The Optio-C System is the industry's first no profile, modular stand-alone cervical device that offers allograft* and PEEK options and delivers the strength, stability and fusion potential of a traditional ACDF.
REDUCES soft tissue irritation for less invasive ACDF procedures
ELIMINATES the need for additional plating when addressing adjacent level disease
STRENGTH: Plate equivalent to a traditional cervical plate1
STABILITY: Three screw fixation is designed to reduce segmental motion and interference with existing hardware
FUSION: Spacer features a load-sharing interface designed to reduce stress shielding
1 Demonstrated by mechanical testing per ASTM F1717. Data on file at Zimmer Spine.
2 Comparison of Self-Drilling and Self-Tapping Cervical Spine Screws Using ASTM F543-07.Journal of ASTM International, Vol. I, No 7, July 2011.
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:
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.
When Optio-C Anterior Cervical Plate is used with structural allograft/autograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft/autograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograft/autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with structural allograft/autograft and with three Optio-C bone screws.
When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.
The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
See also the WARNINGS, PRECAUTIONS and POSSIBLE ADVERSE EFFECTS section.
It is strongly recommended that the patient be informed of the risks associated with surgical procedures and components:
Complications and adverse reactions have been reported with the use of similar spinal instrumentation systems. These adverse effects, including the possibility of death, should be discussed with the patient prior to surgery.
Possible neurologic operative/postoperative adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:
Possible device postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:
Possible general or local postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include: