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The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67. The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.

The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device. The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)

The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

The OIC Intramedullary Screw System consists of stainless steel screws and instruments to facilitate implantation. The screws come in two diameters, 3.6mm and 4.5mm, and range in length from 25mm to 80mm. The system also includes the instruments used to implant the screws. The OIC Intramedullary Screw System is provided non-sterilized by the medical facility prior to implantation. The screws are manufactured material that conforms to: ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Variable Angle Small Fragment Locking Plate System consists of titanium plates for the Distal Radius, Clavicle, Proximal Humerus, Tibia, Distal Fibula, a Low Profile 1/3 Tubular and Hook plate, bone screws and instruments for implantation. The plates come in a variety of sizes and accept 2.5mm, 3.5mm and 4.0mm bone screws. The bone screws are available in two diameters of cortex screws (2.5mm and a 4.0mm cancellous screw. They range in length from 6mm to 130mm. The cortex screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Variable Angle Small Fragment Locking Plate System is made of titanium alloy in compliance with ASTM F136, ASTM F1472 or ASTM F67. The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.

The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, a dorsal spanning plate, bone pegs, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are pre-contoured to match the anatomy of the distal radius. They accept 2.0mm locking pegs, 2.3mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates. The dorsal spanning plate is being added to the system in this submission.

The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, bone peos, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are precontoured to match the anatomy of the distal radius. They accept 2.0mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws. The bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates.

The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths Titanium and aluminum combination clamp, 5 & 8 hole pin clamp Aluminum straight and angled posts Stainless steel 3mm, 4mm and 5mm pins, blunt tip and threaded 85mm through 250mm lengths, 10mm through 120mm thread lengths. Stainless steel 5mm transfixing pin, 300mm length Stainless steel instruments for implantation The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths Titanium and aluminum combination clamp, 5 & 8 hole pin clamp Aluminum straight and angled posts Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths. Stainless steel 5mm transfixing pin, 300mm length Stainless steel instruments for implantation The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.

The OIC Suture Anchor System consists of anchors and instruments to aid in implantation. The anchors are a screwlike device manufactured from PEEK plastic which are implanted into bone. Each anchor is 15mm in diameter and has an eyelet at the top that is used as an attachment point for sutures are used to fasten soft tissues to facilitate healing. Sutures are not included in the system. Instruments include an anchor driver, 5.5mm punch/tap, suture threader and tray. The instruments are made from stainless steel and aluminum.

The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nay be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.

The OIC Intramedullary Nail System consists of the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lad screws are 10.5mm in diameter and range in length from 70mm to 120mm. The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI. The additional instruments being added to the OIC Intramedullary Nail System are provided in the non-sterile condition. They are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle.