Z-Span Plate System

K160362 · Zavation, LLC · KWQ · Mar 22, 2016 · Orthopedic

Device Facts

• Record ID: K160362
• Device Name: Z-Span Plate System
• Applicant: Zavation, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1). The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in skeletally mature patients in the treatment of the following: - Fracture (including dislocation and subluxation) - Tumor - Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - Pseudoarthrosis - Spondylolysis - Spondylolisthesis - Scoliosis - Lordotic deformities of the spine - Spinal stenosis - Failed previous spine surgery

Device Story

Z-Span Plate System is a supplemental spinal fixation device comprising titanium alloy plates and screws. Used by surgeons in clinical settings to provide immobilization and stabilization as an adjunct to spinal fusion. Device components are implanted via lateral, anterolateral, or anterior surgical approaches to the lumbar and lumbosacral spine. By securing the vertebral bodies, the system stabilizes the spinal segment, facilitating fusion and potentially reducing pain and deformity associated with spinal pathologies. The device is purely mechanical; no software or electronic components are involved.

Clinical Evidence

Bench testing only. Mechanical performance was evaluated via static and dynamic axial compression, bending, and torsion testing in accordance with ASTM F1717. Results demonstrate performance comparable to or better than predicate devices.

Technological Characteristics

Spinal intervertebral body fixation orthosis. Materials: Titanium alloy (Ti-6AL-4V ELi) per ASTM F-136. Design: One-level lumbar and sacral plates and screws. Mechanical fixation principle. No energy source, software, or connectivity.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization as an adjunct to fusion for fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities, spinal stenosis, or failed previous surgery in the lumbar (L1-L5) or lumbosacral (L1-S1) spine.

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

• Synthes, Antegra System (K063158)
• Orthofix, Skyhawk Plate System (K140260)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

March 22, 2016

Zavation, LLC Mr. Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K160362

Trade/Device Name: Z-Span Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 8, 2016 Received: February 9, 2016

Dear Mr. Cummins:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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 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,

# 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) K160362

Device Name Z-Span Plate System

#### Indications for Use (Describe)

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

- · Fracture (including dislocation and subluxation)
- Tumor

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

- · Pseudoarthrosis
- · Spondylolysis
- · Spondylolisthesis
- · Scoliosis
- · Lordotic deformities of the spine
- · Spinal stenosis
- · Failed previous spine surgery

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

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

|X Prescription Use (Part 21 CFR Subbart Di ounter Use (21 CFR 801 Suppart C)

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# 510K Summary

| Date: | Feb 08, 2016 |
|---------------------------------|--------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation, LLC<br>220 Lakeland Parkway<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | Frankie Cummins |
| Type of 510(k) submission: | Traditional |
| Trade name: | Z-Span Plate System |
| Common Name: | Spinal Fixation System |
| Classification regulation/code: | 888.3060, KWQ |
| Classification name: | Spinal Intervertebral Body Fixation Orthosis |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Basis for submission: | New device |

#### Device Description:

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)

#### Indications for Use:

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

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The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

- Fracture (including dislocation and subluxation) ●
- . Tumor
- Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Scoliosis
- Lordotic deformities of the spine
- Spinal stenosis ●
- . Failed previous spine surgery

#### Predicate Device:

Primary: Synthes, Antegra System (K063158) Additional: Orthofix, Skyhawk Plate System (K140260)

### Technological Characteristics:

The technological characteristics including material, design and performance of the Z-Span Plate System are consistent with those of the predicate devices.

## Performance Data:

Mechanical testing of the Z-Span Plate System consisting of static and dynamic axial compression bending testing and static torsion testing was conducted in accordance with ASTM F1717. Test results demonstrate that the Z-Span Plate System performs as well as or better than the predicate device and is therefore substantially equivalent to the predicate devices.

## Conclusion:

Based on the similarities in materials, design, principles of function, intended use and indications, the Z-Span Plate system has been shown to be substantially equivalent to the predicate devices. Non-clinical data demonstrates the Z-Span Plate System is as safe, as effective, and performs as well as the predicate devices. The Z-Span Plate System does not raise new safety and effectiveness questions.