The Optio-C Plate is a component of the Optio-C
Anterior Cervical System and intended to be used only in anterior
surgical procedures. The Optio-C Plate must be used with three
Optio-C bone screws and is designed to be used with either one
of the following:
- one Optio-C Anterior Cervical PEEK Intervertebral Body
Fusion (IBF) Spacer or
- one Optio-C structural
allograft or
- one structural allograft/autograft of
the same height
The Optio-C Plate and PEEK IBF Spacer are supplied sterile to
the end user. The bone screws and instrumentation are supplied
non-sterile and are intended to be sterilized by the end user. This
IFU is specific to the Optio-C Plate.
The Optio-C Plate is offered in a one-level configuration,
with a standard width and multiple heights and is designed to
facilitate fusion. The plate with Optio-C PEEK (IBF) Spacer or
a structural allograft/autograft is placed in the cervical disc space,
flush with the adjacent vertebral bodies. Bone screws pass through the
screw holes of the plate and affix to bone to help prevent implant
migration. The implant construct can be implanted in two orientations:
Standard orientation, two screws cephalic and one screw caudal or
Inverted orientation, one screw cephalic and two screws caudal.
The bone screws are offered in a variable-angle design and have a
cortical/cancellous thread design. Bone screws are available with both
self-drilling and self-tapping tip designs and are available in
multiple lengths.
Multiple instruments include, but are not limited to, trials, rasps,
and inserters that facilitate the insertion and removal of the
Optio-C implants. Refer to the surgical technique guides for a
complete listing and description of all Optio-C instrumentation
and detailed instructions for use.