Reliance Cervical IBF System

K202266 · Reliance Medical Systems, LLC · ODP · Mar 29, 2022 · Orthopedic

Device Facts

• Record ID: K202266
• Device Name: Reliance Cervical IBF System
• Applicant: Reliance Medical Systems, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Mar 29, 2022
• 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 system devices 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 degenerative disc disease (DDD is 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 consists of additively manufactured titanium spacers for anterior cervical interbody fusion. Spacers are inserted between vertebral bodies to facilitate fusion in conjunction with autogenous bone graft and supplemental fixation. Used by surgeons in clinical settings. Device provides structural support to the intervertebral space to treat degenerative disc disease. Benefits include stabilization of the spinal segment to promote fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-18 and F2267-04. Cleaning, sterilization, and packaging validation performed per relevant ASTM and ANSI/AAMI/ISO standards to address the new porous lattice structure.

Technological Characteristics

Material: Titanium 6Al-4V ELI (ASTM F3001). Design: Additively manufactured porous lattice structure. Principle: Intervertebral body spacer for fusion. Sterilization: Validated per ANSI/AAMI/ISO 11137 series. No software or electronic components.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical degenerative disc disease (DDD) 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 System (K120396, K131429, K172489, K173102)
• Nexxt Spine Matrixx System (K171140)

Submission Summary (Full Text)

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March 29, 20222

Reliance Medical Systems, LLC Bret Berry Owner P.O. Box 1693 Bountiful, Utah 84010

Re: K202266

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 Dated: February 24, 2022 Received: February 28, 2022

Dear Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202266

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 system devices 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 degenerative disc disease (DDD is 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

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: K202266 Common or Usual Name: Intervertebral Body Fusion Device Proposed Proprietary or Trade Name: Reliance Cervical IBF System Classification Name: Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Product Code: ODP

### Substantial Equivalence:

The subject Reliance Cervical IBF System is substantially equivalent to the legally marketed predicate devices, the Reliance Cervical IBF System (K120396/K131429/K172489/ K173102, with K173102 as the primary predicate) and the Nexxt Spine Matrixx System (K171140). The subject Reliance Cervical IBF System is equivalent to its commercially available predicates in terms of intended use, indications for use, design, function, principle of operation, materials, levels of attachment, size range, strength and use with supplemental fixation.

#### Device Description:

The Reliance Cervical IBF System is comprised of implant 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 subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.

#### Intended Use / Indications for Use:

The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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.

29 March 2022

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The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is 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.

### Technological Modifications:

The subject Reliance Cervical IBF system offers intervertebral body spacers in an additional material, Titanium 6A1-4V ELI. There have been no changes to intended use, indications for use, function, principle of operation, sizes or size range, levels of attachment, or method of insertion.

### Performance Data and Substantial Equivalence:

The Reliance Cervical IBF device was subjected to performance testing that followed ASTM F2077-18 and F2267-04 (2018) standards. Additionally, the porous lattice structures within the implants presented a new worst-case scenario for sterilization, cleaning and packaging. Therefore, packaging testing was performed according to the following ASTM standards: D4169, D4332, F88, F1886 and F2096, and cleaning validation in accordance to the following ASTM standards: F2459 and F2847. Sterilization was performed to the following standards: ANSI/AAMI/ISO 11137-1:2006/A1:2013/A2:2019, ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006, ANSI/AAMI/ISO 11737-2:2009, and ANSI/AAMI/ISO TIR13004:2013. The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of biocompatibility.