Z-Clamp ISP System

K161016 · Zavation, LLC · PEK · Oct 19, 2016 · Orthopedic

Device Facts

• Record ID: K161016
• Device Name: Z-Clamp ISP System
• Applicant: Zavation, LLC
• Product Code: PEK · Orthopedic
• Decision Date: Oct 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.

Device Story

Z-Clamp ISP System is a posterior, non-pedicle spinal fixation device; provides supplemental stabilization as an adjunct to single-level lumbar fusion (L1-S1). System consists of titanium alloy plates and lock screws; available in various sizes to accommodate patient anatomy. Implanted by surgeons during spinal fusion procedures to stabilize the spinous process. Device is non-sterile, single-use. Benefits include mechanical stabilization of the lumbar spine segment to facilitate fusion in patients with degenerative disc disease, spondylolisthesis, trauma, or tumor. Not intended for standalone use.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static torsion, static compression bending, dynamic compression bending, static foam pull-off, and static plate dissociation tests conducted according to modified ASTM F1717 on worst-case constructs.

Technological Characteristics

Spinal interlaminal fixation orthosis. Materials: Titanium alloy (Ti-6AL-4V ELI per ASTM F136). Components: Plates and lock screws. Non-sterile, single-use. Mechanical testing performed per modified ASTM F1717.

Indications for Use

Indicated for patients requiring supplemental fixation as an adjunct to single-level lumbar fusion (L1-S1) for degenerative disc disease (discogenic back pain), spondylolisthesis, trauma (fracture/dislocation), or tumor. Not for standalone use.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Spineart, Romeo 2Pad (K141508)

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

October 20, 2016

Zavation, LLC Mr. Milton Phillips Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K161016

Trade/Device Name: Z-Clamp ISP System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 20, 2016 Received: September 21, 2016

Dear Mr. Phillips:

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" (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,

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) K161016

Device Name Z-Clamp ISP System

#### Indications for Use (Describe)

The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510K Summary

| Date: | September 20, 2016 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation, LLC<br>220 Lakeland Parkway<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | Milton Phillips |
| Trade name: | Z-CLAMP ISP System |
| Classification: | Spinal Interlaminal Fixation Orthosis<br>21 CFR 888.3050<br>Product Code: PEK<br>Regulatory Class: II<br>Panel Code: 87 |
| Primary Predicate: | |

K141508 Spineart, Romeo 2Pad

# Device Description:

The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of nonsterile, single use implantable components. The system consist of plates and lock screw. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

# Indications for Use:

The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction to fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation) and /or tumor. The Z-Clamp ISP System is not intended for standalone use.

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K161016 Page 2 of 2

## Technological Characteristics:

The Z-CLAMP ISP System possesses the same technological characteristics, design and principles of operation as the predicates. These include: basic design, material, intended use and indications.

## Performance Data:

Static torsion test, static compression bending test, dynamic compression bending test, static foam pull-off test and static plate dissociation test were performed according to a modified ASTM F1717 on a worst-case construct. The mechanical test results demonstrated the Z-CLAMP ISP System performs as well as or better than the predicate devices.

## Conclusion:

The Z-CLAMP ISP System is substantially equivalent to the predicate device referenced above.