Rampart-T Interbody Fusion System

K151020 · Spineology, Inc. · MAX · Jul 22, 2015 · Orthopedic

Device Facts

• Record ID: K151020
• Device Name: Rampart-T Interbody Fusion System
• Applicant: Spineology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 22, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rampart-T implants are 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 six months of non-operative treatment. Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Story

Rampart-T Interbody Fusion System is a spinal implant for intervertebral body fusion; used in lumbar spine (L2-S1). Device is a tapered, crescent-shaped PEEK-OPTIMA LT1 implant with tantalum markers for radiographic visualization; features toothed fish-scale surface design for endplate interface. Implanted by surgeons during spinal fusion procedures; requires use of autograft and supplemental fixation systems. Tapered leading end facilitates insertion; maintains 6-degree lordotic angle. Benefits include stabilization of disc space to promote fusion in patients with DDD.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing performed in accordance with FDA guidance for Intervertebral Body Fusion Devices and ASTM standards F2077 and F2267, including static and dynamic compression, shear, subsidence, and expulsion testing.

Technological Characteristics

Material: PEEK-OPTIMA LT1; Tantalum alloy markers. Form factor: Tapered, crescent-shaped interbody spacer with 6-degree lordotic angle. Surface: Toothed fish-scale design. Standards: ASTM F2077 (test methods for intervertebral body fusion devices), ASTM F2267 (test method for measuring load-induced subsidence).

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade I spondylolisthesis, following six months of failed 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 LIFD (K110933)
• K111880
• K132053
• K113030

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 22, 2015

Spineology, Incorporated Ms. Karen Roche Vice President, Operations & Technology 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K151020

Trade/Device Name: Rampart™T Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 24, 2015 Received: June 24, 2015

Dear Ms. Roche:

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

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

Page 2 - Ms. Karen Roche

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/Resourcesfor You/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 vours.

# 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)

#### K151020

Device Name Rampart™-T Interbody Fusion System

#### Indications for Use (Describe)

Rampart-T implants are 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 six months of non-operative treatment.

Rampart-T implants are designed for use with autograft to facilitate fusion and are 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)

> 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

# I. SUBMITTER

Spineology Inc. 7800 3rd Street N., Suite 600 Saint Paul, MN 55128

Phone: [phone] Fax: [phone]

Contact Person: Karen Roche Date Prepared: July 15, 2015

# II. DEVICE

Name of Device: Rampart™-T Interbody Fusion System Common Name or usual name: Intervertebral fusion device with bone graft, lumbar Classification Name: Intervertebral body fusion device (21 CFR §888.3080) Regulatory Class: Class II Product Code: MAX

### III. PREDICATE DEVICE

Spineology PEEK LIFD K110933 (Primary Predicate), K111880, K132053, K113030 (Additional Predicates)

#### DEVICE DESCRIPTION IV.

The Spineology Rampart™-T Interbody Fusion implant is a tapered version of the predicate Spineology PEEK Crescent implant. The subject and predicate devices are composed of PEEK -OPTIMA® LT1 (polyetheretherketone). The subject device and the primary predicate are both manufactured as a curved (crescent) shape and contain two areas for the placement of autograft. Additionally, the subject and predicate devices contain tantalum alloy markers to assist in device placement through intraoperative imaging. The devices all have a toothed fish-scale style antibackout design on the surfaces that interface with the vertebral body endplates. The subject device is tapered at its leading end for ease of initial implantation and will maintain the same 6 degree lordotic angle to accommodate a suitable fit in the disc space.

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

#### V. INDICATIONS FOR USE

Rampart-T implants are 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 of non-operative treatment.

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

#### COMPARISON OF TECHNOLOGICAL FEATURES WITH THE PREDICATE VI. DEVICE

The Spineology Rampart-T Interbody Fusion Implant shares the same indications, materials, function, and performance as the predicate implants.

# VII. PERFORMANCE DATA

The Rampart-T Interbody Fusion System has previously undergone performance testing. The testing was performed in accordance with the FDA's guidance titled: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Additionally preclinical testing was performed in accordance with ASTM F2077 and ASTM F2267. This testing included static compression shear, shear, and dynamic axial and shear compression, subsidence and expulsion. This testing has been previously submitted and reviewed by the FDA.

# VII. CONCLUSIONS

The Rampart-T Interbody implant is substantially equivalent to the cited predicate implants. This conclusion is based on a comparison of intended use, materials, technological features, and comparative performance testing.