Rampart™ One Lumbar Interbody Fusion System

K192047 · Spineology, Inc. · OVD · Aug 23, 2019 · Orthopedic

Device Facts

• Record ID: K192047
• Device Name: Rampart™ One Lumbar Interbody Fusion System
• Applicant: Spineology, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Aug 23, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The standard and oblique Rampart One devices are integrated intervertebral body fusion devices 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 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 non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine. The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

Device Story

Rampart One Lumbar Interbody Fusion System is a line extension of intervertebral body fusion implants; provides increased lordotic angles (16°, 20°) to accommodate patient anatomy. Device consists of PEEK-OPTIMA HA Enhanced spacer, titanium alloy face plate, and tantalum radiopaque markers; incorporates integrated titanium alloy screw fixation. Used in lumbar spine (L2-S1) to stabilize spinal segments as adjunct to fusion; filled with autograft/allograft bone graft. Implanted by surgeons in clinical setting using specialized insertion instruments; screws inserted through anterior face plate into adjacent vertebral bodies. Provides mechanical stabilization of disc space; facilitates spinal fusion; benefits patients by addressing degenerative disc disease and spondylolisthesis.

Clinical Evidence

Bench testing only. Mechanical ASTM testing and risk assessment confirmed that design modifications (increased lordosis) do not alter the device's performance, safety, or effectiveness compared to the predicate.

Technological Characteristics

Materials: PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), tantalum (markers). Integrated fixation via titanium alloy screws. Various heights and lordotic angles (8°, 12°, 16°, 20°). Hollow core for bone graft. Mechanical stabilization principle. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1). DDD defined as discogenic back pain with radiographic degeneration, unresponsive to 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

• Rampart One Lumbar Interbody Fusion Device (K191091)
• NuVasive Brigade Hyperlordotic System (K123045)

Submission Summary (Full Text)

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August 23, 2019

Spineology, Inc. Andrew Adams Director of Regulatory Affairs 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K192047

Trade/Device Name: Rampart One Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 29, 2019 Received: July 31, 2019

Dear Andrew Adams:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Melissa Hall, M.S. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

# K192047

### Device Name

Rampart™ One Lumbar Interbody Fusion System

# Indications for Use (Describe)

The standard and oblique Rampart One devices are integrated intervertebral body fusion devices 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 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 non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fration, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Spineology :

# 510(k) Summary

| Date Prepared: | July 29, 2019 |
|------------------------------------|-------------------------------------------------------------------------------|
| Submitter: | Spineology Inc.<br>7800 3rd Street North<br>Suite 600<br>Saint Paul, MN 55128 |
| Establishment Registration Number: | 2135156 |
| Contact Person: | Andrew Adams<br>Director of Regulatory Affairs |
| Phone: | 651.256.8534 |
| Fax: | 651.256.8505 |
| Email: | <a href="mailto:[e-mail]">[e-mail]</a> |

Device Name and Classification

| Trade Name: | Rampart™ One Lumbar Interbody Fusion System |
|----------------------|-------------------------------------------------------|
| Common Name: | Intervertebral fusion device with integrated fixation |
| Classification Name: | OVD |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Panel: | Orthopedic |

Predicate Devices

| Primary: | K191091 Rampart™ One Lumbar Interbody Fusion Device (Spineology Inc.) |
|-------------|-----------------------------------------------------------------------|
| Additional: | K123045 NuVasive® Brigade® Hyperlordotic System (NuVasive, Inc) |

#### A. Purpose of Premarket Notification

The purpose of this premarket notification is to obtain FDA clearance for a line extension of Implants with increased lordosis to the Rampart™ One Lumbar Interbody Fusion System. The subject Implants provide additional lordosis to accommodate individual pathology and anatomical conditions. This submission also includes Class II surgical instruments unique to the implantation of the device.

### Device Description B.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of

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cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

### C. Indications for Use

The standard and oblique Rampart One devices are integrated intervertebral body fusion devices 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 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 non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

### D. Comparison to Predicate Devices

When compared to the predicate devices, the subject Implants and surgical instruments have the same or equivalent:

- . Intended Use
- Indications for Use ●
- Fundamental Scientific Technology ●
- Principle of Operation ●
- Primary Design Features
- Materials of Construction ●
- . Function / Performance
- Risk Profile

### E. Non-Clinical Testing

Non-clinical testing was conducted to support the subject Implants and surgical instruments confirming function and performance.

- A review of the design changes was performed and confirmed that these modifications do not alter the intended use or present new technological characteristics.
- The design changes do not alter the primary control mechanism or operating principle.
- Benchtop mechanical ASTM testing and comparison confirmed that the subject Implants perform as intended in comparison to the primary predicate device.
- A risk assessment was performed and confirmed that the modifications introduced do not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate devices.

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### F. Conclusion

Based on the intended use, technological characteristics, and comparison to the predicate devices, Spineology has demonstrated that the subject Rampart One Implants and Class II surgical instruments have been shown to be substantially equivalent to the legally marketed predicate devices.