Fortilink™-C with TETRAfuse™ 3D Technology

K163673 · Rti Surgical, Inc. · ODP · May 23, 2017 · Orthopedic

Device Facts

• Record ID: K163673
• Device Name: Fortilink™-C with TETRAfuse™ 3D Technology
• Applicant: Rti Surgical, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: May 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fortilink-C interbody fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Fortilink-C devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc to the C7-T1 disc using autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Fortilink-C devices are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device. When used as a vertebral body replacement (VBR) device, Fortilink-C devices are for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with autogenous or allogenic bone graft and must be used with supplemental internal fixation systems.

Device Story

Fortilink-C is an interbody fusion/vertebral body replacement (VBR) implant; manufactured from radiolucent PEKK; features tantalum radiographic marker pins; includes central graft containment window; designed for anterior cervical approach or thoracolumbar VBR. Implanted by surgeons in clinical settings to facilitate fusion or restore spinal biomechanical integrity; used with autogenous or allogenic bone graft and supplemental internal fixation. Device provides structural support to spinal column; aids in decompression and height restoration. Benefits include stabilization of diseased or fractured spinal segments.

Clinical Evidence

Bench testing only. Performed static and dynamic axial compression and torsion testing (ASTM F2077), static subsidence testing (ASTM F2267), and static expulsion testing (Draft Standard Z8423Z). Bacterial endotoxin testing conducted per ANSI/AAMI ST-72.

Technological Characteristics

Material: PEKK (ASTM F2820); Radiographic markers: Tantalum (ASTM F560). Design: Various footprints/sizes, 0°/6° lordosis, with/without teeth. Central graft containment window. Insertion slot for instrumentation. Non-implantable accessories/instruments available.

Indications for Use

Indicated for skeletally mature patients with cervical DDD (one or two levels) with radicular symptoms, or thoracolumbar spine (T1-L5) patients requiring partial vertebral body replacement due to tumors or fractures. Contraindications include patients without skeletal maturity or those not requiring supplemental 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

• C-Plus IBF/VBR (K133623)
• SpineFab® VBR (K142005)

Submission Summary (Full Text)

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

RTI Surgical, Inc. Diana Taylor Senior Regulatory Affairs Specialist 11621 Research Circle Alachua, Florida 32615

May 23, 2017

Re: K163673

Trade/Device Name: Fortilink™-C with TETRAfuse™ 3D Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: April 21, 2017 Received: April 24, 2017

Dear Ms. Taylor:

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

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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 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. 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.

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,

# 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) K163673

Device Name

Fortilink™-C with TETRAfuse™ 3D Technology

#### Indications for Use (Describe)

The Fortilink-C interbody fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Fortilink-C devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc to the C7-T1 disc using autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Fortilink-C devices are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.

When used as a vertebral body replacement (VBR) device, Fortilink-C devices are for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. V BRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with autogenous or allogenic bone graft and must be used with supplemental internal fixation systems.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;">☒</span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="margin-right:5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in white on a blue rounded square, followed by the word "surgical" in gray. The logo is simple and modern, and it is likely used to identify the company and its products.

## 510(k) Summary Pursuant to 21 CFR 807.92

| Sponsor: | Pioneer Surgical Technology, Inc.<br>(DBA RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA<br>Contact: Diana Taylor<br>Phone: [phone]<br>Fax: [phone]<br>Prepared: May 22, 2017 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | Cervical Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) |
| Trade names: | FortilinkTM-C with TETRAfuseTM 3D Technology |
| Common name: | Intervertebral Body Fusion / Vertebral Body Replacement Implants |
| Classifications: | 21 CFR 888.3080 and 21 CFR 888.3060 – Class II |
| Product Codes: | ODP (Intervertebral fusion device (IBF) with bone graft, cervical)<br>MQP (spinal vertebral body replacement device (VBR)) |
| Panel/ Branch: | Orthopedic and Rehabilitation Devices Panel; Panel Code 87<br>Anterior Spinal Devices Branch |
| Predicates: | • Primary Predicate: K133623, C-Plus IBF/VBR,<br>Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc.<br>• Additional Predicate: K142005, SpineFab® VBR<br>Oxford Performance Materials, Inc., |
| Description: | The Fortilink-C IBF/VBR implants are manufactured from radiolucent<br>polyetherketoneketone (PEKK) material (ASTM F2820) in various footprints<br>and sizes. Each implant includes radiographic marker pins from tantalum<br>(ASTM F560) and a central graft containment window. Each implant has<br>insertion slot features on the anterior face to mate with an insertion<br>instrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel)<br>and 6° lordosis, and designs with and without teeth. Class II accessories and<br>Class I (exempt) manual surgical instruments are available for use with the<br>implants. |
| Non-Clinical<br>Testing: | For a determination of substantial equivalence, static and dynamic axial<br>compression and torsion testing was submitted in accordance with ASTM<br>F2077. In addition, static subsidence testing per ASTM F2267 and static<br>expulsion testing per Draft Standard Z8423Z (ASTM F-04.25.02.02) were<br>performed. Mechanical testing showed that the mechanical strength of the<br>subject system is substantially equivalent to the legally marketed predicate<br>devices and sufficient for the intended use.<br>Bacterial endotoxin testing (BET) was conducted in accordance with<br>ANSI/AAMI ST-72. |
| Indication for<br>Use: | The Fortilink-C interbody fusion devices are indicated for use in skeletally<br>mature patients with degenerative disc disease (DDD) of the cervical spine<br>with accompanying radicular symptoms at one level or two contiguous levels.<br>DDD is defined as discogenic pain with degeneration of the disc confirmed by<br>patient history and radiographic studies. The Fortilink-C devices are used to<br>facilitate interbody fusion in the cervical spine and are placed via an anterior<br>approach from the C2-C3 disc to the C7-T1 disc using autogenous or<br>allogenic bone graft comprised of cancellous and/or corticocancellous bone<br>graft. The Fortilink-C devices are to be used with supplemental fixation.<br>Patients should have at least six (6) weeks of non-operative treatment prior to<br>treatment with an interbody fusion device.<br>When used as a vertebral body replacement (VBR) device, Fortilink-C<br>devices are for use in the thoracolumbar spine (TI-L5) for partial replacement<br>(i.e., partial vertebrectomy) of a diseased vertebral body resected or excised<br>for the treatment of tumors in order to achieve anterior decompression of the<br>spinal cord and neural tissues, and to restore the height of a collapsed<br>vertebral body. VBRs are also indicated for treating fractures of the thoracic<br>and lumbar spine. VBRs are designed to restore the biomechanical integrity of<br>the anterior, middle and posterior spinal column, even in the absence of fusion<br>for a prolonged period of time. The VBR device is intended to be used with<br>autogenous or allogenic bone graft and must be used with supplemental<br>internal fixation systems. |
| Conclusion: | This submission supports the position that the subject implants are<br>substantially equivalent to previously cleared predicate devices.<br>The subject and predicate devices are similar in terms of indications for use,<br>material composition, sterilization, packaging, technological characteristics,<br>design features, and mechanical strength.<br>There are no significant differences between the subject and predicate devices<br>that would affect the safety and effectiveness of the Fortilink-C system. Any<br>differences were not considered significant based on mechanical performance,<br>bench testing. |

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Image /page/4/Picture/0 description: The image shows the logo for "rti surgical". The logo consists of the letters "rti" in a blue rounded square with a small green leaf on the top right corner of the "i". To the right of the square is the word "surgical" in gray.