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The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of: - Open and closed fractures - Osteotomies - Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction - Pseudoarthrosis, infected union, non-union, or malunion of long bones - Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction - Correction of bony or soft tissue deformity (orthoplastic surgery) - Joint arthrodesis - Infected fractures - Correction of segmental bony or soft tissue defects - Management of comminuted intra-articular fractures - Bone transport - Revision procedures where other treatments or devices have been unsuccessful - Bone reconstruction procedures - Charcot foot reconstruction - Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle - Ankle distraction (arthrodiastasis) - Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. HA coated half pins and tensioned wires are then used to fixate and stabilize bones and joints. Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods, threaded pillars, rancho cube pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and HA coated half pins, manufactured from stainless steel, available in multiple diameters and lengths. HA coated half pins are provided sterile packed while all other system components are provided non-sterile. All External Fixation components are for single use only.

The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications: - · Stabilization of Fractures & Osteotomy - · Rear and Mid-foot Foot Arthrodesis - · Adult and Pediatric (greater than 2 through 21 years of age) Leg Lengthening - · Correction of Bone Deformity in Upper & Lower Extremities The P&C Software is intended to be used as a component of multilateral external fixations listed above.

The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires, and half pins are attached to the bone and to the frame itself. The components included in the external fixation system are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are nonpyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated. The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The use of software is optional and is utilized with the bridging and additional necessary hardware elements of the frame.

The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of: Open and closed fractures Osteotomies Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis, infected union, non-union, or malunion of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity (orthoplastic surgery) Joint arthrodesis Infected fractures Correction of segmental bony or soft tissue defects Management of comminuted intra-articular fractures Bone transport Revision procedures where other treatments or devices have been unsuccessful Bone reconstruction procedures Charcot foot reconstruction Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle Ankle distraction (arthrodiastasis) Septic fusion

The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. Pins and tensioned wires are then used to fixate and stabilize bones and joints. Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods and threaded pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and half pins, manufactured from stainless steel, available in multiple diameters and lengths. All External Fixation components are for single use only.

TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment. The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients. The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits). The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone. The positioning of the half pins is driven by a template. During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment. The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

The Monkey Bars Pin to Bar External Fixation System is intended to be used in adult and pediatric patients (specifically, children and adolescents aged 2 through 21 years) 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 by 150mm to 500mm lengths, titanium combination clamp, aluminum 5 & 8 hole multi-pin clamps, aluminum straight and 30 degree angled posts, stainless steel 3mm, 4mm and 5mm thread diameter pins with 5mm diameter shanks that come in blunt tip and self tapping with 125mm through 230mm overall lengths and 20mm through 65mm thread lengths, stainless steel transfixing pin with 5mm shank, 7.2mm thread diameter, and 325mm overall length, and 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 Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.

The Response Ortho Metaphyseal Hinge Fixator System is a unilateral fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The system is designed to provide low profile and comprehensive solution invasively. Implants, reusable instruments, accessories, case&tray are included in the system. Products are non-sterile and implants that exist in the set, are single use. Instruments that are in the system, can be used repeatedly after cleaning and sterilization.

The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones: - Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures - Fusions of the joints and bone (hand, foot, long-bone) - Correction of bone or soft tissue deformities - Correction of segmental or non-segmental bone, soft tissue defects or bone loss - Neutralization of fractures stabilized with limited internal fixation - Adult and Pediatric subgroups except newborns

The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

The LINK™ External Fixator is indicated for 1) hand and foot bone fragment and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

The LINK™ External Fixator is a single use External Fixator consisting of a stainless steel flat spring formed into a box shape so that when released it applies forces and moments to Bone Pins, K-wires or Steinmann pins embedded in bone to actively pull together and compress or distract bone. In clinical use the LINK™ External Fixator is held with its holes aligned using surqical needle drivers while wires or pins are advanced through the LINK™ External Fixator, skin and into bone. Once pins are placed the needle drivers are released, the LINK™ External Fixator bridge shortens to apply forces and the LINK™'s side elements swing outward to create moments on the wires or pins. The LINK™ External Fixator uses spring heat treated 17-7 stainless steel which is uniquely formed from a flat plate to create a shape changing spring. The Bone Pins in this kit are formed with 316 Stainless Steel. The LINK™ External Fixator has a separate removable silicon elastomer cover to protect the LINK™ External Fixator and the patient from the pin ends. Only the Bone Pins are in contact with the patient while the LINK™ External Fixator and its cover are external to the body and not intended for patient contact.

The Hoffmann LRF System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults. The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: - Open and Closed Fractures - Post-traumatic joint contracture which has resulted in loss of range of motion - . Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction - Pseudoarthrosis or non-union of long bones - Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction • - . Correction of bony or soft tissue deformity - . Correction of segmental bony or soft tissue defects - . Joint arthrodesis - . Management of comminuted intra-articular fractures of the distal radius - . Bone transport The Hoffmann LRF System is indicated in adults for: - Osteotomy - . Revision procedure where other treatments or devices have been unsuccessful - . Bone reconstruction procedures - . Fusions and replantations of the foot - Charcot foot reconstruction - . Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from stainless steel, aluminum, PEEK, and carbon fiber. Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates). Specific indications, which are dependent on the angle of the plate, include: 130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric. 95°: distal and intercondylar fractures of the femur.

The Auxein's DHS/DCS Plate System offers a variety of treatment options depending on the fracture site and the patient. The DHS/DCS Plate System is composed of plates, compression screw and bone screws. The devices are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1. These implants will be available either in sterile or non-sterile state. Note- Non sterile products have to be sterilized before use. The system is indicated for use in skeletally mature patients only. All implants are for single use only.