RELIANCE CERVICAL IBF SYSTEM

K131429 · Reliance Medical Systems, LLC · ODP · Sep 23, 2013 · Orthopedic

Device Facts

• Record ID: K131429
• Device Name: RELIANCE CERVICAL IBF SYSTEM
• Applicant: Reliance Medical Systems, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Sep 23, 2013
• 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 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 TI, 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 spacer; inserts between cervical vertebral bodies (C3-T1) to facilitate fusion; used with autogenous bone graft and supplemental spinal fixation. Implanted by surgeons in clinical settings. Device provides structural support to the anterior column of the cervical spine; benefits patients by stabilizing the intervertebral space to promote fusion in cases of discogenic neck pain.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. No clinical data provided.

Technological Characteristics

Spacer made of PEEK Optima LT1 with Tantalum markers; includes bone screws. Mechanical testing conducted per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical disc disease (neck pain of discogenic origin with confirmed 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)
• Biomet Solitaire-C System (K113796)
• Synthes Zero-P System (K121852)
• Nuvasive Coroent Small Interlock System (K102547)
• Spinal Elements Mosaic (K122771)

Submission Summary (Full Text)

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### 510(k) Summary

23 Sep 2013

SEP 2 3 2013

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

Bret M. Berry Contact: Member-Manager

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

Regulation Number: Product Code:

K131429 Intervertebral Body Fusion Device Reliance Cervical IBF System Intervertebral Body Fusion Device. Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3080 OVE, ODP

## Substantial Equivalence

The Reliance Cervical IBF is substantially equivalent to the legally marketed Reliance Cervical IBF (K120396), Biomet Solitaire-C System (K113796), the Synthes Zero-P System (K121852), Nuvasive Coroent Small Interlock System (K102547) and the Spinal Elements Mosaic (K122771). The Reliance Cervical 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 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 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 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 TI, 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.

## Performance Data and Substantial Equivalence

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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 Reliance Cervical IBF System was found to be substantially equivalent to the predicate devices. Additionally, the Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.

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Image /page/2/Picture/0 description: The image shows the logo for the 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 an abstract symbol resembling an eagle or bird with three curved lines representing its wings or body. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20093-0002

Reliance Medical Systems, LLC Mr. Bret Berry Member-Manager 545 West 500 South Suite 100 Bountiful. Utah 84010

Re: K131429 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: OVE. ODP Dated: June 24, 2013 Received: June 25, 2013

Dear Mr. Berry:

We have reviewed your Scetion 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 10 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

September 23, 2013

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### Page 2 - Mr. Bret Berry

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 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/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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#### Indications for Use

510(k) Number (if known): K131429

Device Name: Reliance CERVICAL IBF System

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 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 TI, 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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