Lateral Lumbar Interbody Fusion is an approach to spinal fusion in which the surgeon accesses the intervertebral disc space using a surgical approach from the patient’s side (lateral) rather than from the front (anterior) or the back (posterior). The lateral approach provides an alternate route to the spine that disturbs fewer structures and tissues. Lateral Lumbar Interbody Fusion is an option that a surgeon may use to treat patients with lumbar degenerative disc disease (DDD). The Skyhawk® Lateral Interbody Fusion System and Skyhawk Lateral Plate System provide a complete solution for the surgeon to perform a Lateral Lumbar Interbody Fusion (L2-L5).
Comprehensive discectomy and annulotomy instruments including rongeurs, disc cutters, box chisels, curettes, cobbs, and rasps
Neuromonitoring pack and fiberoptic light source available
Fluoroscopic targeting crosshair aids in localizing the disc space and targeting the incision
SKYHAWK Interbody spacers are available in heights ranging from 6mm to 20mm, widths of 16mm, 18mm, 22mm and 26mm, lengths of 35mm, 40mm, 45mm, 50mm, 55mm and 60mm and lordosis of 0˚, 8˚ and 12˚.
Lateral interbody spacers are composed of PEEK with tantalum markers located at both ends and the middle of the implant for clear fluoroscopic visualization
Large graft window for packing bone grafting material
SKYHAWK Lateral Plate:
Low profile lateral plate – set screws locks flush within the plate
Plate sizes coordinate with Interbody heights
Lateral plates and bone screws are manufactured from titanium alloy
Lateral plates are available in sizes 6, 8, 10, 12, 14, 16, and 20
Bone screws area available in lengths of 30mm, 35mm, 40mm, 45mm, 50mm, 55mm and 60mm
QUADRx™ Lateral Retractor:
Implements a straightforward 4 blade design
Ergonomic rectangular aperture opening provides adaptability to both patient anatomy and surgeon technique
Innovative blade design requires no sequential dilation prior to retractor placement over the guide wire
The SKYHAWK Lateral Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The SKYHAWK Lateral Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the SKYHAWK Lateral Interbody Fusion System.
The SKYHAWK Lateral Interbody Fusion System, as with other orthopedic implants, is contraindicated for use in patients:
With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection
With rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation
With conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
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