RELIANCE LUMBAR IBF SYSTEM

K113540 · Reliance Medical Systems, LLC · MAX · Mar 12, 2012 · Orthopedic

Device Facts

• Record ID: K113540
• Device Name: RELIANCE LUMBAR IBF SYSTEM
• Applicant: Reliance Medical Systems, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Mar 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Device Story

Reliance Lumbar IBF System consists of PEEK Optima LT1 spacer with Tantalum markers; designed for insertion between vertebral bodies in anterior lumbar spine. Used by surgeons in clinical settings to facilitate fusion in patients with DDD. Device acts as structural spacer; requires concurrent use of autogenous bone graft and supplemental spinal fixation. Benefits include stabilization of intervertebral space to promote fusion. No electronic or software components.

Clinical Evidence

Bench testing only. Static and dynamic compression testing per ASTM F2077-03; subsidence testing per ASTM F2267-04; static push-out testing per ASTM Draft F-04.25.02.02.

Technological Characteristics

Spacer composed of PEEK Optima LT1 with Tantalum markers. Mechanical testing performed per ASTM F2077-03, ASTM F2267-04, and ASTM Draft F-04.25.02.02. Non-electronic, mechanical implant.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one or two contiguous levels (L2-S1). Requires six months of prior non-operative treatment. Must be used with autogenous bone graft and supplemental spinal fixation.

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

• Alphatec NOVEL System (K090782)
• Stryker AVS System (K090816)
• Globus Patriot System (K093242)
• US Surgical Ray Threaded Fusion Cage (P950019)
• Depuy I/F Cage (P960025)

Submission Summary (Full Text)

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K113540

MAR 1 2 2012

## 510(k) Summary

Date: 8 March 2012

Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 801-295-3280 Telephone: [phone] Fax:

### Contact: Bret M. Berry Member-Manager

510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:

Intervertebral Body Fusion Device Reliance Lumbar IBF System Intervertebral Body Fusion Device 21 CFR 888.3080 MAX

## Substantial Equivalence

The Reliance Lumbar IBF is substantially equivalent to the legally marketed Alphatec NOVEL System (K090782), the Stryker AVS System (K090816), the Globus Patriot System (K093242), the US Surgical Ray Threaded Fusion Cage (P950019), and the Depuy I/F Cage (P960025), The Reliance Lumbar IBF is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

## Device Description

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK Optima LT1 with Tantalum markers.

# Intended Use/Indications for Use

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

pegn. 1 of 2

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# Performance Data and Substantial Equivalence

Mechanical testing was performed on the worst case Reliance Lumbar IBF device following ASTM Standards. Static and Dynamic Compression testing was performing following ASTM Standard F2077-03, Subsidence Testing was performed following ASTM F2267-04, and Static Push-out Testing was performed following ASTM Draft F-04.25.02.02. The Reliance Lumbar IBF was found to be substantially equivalent to the predicate devices.

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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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

### Public Health Service

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

Reliance Medical Systems, LLC % Mr. Bret M. Berry 545 West 500 South, Suite 100 Bountiful, Utah 84010

MAR 1 2 2012

Re: K113540

Trade/Device Name: LUMBAR IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 20, 2012 Received: February 21, 2012

Dear Mr. Berry:

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

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# Page 2 - Mr. Bret M. Berry

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours.

Mark N. Millers

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

Enclosure

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# Indications for Use

# 510(k) Number (if known): K113540

Device Name: Reliance LUMBAR IBF System

Indications for Use:

The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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KIJ3540 510(k) Number_