2 Hole Lateral Plating System

K172131 · Life Spine, Inc. · KWQ · Aug 28, 2017 · Orthopedic

Device Facts

• Record ID: K172131
• Device Name: 2 Hole Lateral Plating System
• Applicant: Life Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications: - Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - Spondylolisthesis - Spinal stenosis - Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion - Trauma (i.e., fracture or dislocation)

Device Story

2 Hole Lateral Plating System is a spinal fixation orthosis; provides immobilization and stabilization of thoracic and lumbar spinal segments (T1-L5) as an adjunct to fusion. System comprises titanium alloy plates and screws in various configurations/sizes. Surgeon selects appropriate implant size based on patient anatomy and pathology. Used in surgical settings to treat acute/chronic instabilities including degenerative disc disease, deformities, and trauma. Device functions as non-pedicle lateral or anterolateral fixation. Benefits include spinal stabilization to facilitate fusion.

Clinical Evidence

Bench testing only. Performance data included static compression, dynamic compression, and static torsion testing per ASTM F1717, alongside benchtop screw push-out testing.

Technological Characteristics

Constructed from titanium alloy 6AL-4V-ELI (ASTM F-136). System includes plates (16mm-26mm) and screws (5.5mm/6.5mm diameter; 25mm-60mm length). Non-pedicle lateral/anterolateral fixation design. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring spinal segment immobilization as an adjunct to fusion for thoracic and lumbar (T1-L5) instabilities including degenerative disc disease, spondylolisthesis, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, failed fusion, and trauma.

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

• Orthofix Skyhawk (K140260)
• Eminent Spine Black Diamond (K133194)
• Globus Plymouth (K120092)
• Nuvasive Lateral Plate (K091071)
• Presidio Anterior Lumbar Plate (K132589)

Submission Summary (Full Text)

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

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

Life Spine, Inc. Mr. Randy Lewis General Manager 13951 South Ouality Drive Huntley, Illinois 60142

August 28, 2017

Re: K172131

Trade/Device Name: 2 Hole Lateral Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 13, 2017 Received: July 14, 2017

Dear Mr. Lewis:

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 (reporting of medical device

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

related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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 (DICE) 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

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

## Indications for Use

510(k) Number (if known) K172131

Device Name

2 Hole Lateral Plating System

#### Indications for Use (Describe)

The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:

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

- Spondylolisthesis

-Spinal stenosis

- -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-Tumor

-Pseudoarthrosis

-Failed previous fusion

-Trauma (i.e., fracture or dislocation)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

### 510(k) Summary 2 Hole Lateral Plating System

| Submitted By: | Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 13th, 2017 |
| Trade Name: | 2 Hole Lateral Plating System |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Classification: | KWQ, 21 CFR 888.3060, Class II |
| Primary Predicate : | Orthofix Skyhawk (K140260) |
| Additional Predicate: | Eminent Spine Black Diamond (K133194)<br>Globus Plymouth (K120092)<br>Nuvasive Lateral Plate (K091071)<br>Presidio Anterior Lumbar Plate (K132589) |

#### Device Description:

The 2 Hole Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

The plates are manufactured in a variety of configurations with options including lengths of 16mm-26mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

The 2 Hole Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

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

## Intended Use of the Device:

The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:

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

- Spondylolisthesis
- -Spinal stenosis
- -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
- -Tumor
- -Pseudoarthrosis
- -Failed previous fusion
- -Trauma (i.e., fracture or dislocation)

## Technological Characteristics:

The 2 Hole Lateral Plating System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

### Performance Data:

Static compression, dynamic compression and static torsion testing according ASTM F1717, as well as benchtop screw push out testing, was presented to demonstrate the substantial equivalency of The 2 Hole Lateral Plating System.

#### Conclusions:

The 2 Hole Lateral Plating System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.