The Plateau-LO Spacer System

K172105 · Life Spine, Inc. · MAX · Feb 2, 2018 · Orthopedic

Device Facts

• Record ID: K172105
• Device Name: The Plateau-LO Spacer System
• Applicant: Life Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Feb 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Plateau-LO Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Story

Intervertebral body fusion device; used in spinal fusion procedures. Implant features hollow design for autogenous bone graft packing; superior/inferior surface teeth prevent rotation/migration. Available in various sizes/footprints to match patient anatomy. Used by surgeons in clinical settings; requires supplemental internal spinal fixation (e.g., pedicle screws). Benefits patient by promoting intervertebral fusion in DDD cases.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including engineering rationale, finite element analysis, and expulsion testing.

Technological Characteristics

Materials: PEEK (Polyetheretherketone) with tantalum markers. Design: Hollow intervertebral spacer with surface teeth for endplate interface. Single-use. Non-active device.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade 1 spondylolisthesis, who have failed at least six months of 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

• The Plateau Spacer System (K080411)
• The Plateau-X Spacer System (K151116)
• The ProLift Expandable System (K153400)
• The Globus Sustain System (K151665)
• The Medtronic CAPSTONE CONTROL System (K120368)

Submission Summary (Full Text)

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February 2, 2018

Life Spine Inc. Randy Lewis General Manager 13951 S Quality Drive Huntley, Illinois 60142

Re: K172105

Trade/Device Name: The Plateau-LO Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 22, 2018 Received: January 24, 2018

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

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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.

For comprehensive regulatory information about medical devices and radiation-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,

# Katherine D. Kavlock -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) K172105

#### Device Name The Plateau-LO Spacer System

#### Indications for Use (Describe)

The Plateau-LO Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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## K172105 Page 1 of 2

### 510(k) Summary The Plateau-LO Spacer 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 12th, 2017 |
| Trade Name: | The Plateau-LO Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, 21 CFR 888.3080, Class II |
| Primary Predicate : | The Plateau Spacer System (K080411) |
| Additional Predicate: | The Plateau-X Spacer System (K151116)<br>The ProLift Expandable System (K153400)<br>The Globus Sustain System (K151665)<br>The Medtronic CAPSTONE CONTROL System (K120368) |

### Device Description:

The Plateau-LO Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from PEEK (Polyetheretherketone) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau-LO Spacer System components with

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components from any other system or manufacturer. The Plateau-LO Spacer System components should never be reused under any circumstances.

### Intended Use of the Device:

The Plateau-LO Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

## Technological Characteristics:

The Plateau-LO Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

## Performance Data:

Engineering rationale, finite element analysis and expulsion testing was presented to demonstrate the substantial equivalency of The Plateau-LO Spacer System.

### Substantial Equivalence:

The Plateau-LO Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.