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The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following: - Post traumatic and degenerative arthritis involving both ankle and subtalar joints, - Rheumatoid arthritis, - Osteoarthritis, - Pseudoarthrosis, - Severe foot/ankle deformity, or - Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.

The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials. The implants are intended for single use only and will be offered sterile and non-sterile.

The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.

The SBi Foot and Ankle Cannulated Screw System consists of screws and washers that provide fixation of small and long bones. The devices are supplied non-sterile and are available in various sizes and configurations. There are several lengths and diameters of the cannulated screws washers appropriate to the screw diameter. There are fully threaded and partially threaded (16mm and 32mm of thread) configurations. The system also includes guide wires and instruments for use in implanting the screws.

The SBi SR MTP Toe Implant is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and posttraumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.

The SBi SR MTP Toe Implant is a one-piece, stemmed device intended to replace the articulating surface of the metatarsal at the MTP joint. The implant is available in a range of sizes to match the geometry of the metatarsal head. Design features include an articulating surface which extends posteriorly on the superior side of the implant and a gently barbed stem to improve fixation in the metatarsal. The implants are made from wrought CoCrMo alloy (ASTM F1587) with a plasma coating comprised of commercially pure titanium (ASTM F1580).

The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi TwistoFIX System consists of a set of titanium bone screws for internal fixation. The screws are machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The devices are supplied non-sterile and are available in various sizes diameters and lengths.

The SBi ArtFIX is intended for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi ArtFIX System consists of compression screws that are used for internal fixation. ArtFIX is a cannulated, fully threaded, headless compression screw based on a conical design. The ArtFIX screw has a cutting tip and three thread configurations along its length.

The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi Titanium Threaded Pin consists of a set of titanium threaded pins for internal fixation. Each threaded pin has a machined groove that provides a "break-away" capability. The devices are supplied non-sterile and are available in various sizes diameters and lengths.

The SBi rHead Plating System is indicated for fractures of the proximal radius.

The SBi rHead Plating System consists of various plates and screws to treat fractures of the proximal radius. SBi plans to offer two plate designs: the rHead Neck Plate and the rHead Rim Plate. Both have a curved, T-shaped design to match the geometry of the proximal radius. Both will be available in a variety of neck widths, plate lengths, and hole geometries (threaded and non-threaded). Locking and non-locking screws will be included as part of the SBi rHead Plating System.

The SBi StaFIX is indicated for: . Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones. . Fixation of soft tissue to bone

The SBi StaFIX System consists of a set of stainless steel staples for internal fixation. The devices are supplied non-sterile and are available in several configurations and sizes.

The RingFIXTM System is intended for: 1. fracture fixation (open and closed) 2. pseudarthrosis or nonunions of long bones 3. limb lengthening by epiphyseal or metaphyseal distraction 4. correction of bony or soft tissue deformities 5. correction of segmental bony or soft tissue defects

This Special 510(k) Submission is intended to add additional components to the RingFIX™ System

The SBi Distal Radius Volar Plating System is intended for use in fixation of distal radial fractures. The implants are intended for one time use only

The SBi Distal Radius (DR) Plating System consists of plates and screws that provide internal fixation of the distal radius. The devices are supplied non-sterile and are available in various sizes and configurations. There are several plate configurations in right and left hand orientations. The System also includes an assortment of cortical and cancellous screws some of which can be locked into the plates at varying angles.