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.

Device Description

The Fortilink-C IBF/VBR implants are manufactured from radiolucent polyetherketoneketone (PEKK) material (ASTM F2820) in various footprints and sizes. Each implant includes radiographic marker pins from tantalum (ASTM F560) and a central graft containment window. Each implant has insertion slot features on the anterior face to mate with an insertion instrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel) and 6° lordosis, and designs with and without teeth. Class II accessories and Class I (exempt) manual surgical instruments are available for use with the implants.

AI/ML Overview

This document is a 510(k) Summary for the Fortilink™-C with TETRAfuse™ 3D Technology, an intervertebral body fusion (IBF) / vertebral body replacement (VBR) device. It describes the device, its indications for use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it describes non-clinical testing performed to demonstrate "substantial equivalence" and "sufficient" mechanical strength. The "reported device performance" is a qualitative statement that the device met these objectives.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength (Static and Dynamic Axial Compression and Torsion): Demonstrate mechanical strength comparable to legally marketed predicate devices and sufficient for intended use, in accordance with ASTM F2077.	Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to the legally marketed predicate devices and sufficient for the intended use.
Subsidence Resistance (Static Subsidence): Demonstrate resistance to subsidence, in accordance with ASTM F2267.	Performed (results contributed to the conclusion of substantial equivalence and sufficient mechanical strength). Specific quantitative results are not provided in this summary.
Expulsion Resistance (Static Expulsion): Demonstrate resistance to expulsion, in accordance with Draft Standard Z8423Z (ASTM F-04.25.02.02).	Performed (results contributed to the conclusion of substantial equivalence and sufficient mechanical strength). Specific quantitative results are not provided in this summary.
Bacterial Endotoxin Levels: Meet requirements for bacterial endotoxin, in accordance with ANSI/AAMI ST-72.	Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72. (Implied that it met the standard for acceptance).
Substantial Equivalence: Demonstrate that the device is substantially equivalent to previously cleared predicate devices in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength, with no significant differences that would affect safety and effectiveness.	This submission supports the position that the subject implants are substantially equivalent to previously cleared predicate devices. The subject and predicate devices are similar in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength. There are no significant differences between the subject and predicate devices that would affect the safety and effectiveness of the Fortilink-C system. Any differences were not considered significant based on mechanical performance, bench testing.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes non-clinical (bench) testing of mechanical properties and biocompatibility.

Sample Size: The document does not specify the exact number of devices or test samples used for each mechanical test (e.g., number of constructs for axial compression). ASTM standards typically require a minimum number of samples (e.g., n=6) for such tests, but this specific detail is not provided in the summary.
Data Provenance: The data provenance is from bench testing conducted by RTI Surgical, Inc. (Pioneer Surgical Technology, Inc.), not from human clinical data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" do not directly apply in the context of human studies, as this is a device clearance based on substantial equivalence primarily supported by non-clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device clearance is based on non-clinical engineering and materials testing, not on clinical data requiring expert human review of diagnostic output or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. This document describes non-clinical laboratory testing, not a study involving human readers or interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device clearance for an orthopedic implant, not an AI/CADe/CADx system. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device clearance for an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by the validated and recognized ASTM standards (ASTM F2077, ASTM F2267) and ANSI/AAMI standard (ANSI/AAMI ST-72). The performance of the Fortilink-C device was measured against the criteria and requirements set forth in these standards, and compared to the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study requiring a training set. This is a medical implant requiring mechanical and material testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/machine learning study.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

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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.(DBA RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USAContact: Diana TaylorPhone: (386) 418-8888Fax: (386) 418-1627Prepared: 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)MQP (spinal vertebral body replacement device (VBR))
Panel/ Branch:	Orthopedic and Rehabilitation Devices Panel; Panel Code 87Anterior Spinal Devices Branch
Predicates:	• Primary Predicate: K133623, C-Plus IBF/VBR,Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc.• Additional Predicate: K142005, SpineFab® VBROxford Performance Materials, Inc.,
Description:	The Fortilink-C IBF/VBR implants are manufactured from radiolucentpolyetherketoneketone (PEKK) material (ASTM F2820) in various footprintsand sizes. Each implant includes radiographic marker pins from tantalum(ASTM F560) and a central graft containment window. Each implant hasinsertion slot features on the anterior face to mate with an insertioninstrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel)and 6° lordosis, and designs with and without teeth. Class II accessories andClass I (exempt) manual surgical instruments are available for use with theimplants.
Non-ClinicalTesting:	For a determination of substantial equivalence, static and dynamic axialcompression and torsion testing was submitted in accordance with ASTMF2077. In addition, static subsidence testing per ASTM F2267 and staticexpulsion testing per Draft Standard Z8423Z (ASTM F-04.25.02.02) wereperformed. Mechanical testing showed that the mechanical strength of thesubject system is substantially equivalent to the legally marketed predicatedevices and sufficient for the intended use.Bacterial endotoxin testing (BET) was conducted in accordance withANSI/AAMI ST-72.
Indication forUse:	The Fortilink-C interbody fusion devices are indicated for use in skeletallymature patients with degenerative disc disease (DDD) of the cervical spinewith accompanying radicular symptoms at one level or two contiguous levels.DDD is defined as discogenic pain with degeneration of the disc confirmed bypatient history and radiographic studies. The Fortilink-C devices are used tofacilitate interbody fusion in the cervical spine and are placed via an anteriorapproach from the C2-C3 disc to the C7-T1 disc using autogenous orallogenic bone graft comprised of cancellous and/or corticocancellous bonegraft. The Fortilink-C devices are to be used with supplemental fixation.Patients should have at least six (6) weeks of non-operative treatment prior totreatment with an interbody fusion device.When used as a vertebral body replacement (VBR) device, Fortilink-Cdevices are for use in the thoracolumbar spine (TI-L5) for partial replacement(i.e., partial vertebrectomy) of a diseased vertebral body resected or excisedfor the treatment of tumors in order to achieve anterior decompression of thespinal cord and neural tissues, and to restore the height of a collapsedvertebral body. VBRs are also indicated for treating fractures of the thoracicand lumbar spine. VBRs are designed to restore the biomechanical integrity ofthe anterior, middle and posterior spinal column, even in the absence of fusionfor a prolonged period of time. The VBR device is intended to be used withautogenous or allogenic bone graft and must be used with supplementalinternal fixation systems.
Conclusion:	This submission supports the position that the subject implants aresubstantially equivalent to previously cleared predicate devices.The subject and predicate devices are similar in terms of indications for use,material composition, sterilization, packaging, technological characteristics,design features, and mechanical strength.There are no significant differences between the subject and predicate devicesthat would affect the safety and effectiveness of the Fortilink-C system. Anydifferences were not considered significant based on mechanical performance,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.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.