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The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ Implant System with the exception of the 2-hole plate may be used with the MotoCLIP™ HiMAX™ Implant System.

The subject MotoBAND CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries are 5° valgus and have options of 0°,5°, and 10° dorsiflexion and can be used with 18mm, 20mm or 25mm nitinol clip. Non-locking and poly-axial locking screws are included in the system: 3.0mm diameter and 3.5mm diameters in lengths of 10-50 mm. MotoBAND CP Implant System is compatible with MotoCLIP/HiMAX Clips.

The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

The CrossRoads Screw System was previously cleared under 510(k)s K143039 & K152072 and is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy. The screws that are the subject of this submission incorporate design modifications and additional lengths to the 2.0mm, 2.5mm, and 3.0mm screws as well as the addition of new 2.0mm, 4.0mm and 7.0mm Headless Screws. The design modifications include screw thread changes, screw head/driver interface changes, and the addition of reverse cutting threads.

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

The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstructive surgery. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.