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The TiDAL Osteotomy Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as: - Cotton (opening wedge) osteotomies of the medial cuneiform - Evans lengthening osteotomies. The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation. The TiDAL Osteotomy Wedges are not intended for use in the spine.

The proposed ADI TiDAL Osteotomy Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights. The ADI TiDAL Osteotomy Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as Cotton (opening) osteotomies of the medical cuneiform and Evans (lengthening) osteotomies. The TiDAL Wedge device is comprised of a single, continuous piece of titanium alloy fabricated via additive manufacturing. The ADI device has a porous structure throughout the body of the implant and a circular window for the packing of graft material, a threaded hole for insertion (Evans implant only), and a strike plate for implant positioning.

The restor3d Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in sketally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The proposed ADI Cervical Interbody Fusion Device is a sterile, single use implant grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant is intended to be used with cleared fixation devices such as an anterior cervical plate system. The ADI device is comprised of a single, continuous piece of titanium alloy fabricated via additive manufacturing. The ADI device has a porous structure throughout the body of the implant, a circular window for the packing of graft material, a threaded hole for insertion, teeth on the surfaces of the perimeters to aid expulsion resistance, and side windows on the walls of the implant.