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The HD LifeSciences Hive^TM Stand-alone Anterior Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as stand-alone interbody devices. If the accompanying screws are not used the device is intended for use with supplemental fixation. Hyperlordotic implants (20° and greater lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine.

The Hive™ Lumbar Interbody Fusion System is FDA cleared under K170676. This submission describes an addition to the Anterior IBFD configurations in which the device in combination with the provided screws would serve as a stand-alone interbody fusion device. This submission adds the Hive™ Stand-alone Anterior Lumbar Interbody System to the previously cleared system, which consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium conforming to ASTM F3001 using additive manufacturing technology. The implants of the Hive™ Stand-alone Anterior Lumbar Interbody System are offered in a variety of lengths, widths and cross-sectional geometries to accommodate patient anatomy and surgical approach. The implants of the Hive™ Stand-alone Anterior Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. Implants incorporate features for fixating the device to the vertebral body in a modular stand-alone manner using either interfixated features within the intervertebral space or outer plate fixation on the anterior surface of the vertebral bodies. Inter-fixation and outerfixation allow adjustable placement of fixation components utilizing screws and screw cover plates made from Ti-6A1-4V conforming to ASTM F136.

The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of nonoperative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.

The HD LifeSciences Cervical IBFD System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation.

The HD Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone.

The HD Lumbar Interbody System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The implants of the HD Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the HD Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided sterile.