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M6-C™ Artificial Cervical Disc Surgical Instruments
Care and Handling Instructions
DEVICE DESCRIPTION
The surgical implantation of the M6-C Artificial Cervical Disc requires specific surgical instruments including: a
footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create
tracks in the superior and inferior vertebral endplates; and an implant inserter to place the disc into the desired
position to aid in and ensure correct placement within the intervertebral space. Additionally, there is a tamp to
independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the
disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The
instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion
resistance, with some instrument handles also featuring aluminum and Radel materials. Surgical instruments
are provided non-sterile and are intended to be reusable.
The instruments provided in the kit include Footprint Templates, Trials, Inserters, Fin Cutters, a Tamp, Removal
Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer
Pins and Locking Nuts. All instruments are made of surgical stainless steels per ASTM F899-12b, aluminum
(mallet handle), and Radel (pin driver handle).
The M6-C Instrument Tray is composed of stainless steel, Nylon, Radel Plastic, and Silicone. The tray is multi-
layered with various inserts to hold surgical instrumentation in place during handling and storage. The
instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur
in a steam autoclave.
