Rampart A Lumbar Interbody Fusion Device

K153082 · Spineology, Inc. · MAX · Feb 4, 2016 · Orthopedic

Device Facts

• Record ID: K153082
• Device Name: Rampart A Lumbar Interbody Fusion Device
• Applicant: Spineology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Feb 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Story

Rampart A is an intervertebral body fusion device designed for anterior or anterolateral placement in the lumbar disc space. It consists of a hollow-core implant used to stabilize spinal segments by holding autogenous bone graft to facilitate fusion. The device is implanted by a surgeon using specialized insertion instruments. It is intended to be used in conjunction with FDA-cleared supplemental fixation systems. The device provides structural support to the intervertebral space, promoting bone growth and spinal stabilization. It is used in a clinical/surgical setting.

Clinical Evidence

No clinical data provided. Substantial equivalence was supported by engineering rationale and finite element analysis (FEA) comparing the device to existing predicate testing conducted in accordance with ASTM F2077.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 with Tantalum markers. Form factor: Hollow-core implant in various configurations and heights. Principle: Intervertebral body fusion device for stabilization. Testing: ASTM F2077 (via FEA comparison).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one or two contiguous lumbar levels (L2-S1) who have failed 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

• Spineology PEEK Lumbar Interbody Fusion Device (K123652)
• Rampart O, Rampart T Lumbar Interbody Fusion Device (K132053)
• Spineology PEEK Lumbar Interbody Fusion Device (K121129)

Reference Devices

• SynFix-LR (K072253)

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

February 4, 2016

Spineology, Incorporated Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 St. Paul, Minnesota 55128

Re: K153082

Trade/Device Name: Rampart A Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 22, 2015 Received: October 23, 2015

Dear Ms. Hauge:

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) K153082

#### Device Name

Rampart A Lumbar Interbody Fusion Device

#### Indications for Use (Describe)

Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment.

Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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

| <span style="text-align:left">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-align:left">☑</span> |
|-----------------------------------------------------------------------------------|----------------------------------------|
| <span style="text-align:left">Over-The-Counter Use (21 CFR 801 Subpart C)</span> | <span style="text-align:left">☐</span> |

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Image /page/3/Picture/0 description: The image shows the text "510(k) Summary". The text is in a large, bold font and is centered on the page. The text is likely the title of a document or section of a document.

Image /page/3/Picture/1 description: The image shows the logo for Spineology. The word "Spineology" is written in a bold, sans-serif font. Below the word "Spineology" is the phrase "anatomy conserving surgery" in a smaller font. To the right of the word "Spineology" is a pink graphic of a cluster of circles.

Date Prepared:

| Applicant: | Spineology, Inc.<br>7800 3rd Street N.<br>Suite 600<br>Saint Paul, MN 55128 |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | Establishment Registration Number: 2135156 |
| Contact Person: | Jacqueline A. Hauge<br>Regulatory Affairs Manager |
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name and Classification | |
| Trade Name:<br>Regulation Name:<br>Regulation Number:<br>Product Code:<br>Regulatory Class:<br>510(k) Review Panel: | Rampart A Lumbar Interbody Fusion Device<br>Intervertebral body fusion device<br>21 CFR 888.3080<br>MAX<br>Class II<br>Orthopedic |
| Predicate Devices | |
| Primary Predicate<br>K123652 | Spineology PEEK Lumbar Interbody Fusion Device |
| Additional Predicates | |

October 22, 2015

Rampart O, Rampart T Lumbar Interbody Fusion Device K132053 Spineology PEEK Lumbar Interbody Fusion Device K121129

### Reference Device

K072253 SynFix-LR (Synthes Spine)

## Purpose of Submission

The purpose of this submission is to introduce the Rampart A Lumbar Interbody Fusion Device, a modified version of Spineology's previously cleared interbody fusion devices designed to accommodate anatomical features conducive to anterior or anterolateral placement within the intervertebral disc space.

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Image /page/4/Picture/0 description: The image shows the logo for Spineology. The logo consists of the word "Spineology" in a bold, sans-serif font. Below the word "Spineology" is the phrase "anatomy conserving surgery" in a smaller, lighter font. To the right of the word "Spineology" is a graphic of a cluster of pink dots.

# Device Description

Rampart A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

# Indications for Use

Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

# Comparison to Predicate

When compared to the predicate devices, Rampart A has the same:

- · Intended Use
- · Technological Characteristics · · · Method of Sterilization
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- · Materials of Construction

# Summary of Performance and Biological Testing

No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device.

Because the materials of construction remain unchanged from the predicate devices, the existing biological data remain valid and no new biocompatibility testing was required for this change.

# Conclusion

Spineology has demonstrated that Rampart A devices are substantially equivalent to the predicate devices. The fundamental scientific principle, technological characteristics, and intended use are unchanged from the predicate devices.

- · · · · · · · · · Packaging Materials
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- Operating Principle
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