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The Hive™ Standalone Cervical System, including devices with a microscopic roughened surface and micro and nano-scale features, is indicated at one or more levels of the cervical spine (C2-T1) in skeletally mature patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous, cortical, and/or corticocancellous bone.

The Hive™ Standalone Cervical System is intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When used with anchors, or without two screws, these devices are intended to be used with supplemental fixation (e.g. cervical plates or cervical posterior fixation).

The Hive™ C Interbody System, including devices with a microscopic roughened surface and micro and nano-scale features, is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with an interbody fusion device. The Hive™ C Interbody System is indicated to be used with autograft bone and/or allograft bone comprised of cancellous, cortical, and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion (hereafter referred to as bone graft). The Hive™ C Interbody System requires additional supplemental fixation cleared for use in the cervical spine.

The Hive™ Standalone Cervical System consists of additively manufactured interbody fusion cages made from Ti-6Al-4V per ASTM F3001 and screws, plates, and anchors made from Ti-6Al-4V per ASTM F136. The cages, bone screws, and plates were originally cleared via K223190. The purpose of this submission is to add bone anchors as an additional form of internal fixation and include an additional packaging configuration option. The implant components of the Hive™ Standalone Cervical System are offered in a variety of sizes to accommodate patient anatomy and surgical approach. The cage implants are provided sterile while the bone screws and anchors are provided non-sterile.

The Hive™ C Interbody System consists of interbody fusion cages additively manufactured from Ti-6Al-4V ELI per ASTM F001. The interbody cages have a microscopic-roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The Hive™ C Interbody System implants are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants are provided sterile. The purpose of this submission is to modify the indications for use and packaging from the previously cleared system.

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