Reliance Cervical IBF System

K173102 · Reliance Medical Systems, LLC · ODP · Dec 29, 2017 · Orthopedic

Device Facts

• Record ID: K173102
• Device Name: Reliance Cervical IBF System
• Applicant: Reliance Medical Systems, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Dec 29, 2017
• Decision: SESE
• Submission Type: Special
• 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 T1, for treatment of cervical disc disease (defined as 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 spacer for anterior cervical spine fusion; inserts between vertebral bodies to facilitate fusion with autogenous bone graft. System includes PEEK spacers with Tantalum markers and bone screws for fixation. Used by surgeons in clinical settings; requires supplemental spinal fixation. Benefits patients by stabilizing the intervertebral space to promote fusion in cases of degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. LAL testing performed to confirm pyrogen levels met specifications. No clinical data provided.

Technological Characteristics

Spacer composed of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. Includes bone screws. Mechanical testing per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. Provided sterile.

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. Requires use 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

• Reliance Cervical IBF (K120396)
• Reliance Cervical IBF (K131429)
• Reliance Cervical IBF (K142269)
• Reliance Cervical IBF (K172489)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K173102

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: December 12, 2017 Received: December 14, 2017

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 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);

December 29, 2017

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K173102

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 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 as 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) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

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#### 510(k) Summary

12th December 2017

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:

Intervertebral Body Fusion Device Common or Usual Name: Proposed Proprietary or Trade Name: Reliance Cervical IBF System Classification Name: Intervertebral Body Fusion Device, Spinal Intervertebral Body Fixation Orthosis Regulation Number: 21 CFR 888.3080 Product Code: ODP, OVE

### Substantial Equivalence

The Reliance Cervical IBF is substantially equivalent to the legally marketed Reliance Cervical IBF (K120396, K131429, K142269 & K172489). 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 is made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System also includes 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 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.

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## Non-Clinical Testing

The Reliance Cervical IBF System (K120396, K131429, K142269 & K172489) has undergone Non-Clinical Testing using various ASTM Standards at a third party facility. 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 standards. The subject Reliance Cervical IBF System has the same material, design, sizes, indication of use & biocompatibility as the predicate devices.

## Technological Modifications

The subject Reliance Cervical IBF System differs from the predicate devices in terms of method of sterilization and packaging.

LAL testing to test the pyrogen levels have been performed & the specifications have been met.

## Conclusion

The validation methods demonstrated that the Reliance Cervical IBF System may be provided sterile.