FlareHawk® Expandable Lumbar
Interbody Fusion System
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.
Utilizing a propriety ion beam-assisted deposition process, a uniform non-porous, 0.5-micron-thick layer of titanium is deposited through a high-vacuum, low-temperature bombardment that intermixes the titanium and PEEK atoms at the bonding interface. This process provides a strong titanium/PEEK adhesion without the loss of fluoroscopic visualization, and unlike conventional physical vapor deposition coatings, which rest only on the surface, the concurrent ion bombardment intermixes coating substrate atoms and significantly improves adhesion.
Stiffness properties comparable to bone, inertness and biocompatibility.1,2
Roughened titanium has properties that may allow for enhanced bone fixation against surfaces.3
The combination of PEEK and titanium may permit a modulus more similar to bone, and allow for fluoroscopic visualization (when the titanium deposition layer is thinly applied), and potentially overcome concerns regarding the inertness of PEEK and limited fixation with bone.4,5
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.
- 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.
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.
- 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.
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. Warburton, A., Girdler, S. J., Mikhail, C. M., Ahn, A., & Cho, S. K. (2020). Biomaterials in Spinal Implants: A Review. Neurospine, 17(1), 101–110. https://doi.org/10.14245/ns.1938296.148. 2. Ong, Y. (2015). New biomaterials for orthopedic implants. Orthopedic Research and Reviews, 7, 107–129. https://doi.org/10.2147/ORR.S63437. 3. Ratner, B. D. (2004). Biomaterials science: An introduction to materials in medicine. Amsterdam: Elsevier Academic Press. 4. 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. 5. Kurtz, S. M., & Devine, J. N. (2007). PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials, 28(32), 4845–4869. 6. 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.