Profile: OrthoHelix Surgical Designs, Inc. is an orthopedic medical device company developing a comprehensive line of implants and instruments for use in foot/ankle and hand/wrist reconstructive surgery. Our hand product includes DR lock system. Our DR lock system is a series of implantable bone fixation plates, pegs and screws. Its intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius. The system includes plates for both the left and right wrist in three different size lengths such as short, standard, and long. The plates of the system are anatomically designed to provide an improved fit to the volar surface of the radius. This design decreases the possibility of misplacement during surgery. It allows surgeons for multi-planar fixation, which provides increased stability. Our foot product includes maxlock extreme, max torque system, calc lock system, maxlock system and ortho lock. Our ortholock is a locking plate & screw technology for foot and ankle surgery.
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• Bone Fixation Plate (FDA Code: HRS / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• Bone Fixation Screw (FDA Code: HWC / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• Custom Depth Gauges |
• Drill Bit (FDA Code: HTW / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
• Drill Guides |
• Implantable Bone Fixation Plates |
• Nut Bolt Washer (FDA Code: HTN / 888.3030) |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |