Rampart D Lumbar Interbody Fusion Device

K160074 · Spineology, Inc. · MAX · Oct 18, 2016 · Orthopedic

Device Facts

• Record ID: K160074
• Device Name: Rampart D Lumbar Interbody Fusion Device
• Applicant: Spineology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rampart™ D Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 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. The Rampart™ D device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft 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

Intervertebral body fusion device providing mechanical support within the intradiscal space; adjunct to fusion. Implant features PEEK-OPTIMA LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum markers; includes rounded nose for insertion and ridged teeth to resist migration; porous central cavity for graft containment. Used in lumbar spine surgery; implanted by surgeons. Requires use with autograft/allograft and supplemental fixation systems. Benefits include stabilization of the spinal segment to facilitate fusion in patients with DDD.

Clinical Evidence

Supported by non-clinical bench testing (ASTM F2077 static/dynamic axial compression and compression shear; ASTM F2267 subsidence; expulsion; particulate analysis; load sharing) and cadaveric implantation evaluations. Patient-level clinical data supplemented by literature review provided to support substantial equivalence.

Technological Characteristics

Materials: PEEK-OPTIMA LT-1, titanium alloy, polyethylene terephthalate (PET), tantalum markers. Design: Interbody spacer with porous central cavity, rounded nose, and ridged teeth. Testing standards: ASTM F2077, ASTM F2267. Provided sterile.

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-L5) 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

• Rampart™L (K133371)
• Interfuse L (K131540)
• Elite L Expandable Lumbar Fusion System (K150954)

Reference Devices

• OptiMesh (K014200)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of a human figure in profile, with three overlapping faces suggesting community and support. The overall design is simple and professional, reflecting the department's role in public health and human services.

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

October 18, 2016

Spineology Inc. Ms. Karen Roche VP. Operations & Technology 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K160074

Trade/Device Name: Rampart™ D Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 7, 2016 Received: September 8, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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,

# 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160074

K160074

Page 1 of 1

Device Name

Rampart™ D Lumbar Interbody Fusion Device

#### Indications for Use (Describe)

The Rampart™ D Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 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. The Rampart™ D device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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 [e-mail]

"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

| Applicant: | Spineology Inc.<br>7800 3rd Street N., Suite 600<br>Saint Paul, MN 55128-5455<br>Phone: [phone]<br>Fax: [phone] | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Karen Roche | |
| Date Prepared: | October 17, 2016 | |
| Trade Name: | Rampart™ D Lumbar Interbody Fusion Device | |
| Common Name: | Interbody Spacer | |
| Product Classification<br>and Name: | 21 CFR § 888.3080 - Intervertebral body fusion device<br>(Class II, Special Controls) | |
| Product Code: | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Predicate Device(s): | Primary Predicate: | Rampart™L (K133371); Spineology Inc. |
| | Additional Predicates: | 1. Interfuse L (K131540);<br>Vertebral Technologies, Inc. |
| | | 2. Elite L Expandable Lumbar Fusion System<br>(K150954); Innova Spinal Technologies, LLC |
| Reference Device: | OptiMesh (K014200); Spineology Inc. | |
| Device Description: | The Rampart™D Lumbar Interbody Fusion Device is an intervertebral<br>implant designed to provide mechanical support within the<br>intradiscal space as an adjunct to fusion. The device is made of<br>PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate<br>(PET), and tantalum markers. It is available in varying lengths and<br>heights with two lordotic configurations, and is provided sterile. It is<br>designed with a porous central cavity for graft containment. The<br>device features a rounded nose to aid implant insertion and includes<br>ridged teeth to resist migration. | |
| Indications for Use: | The Rampart™D Lumbar Interbody Fusion Device is indicated for<br>intervertebral body fusion at one level or two contiguous levels in<br>the lumbar spine from L2 to L5 in patients with degenerative disc<br>disease (DDD) with up to Grade I spondylolisthesis at the involved<br>level(s). DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by patient history and<br>radiographic studies. These patients should be skeletally mature and | |
| | have had six months of non-operative treatment. The Rampart D<br>device is designed for use with autograft and/or allograft comprised<br>of cancellous and/or corticocancellous bone graft as an adjunct to<br>fusion and is intended for use with supplemental fixation systems<br>cleared by the FDA for use in the lumbar spine. | |
| Purpose of this 510(k): | To receive FDA clearance to market the Rampart D Lumbar<br>Interbody Fusion Device in the US. | |
| Summary of<br>Technological<br>Characteristics: | The Rampart D Lumbar Interbody Fusion Device and the predicates<br>share some technological characteristics, including materials of<br>construction, comparable profile, dimensions and lordotic angles,<br>serrated surfaces for endplate contact, similar graft containment<br>areas and graft volume capacities. The reference device shares the<br>same material and design features for use in graft containment. | |
| Testing | Non-clinical testing was performed according to ASTM F2077 (static<br>and dynamic axial compression and compression shear), ASTM F2267<br>(subsidence) and expulsion testing. Particulate analysis, bench-top<br>and cadaveric implantation evaluations and load sharing tests were<br>completed. All testing was conducted on worst case configurations for<br>both sizing and recommended graft fill. Existing biological data on<br>device materials was used to support the performance and biological<br>safety of the device. Patient-level clinical data that was supplemented<br>with a literature review was also provided to support the substantial<br>equivalence of the subject device. | |
| Conclusion: | The Rampart D device has the same intended use and Indications for<br>Use statement as the predicate devices identified. The differences<br>in technological characteristics between Rampart D and the<br>predicate devices do not raise different safety or effectiveness<br>questions. Non-clinical and clinical testing demonstrates substantial<br>equivalence to legally marketed predicate devices when used under<br>the labeled conditions. | |

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