FlareHawk TiHawk9 Interbody Fusion System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201367 FDA 510(k)
- FDA Product Code
- MAX 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 FlareHawk TiHawk9 Interbody Fusion System is an interbody spinal implant designed for posterior lumbar intervertebral fusion. It features adaptive geometry that expands in width, height, and lordosis to restore spinal alignment and foraminal height while minimizing neural corridor disruption.
This system is supplied as a single-use, non-sterile device intended for surgical use after discectomy. It requires sterilization by the facility prior to implantation and is regulated under FDA 510(k) clearance (K201367) and MDD compliance. The TiHawk9 model is available in specific sizes for use in lumbar levels L2 to S1.
Frequently asked questions
What spinal levels is the FlareHawk TiHawk9 Interbody Fusion System designed for, and how does its adaptive geometry benefit patients?
The FlareHawk TiHawk9 is specifically designed for posterior lumbar intervertebral fusion at levels L2 through S1. Its adaptive geometry allows the implant to expand in width, height, and lordosis, which helps restore natural spinal alignment and increase foraminal height. This design minimizes disruption to the neural corridor, potentially reducing postoperative nerve irritation and improving patient outcomes.
Is the FlareHawk TiHawk9 system single-use or reusable, and what sterilization steps are required before surgery?
The FlareHawk TiHawk9 is supplied as a single-use, non-sterile device. Since it is not pre-sterilized, the surgical facility must sterilize it using their standard protocols before implantation. This ensures compliance with sterile surgical practices and device safety.
How do I determine the correct size for a patient’s anatomy when using the TiHawk9 model?
The TiHawk9 model comes in specific sizes tailored for lumbar levels L2 to S1. The exact sizing should be determined by the surgeon based on preoperative imaging (e.g., CT or MRI scans) to match the patient’s intervertebral space dimensions. Integrity Implants provides sizing guides, but final selection depends on intraoperative assessment to ensure proper fit and spinal restoration.
What regulatory pathways does the FlareHawk TiHawk9 follow, and how does this affect its availability?
The FlareHawk TiHawk9 Interbody Fusion System is cleared under FDA 510(k) (K201367) and complies with the MDD (Medical Device Directive). This means it is legally marketed in the U.S. and EU (where applicable) after meeting regulatory requirements. Availability depends on local regulatory approvals, but the device is distributed by Integrity Implants Inc. in compliance with these pathways.
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: FlareHawk® Interbody Fusion System - Highridge Medical, FlareHawk TiHawk9 Interbody Fusion System (K201367) - FDA 510(k), FlareHawk TiHawk9 Interbody Fusion System (K201367) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201367 | Class II | Active |
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Manufacturer
- Manufacturer
- Integrity Implants Inc.
- FDA Applicant
- Integrity Implants, Inc.
Sources (2)
- FDA 510(k) K201367 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026