iFuse Granite Onyx™
Features
- Poly-Axial Tulip Up to 60 degrees of angulation with general rod compatibility (5.0, 5.5, 6.0 mm Ti alloy or CoCr)
- Full Height Thread Stop No thread lead out for increased proximal engagement
- Dual Diameter Increased proximal engagement
- Anatomy Specific Design Thin crested threads designed to reduce pull-out and thick crested threads designed to reduce toggle
- Trabecular Lattice Surface Mimics cancellous bone, providing a favorable environment for bone ingrowth and ongrowth
- Vertebral Body Fenestrations Designed to capture bone during insertion and to allow bone through growth
FDA: Breakthrough Device Designation
Video
Results
3-Week Preclinical Histology
iFuse Granite Onyx
Machined Pedicle Screw
iFuse Granite Onyx shows sheep bone ingrowth and ongrowth with its porous surface. Histologic imaging of the iFuse Granite Onyx at 3 weeks signifies through growth.
SI-BONE Technical Study 303358-TS. Sheep model data is not necessarily indicative of human clinical outcomes.
Progressive Fixation Through Osseointegration
iFuse Granite Onyx has a higher removal torque than a machined pedicle screw.
Details
News
Latest News for iFuse Granite Onyx
NTAP Candidate
FY28
Candidate for FY28 New Technology Add-on Payment (NTAP)
As a current BDD holder, and prospective NTAP applicant, Onyx will be a candidate for a future FY 2028 New Technology Add-on Payment (NTAP) which may provide incremental reimbursement above the MS-DRG to which the case is already assigned, for eligible case types and patients (e.g., Traditional Medicare patients).
May qualify for
New MS-DRGs
May qualify for new MS-DRG: 523, 524, 525
Cases involving Onyx may be assigned to MS-DRGs 523–525 through any of the following pathways:
- The procedure includes fusion of eight or more thoracic levels.
- The procedure includes fusion of at least two thoracic levels and at least two lumbar levels.
- The procedure includes iFuse Bedrock Granite® for SI joint fusion adjunctive to a multisegment spinal fusion and reported with one of the four Granite-specific ICD-10-PCS Section X codes.
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The lattice on Onyx is designed for immediate fixation and to osseointegrate over time, that combination is exactly what we've needed for improved durability of deformity constructs”
Jay Turner, MD, PhD
Neurosurgeon
Phoenix, AZOnyx incorporates our understanding of screw loosening into a novel implant designed to provide a meaningful option, especially for patients with poor bone quality.”
Brian A. O'Shaughnessy, MD
Neurosurgeon
Nashville, TNOnyx addresses fixation through an anatomy-specific thread design engineered for the unique demands of the vertebra.”
Han Jo Kim, MD
Spine Surgeon
New York, NYSI-BONE’s thoughtful approach to the design of this implant and rigorous testing of Onyx brings something really new to market for surgeons. This product in my opinion is truly a generational leap forward."
Zachary J. Tempel, MD
Neurosurgeon
Cincinnati, OHThe fenestrations provide a pathway for bone through-growth, which is an important part of achieving durable fixation.”
Gregory Mundis, MD
Orthopedic Spine Surgeon
La Jolla, CAEvents
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Healthcare professionals should refer to the Instructions For Use for indications, contraindications, warnings, and precautions at https://si-bone.com/label.
There are potential risks associated with iFuse procedures. They may not be appropriate for all patients and all patients may not benefit.
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