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The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices. The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I. The design features of the CrossCLIP™ Implant System are summarized below: - Implant Grade Nitinol (ASTM F2063-12) o - O Various sizes to accommodate patient anatomy - o One piece construction - Barbs to resist pull-out O - O Single use, sterile packaged instruments