Reliance Cervical IBF System

K142269 · Reliance Medical Systems, LLC · ODP · Jun 9, 2015 · Orthopedic

Device Facts

• Record ID: K142269
• Device Name: Reliance Cervical IBF System
• Applicant: Reliance Medical Systems, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jun 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RELIANCE CERVICAL 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 Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

Device Story

Reliance Cervical IBF System is an intervertebral body fusion device (spacer) for anterior cervical spine surgery. Device inserted between vertebral bodies to facilitate fusion using autogenous bone graft; requires supplemental spinal fixation. Implants manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers; includes optional bone screws. Used by surgeons in clinical settings. Provides structural support to the intervertebral space to promote spinal fusion, potentially alleviating discogenic neck pain.

Clinical Evidence

Bench testing included static compression, dynamic compression, static torsion, dynamic torsion, expulsion, and subsidence testing per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. An ovine fusion study was also performed.

Technological Characteristics

Implants made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. Mechanical testing performed per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. Device is a spacer for anterior column cervical spine fusion.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical disc disease (discogenic neck pain with degeneration) at one level from C3 to T1, following six weeks 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

• Reliance Cervical IBF (K120396)
• Reliance Cervical IBF (K131429)
• Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device (K142026)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are layered, creating a sense of depth and movement.

June 9, 2015

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

Reliance Medical Systems, LLC Mr. Bret M. Berry Owner P.O. Box 1693 Bountiful, Utah 84011

Re: K142269

Trade/Device Name: Reliance Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, OVE Dated: May 15, 2015 Received: May 14, 2015

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 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. Bret M. Berry

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

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#### K142269

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

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

510(k) Number (if known) K142269

Device Name Reliance Cervical IBF System

#### Indications for Use (Describe)

The RELIANCE CERVICAL 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 Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

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.

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### 510(k) Summary

26 October 2014

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

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 Cervical IBF System Class II. Intervertebral Body Fusion Device 21 CFR 888.3080 OVE, ODP

# Substantial Equivalence

The Reliance Cervical IBF is substantially equivalent to the legally marketed Reliance Cervical IBF (K120396 and K131429). The primary predicate is the Reliance Cervical IBF (K120396). Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device cleared in K142026 is an additional predicate device. The Reliance Cervical IBF is substantially equivalent to itself in terms of material, strength, intended use, levels of attachment, size range, and use with supplemental fixation. Mechanical testing was performed on the Reliance Cervical IBF System following ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. The mechanical testing included static compression, dynamic compression, static torsion, dynamic torsion, expulsion, and subsidence testing. Additionally, and ovine fusion study was performed.

## Device Description

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.

## Intended Use/Indications for Use

The Reliance Cervical 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 Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with

> K142269 Page 1 of 2

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degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

# Performance Data and Substantial Equivalence

Mechanical testing was performed on the Reliance Cervical IBF System following ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. The mechanical testing included static compression, dynamic compression, static torsion, dynamic torsion, expulsion, and subsidence testing. Additionally, and ovine fusion study was performed. The Reliance Cervical IBF System was found to be substantially equivalent to itself. Additionally, the Reliance Cervical IBF System is substantially equivalent to itself in terms of sterilization and biocompatibility.