2 Spinal Fixation System (K122630)
• Globus Coalition Spacer (K131449)

Submission Summary (Full Text)

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

August 7, 2014

Zavation, LLC Mr. John Walker Engineering Manager 400 Liberty Park Drive Flowood, Mississippi 39232

K141005 Re: Trade/Device Name: Zavation Z-Link Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: July 22, 2014 Received: July 24, 2014

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, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education at its toll-free 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" (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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Ronald & Nean -S 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) K141005

Device Name Zavation Z-Link Cervical

#### Indications for Use (Describe)

The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Anton E. Dmitriev, PhD

# Division of Orthopedic Devices

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# 510K Summary

| Date: | August 4, 2014 |
|----------------------------|---------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation LLC<br>400 Liberty Park Drive<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Z-Link Cervical |
| Common name: | Intervertebral Body Fusion Device |
| Classification regulation: | 21 CFR 888.3080 Intervertebral body fusion device |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | OVE |
| Basis for submission: | New device |

### Device Description:

The Zavation Z-Link Cervical includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

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### Intended Use:

The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.

# Materials:

The spacer component is manufactured from medical grade PEEK Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136).

## Predicate Devices:

LDR Spine Cervical Interbody Fusion System (K091088) Zavation IBF System (K120576) Synthes Zero-P VA (K121852) SpineSmith IN:C2 Spinal Fixation System (K122630) Globus Coalition Spacer (K131449)

## Performance Data:

Mechanical test results demonstrated that the Zavation Z-Link Cervical is substantially equivalent to the predicate devices. Testing was performed in accordance with:

- · ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- o Static Axial Compression
- Dynamic Axial Compression o
- Static Torsion o
- o Dynamic Torsion
- . ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- . ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.