RAMPART O

K131216 · Spineology, Inc. · MAX · May 30, 2013 · Orthopedic

Device Facts

• Record ID: K131216
• Device Name: RAMPART O
• Applicant: Spineology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 30, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rampart™ O 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 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. These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach. Rampart™ O 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™ O is an intervertebral body fusion device used in lumbar spine surgery. It is implanted by a surgeon via open or minimally invasive posterior or transforaminal approaches, either singly or in pairs. The device acts as a structural spacer to facilitate fusion when used with autograft and supplemental fixation systems. It is available in various lordotic and non-lordotic sizes to accommodate patient anatomy. The device provides mechanical support to the intervertebral space, promoting spinal stability and fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Preclinical testing performed according to ASTM F2077, including static compression and static compression shear, demonstrated performance characteristics equivalent to the predicate devices.

Technological Characteristics

Intervertebral body fusion device; available in lordotic and non-lordotic configurations; provided non-sterile; mechanical performance validated per ASTM F2077.

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) 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 Devices (K111880, K113030, K120293, K123652, K130396)

Submission Summary (Full Text)

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# 510(k) Summary

# MAY 3 0 2013

| Applicant: | Spineology Inc.<br>7800 3rd Street N., Suite 600<br>Saint Paul, MN 55128<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bryan Becker |
| Date Prepared: | April 2, 2013 |
| Trade Name: | Rampart™ O |
| Product Classification<br>and Code: | Class II Medical Device, Product Code MAX, 21 CRF 888.3080 |
| Predicate Device(s): | Spineology PEEK Lumbar Interbody Fusion Devices (K111880,<br>K113030, K120293, K123652 and K130396) |
| Device Description: | Rampart™ O devices are designed for use with autograft as an adjunct to<br>fusion and are intended for use with supplemental fixation systems cleared<br>for use in the lumbar spine. The device is available in a range of lengths<br>and heights. The device and associated instruments are provided non-<br>sterile. |
| Intended Use: | Rampart™ O is an intervertebral body fusion device indicated for<br>intervertebral body fusion at one level or two contiguous levels in the<br>lumbar spine from L2 to S1 in patients with degenerative disc disease<br>(DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD<br>is defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by patient history and radiographic studies. These patients<br>should be skeletally mature and have had six months of non-operative<br>treatment.<br><br>These devices may be implanted singly or in pairs via an open or a<br>minimally invasive posterior or transforaminal approach.<br><br>Rampart™ O is designed for use with autograft as an adjunct to fusion<br>and is intended for use with supplemental fixation systems cleared by the<br>FDA for use in the lumbar spine. |
| Purpose of this 510(k): | The purpose of this 510(k) is to extend the range of sizes of Rampart O<br>lordotic and non-lordotic implants. |
| Summary of<br>Technological<br>Characteristics: | The device is shown to be substantially equivalent to the intended use,<br>materials, configuration, and performance characteristics of the predicate<br>products. |

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| Testing | Previous preclinical testing according to ASTM F2077, including static compression and static compression shear was used to justify substantial equivalence. This testing demonstrated similar performance characteristics to the identified predicate devices. |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The information submitted in this premarket notification supports a determination that RampartTM O is substantially equivalent in technological characteristics and intended use to the predicate device. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three wavy lines extending from its body, possibly representing water or movement.

#### Public Health Service

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

May 30, 2013

Spineology. Incorporated % Mr. Brvan Becker Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K131216

Trade/Device Name: Rampart™ O Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 29, 2013 Received: April 30, 2013

Dear Mr. Becker:

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

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# Page 2 - Mr. Bryan Becker

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

For

Sincerely yours.

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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known): K131216

### Device Name: Rampart™ O

Indications for Use:

Rampart™ O 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 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.

These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.

Rampart™ O 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:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of-CDRH, Office of-Device-Evaluation-(ODE)-

Anton E. Dmitřiev, PhD Division of Orthopedic Devices

Premarket Notification for Rampart O Fusion Devices

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