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Fortilink™-C with TETRAfuse™ 3D Technology

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163673

by Rti Surgical, Inc.

Identifiers

510(k) Number
K163673 FDA 510(k)
FDA Product Code
ODP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fortilink-C with TETRAfuse 3D Technology is a Cervical Interbody Fusion Device (Product Code: ODP) designed for spinal fusion procedures. It features a 3D-printed interbody material with a TETRAfuse pattern to enhance osseointegration, ensuring a deeper bone-implant connection. The device is radiolucent, allowing for clear radiographic visualization during placement.

This device is supplied as a sterile, single-use implant intended for cervical interbody fusion from the C2-C3 to C7-T1 disc spaces. It includes three radiographic markers to confirm anterior/posterior and lateral positioning. Authorized under FDA 510(k) clearance (K163673), it is classified under the Orthopedic advisory committee and is not MRI-safe. Storage and handling must comply with sterile surgical instrument protocols.

Frequently asked questions

What cervical disc spaces is the Fortilink-C with TETRAfuse 3D Technology approved for use in during spinal fusion procedures?

The Fortilink-C with TETRAfuse 3D Technology is specifically designed for cervical interbody fusion procedures at the C2-C3 through C7-T1 disc spaces. This range ensures compatibility with the upper and mid-cervical spine, where such fusion techniques are commonly applied.

How does the TETRAfuse 3D Technology in this device improve bone integration compared to traditional implants?

The TETRAfuse 3D Technology features a 3D-printed interbody material with a unique pattern designed to enhance osseointegration. This pattern promotes a deeper and stronger connection between the implant and surrounding bone, improving stability and fusion outcomes during cervical interbody fusion.

Is the Fortilink-C with TETRAfuse 3D Technology reusable, or is it intended for single-use only?

The Fortilink-C with TETRAfuse 3D Technology is explicitly supplied as a sterile, single-use implant. This ensures patient safety and maintains the integrity of the device’s design, particularly its 3D-printed structure and osseointegration features, which are not intended for reuse.

Does this device allow for clear radiographic visualization during placement, and if so, how?

Yes, the Fortilink-C with TETRAfuse 3D Technology is radiolucent, meaning it allows X-rays to pass through easily. This enables clear radiographic visualization during placement, helping surgeons confirm proper positioning with three integrated radiographic markers for anterior/posterior and lateral orientation.

What storage and handling precautions should be taken with the Fortilink-C with TETRAfuse 3D Technology?

The device must be stored and handled according to sterile surgical instrument protocols to maintain its sterility. Since it is single-use, it should remain in its original packaging until immediately before use, and any exposure to non-sterile environments should be minimized to preserve its integrity and safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fortilink®-C with TETRAfuse® 3D Technology - Xtant Medical, PDF Fortilink-C - neurospineproductreview.com, PDF Fortilink-C F - xtantmedical.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rti Surgical, Inc.

Sources (1)

  • FDA 510(k) K163673 24 fields · synced Sep 19, 2026