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Flarehawk® Interbody Fusion System

With Titanium Surface Technology

TiHawk11™ utilizes Adaptive Geometry™ to expand simultaneously in width, height, and lordosis after traversing the neural corridor with a small profile. Once expanded, the conformable footprint is designed to reduce subsidence, restore foraminal height, and reestablish sagittal balance.

Titanium Surface Technology

The multi-material construct of the cage conforms to each patient’s endplate topography when expanded.  Naturally occurring deformation of a multi-material bidirectional cage may increase the bone-implant interface’s surface area and better distribute the load across the endplate.

Implant Features

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Expansive Footprint

TiHawk11 expands from 11mm to 17mm wide with a single TiHawk11 cage providing 70% more footprint than a 10mm wide cage of equivalent length. TiHawk11 enables the delivery of a 34mm wide footprint from a single-position PLIF approach.

Minimal Neural Retraction

Insertion profile as small as 7x9mm is designed to minimize neural retraction that could lead to nerve root injury. Multiple insertion profile options to help accommodate patient and level-specific neural corridors.

Maximum Graft Delivery

Open architecture allows for continuous graft delivery through the implant and into the disc space. Up to 2cm2 of bone-graft-to-endplate contact area through the open architecture of the implant.

Physician Testimonials

Dr. Peter Derman

Texas Back Institute
"These interbody cages feature multi-planar expansion, adaptive geometry, and open architecture designed to facilitate safer insertion and deployment - unique properties that can minimize subsidence and maximize fusion."

Dr. Stephen Tolhurst

Texas Back Institute
"With all titanium expandable cages, we can see subsidence due to point loading. TiHawk11 shines because of its Adaptive Geometry. The conformity of the TiHawk11 implant to the endplates when it is expanded allows for the patient's disc space to expand to its proper physiological height with the load better distributed across the entire surface of the implant. The end result is an expandable cage that conforms to the unique geometry of the disc space under load"

Dr. Kalman D. Blumberg

Florida Spine Specialists
"The titanium-bonded TiHawk11 continues the solid performance of all the Accelus interbody devices produces to far. This latest version allows a minimal insertion profile compared to its expanded size, which is especially useful for my revision cases requiring a tight dissection. I have found the performance of the TiHawk11 to be unparalleled."

INDICATIONS FOR USE/INTENDED USE

The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Refer to the FlareHawk Interbody Fusion System Instructions for Use for full prescribing information.

1. Enders JJ, Coughlin D, Mroz TE, Vira S. Surface Technologies in Spinal Fusion. Neurosurg Clin N Am. 2020 Jan;31(1):57-64. doi: 10.1016/j.nec.2019.08.007. Epub 2019 Oct 24. PMID: 31739930. 2. Kurtz, S. M., & Devine, J. N. (2007). PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials, 28(32), 4845–4869. 3. Cheng BC, Swink I, Yusufbekov R, Birgelen Michele, Ferrara L, Coric D. Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S68. Published December 1, 2020.

Accelus
  • Integrity Implants Inc. d/b/a Accelus
    354 Hiatt Drive, Suite 100
    Palm Beach Gardens, FL 33418 USA
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