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The Signature Osteosynthesis Plate System is intended for adult patients for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions. The 1/3 Tubular Plate and Compression Plate Small are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the Foot, hand, wrist, and forearm. Additionally, the Compression Plate Narrow and Compression Plate Broad are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the upper extremity and lower extremity, except for the femur and proximal tibia. The Clavicle Plates are intended for use in fixation of fractures, osteotomies, and non-unions of the clavicle in adult patients in whom the clavicular growth plates have fused or in whom the growth plates can be crossed by the plate system.

The Signature Osteosynthesis Plate System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The System utilizes medical grade Titanium alloy. System implants are provided both sterile and non-sterile with instructions for steam sterilization. The sterile implants are provided sterilized in Tyvek packaging. The implants are single use only.

Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures. It is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, when reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT or 2D/3D C-arm images of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and lumbosacral spine. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. The Headset of the Caduceus S displays 2D stereotaxic screens and a 3D anatomy model (floating). The displayed stereotaxic screens are indicated for correlating the tracked instrument location to the patient registered imagery to assist in percutaneous visualization and trajectory planning.

The Caduceus S system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Navigation Cart, Navi Tracker, Headset, Minimally Invasive Spine Surgery Instruments, Disposable Passive Spheres, and other disposable surgical consumables. It uses optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' eyes using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

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 Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The Magnes-C™ Anterior Cervical Plate System components are intended for anterior screw fixation and stabilization of the cervical spine during the development of cervical interbody spinal fusion. The Magnes-C™ Anterior Cervical Plate System consists of one through three-level plates and fixed and variable screws, in a variety of sizes to accommodate individual patient anatomy. The Magnes-C components are provided nonsterile. Instruments to facilitate unilateral anterior fixation are included.

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.

Caduceus S is intended as an intraoperative gudance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data. Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm). The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

Caduceus S surgical navigation system is an image guidance system, which is composed of Navi Tracker, Surglasses, other hardware (Navigation Cart with an arm, Touch Screen, Router, Control System, Connection System), disposable tools (Disposable Passive Sphere, Straight Guide Pin, Navi Clamp Kit, Instrument Adapter Type A&B, Calibration Plate, Registration Kit, Correction Tool), reusable tools (Calibration Board, Instrument Holder), and Spine Navigation Software. Caduceus S is an optical tracking and guiding system for spine surgery. It can track the marks on the surgical instruments and patient's anatomical structure with marks, and register with the preoperative or intraoperative images of the patients. During the surgery, it can be displayed on the Touch Screen and the head mounted display Surglasses to provide the navigation for the surgical instruments.

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.