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The Smart Correction System is indicated for pediations (excluding newborns) and adults for the following: - · Joint contracture resulting in loss of range of motion. - · Fractures and disease which generally may result in joint contractures or loss of range of motion. - · Fractures requiring distraction. - · Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar). - · Correction of bony or soft tissue defects. - · Correction of bony or soft tissue deformities. - · Joint arthrodesis. - Infected fractures or nonunions. - · Limb Lengthening by epiphyseal or metaphyseal distraction. - · Pseudoarthrosis of long bones.

The WishBone Medical Smart Correction System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady, controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images, and the fixator parameters into the software. Post operatively, the surgeon enters the X-ray images and the current frame parameters into the software to establish an adjustment schedule for the patient during the healing process. The Smart Correction System is modular and facilitates a multitude of frame configurations to serve a wide variety of patient needs. Listed below are the high-level components and accessories: - The fixator bridge is constructed of two (2) or more ring components, and each ring component is connected to another via six (6) telescopic struts. Full, 2/3, and 1/3 ring components are available, along with standard and rapid adjust struts in multiple lengths. Threaded rods are used as needed to provide added frame stability. Rings are manufactured from aluminum material; struts from titanium, stainless steel, and aluminum; and threaded rods are made from stainless steel material. - The fixator bridge is anchored to the patient's bone by crossed tensioned wires and half pins that are secured to the rings by connector elements (wire clamps, pin clamps, cubes, bolts, nuts, and washers). Standard, olive wires, and threaded wires are available, as well as multiple diameters and styles of half pins. Pins and wires may also be used to secure fragments of bone and are made from stainless steel. Connector elements are manufactured out of titanium material. This submission also includes a line extension to add Hydroxyapatite (HA)-coated stainless steel Half Pin components. - A foot ring is available and connected to the distal ring when a procedure such as ankle arthrodesis is performed. The foot rings are manufactured out of aluminum material. - Patient comfort accessories are also included: strut ID clips (PETG), foot walking attachment (POM-C), and pin/wire caps (silicone, PVC) are also included. The Smart Correction System includes reusable surgical instruments to facilitate surgical assembly of the fixator construct. The non-sterile implants and other fixator elements are contained within sterilization cases, along with the reusable instruments.

The WishBone Medical Plate and Screw System is indicated for pediatric and adult patients of the clavice, scapula, humerus, ulna, radius, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus, and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. The system includes Femoral Locking Plates and Screws, which are in infant, child, and adolescent pediatric subgroups and small stature adult patients.

The WishBone Medical Femoral Locking Plate System was designed to address deformity correction in the proximal and distal femur where plating is an option for correction. It is intended to be used for temporary stable internal fixation of femoral osteotomies and fractures in pediatric patients. The system consists of two plate sizes, 3.5mm and 4.5mm, which align with the corresponding screw sizes, and are offered in varying lengths based on the quantity of screw holes needed. Plates have three screw holes in the "head" of each plate, plus 3, 4, 6, 8, or 10 screw holes in the shaft of the plates, based on plate configuration. Plates are also offered in varying angles ranging from 85° to 140°, with differing offsets and flares. These variations allow surgeons to best match the presenting patient's anatomy. New 3.5mm and 4.5mm locking and non-locking cortical screws are being added to the system for use with these new plates. The subject Femoral Locking Plate System implants are composed of 316- Stainless Steel material (ASTM F138-19) and are supplied in one of two single-use sterile packaging configurations based on plate size: sterile packed Tyvek-covered trays or Nylon pouches, each with a double sterile barrier. The Femoral Locking Plate System is a line extension of the WishBone Medical Plate and Screw System (K180736 & K213498).

The Smart Correction System is indicated for pediatric subpopulations (excluding newborns) and adults for the following: · Joint contracture resulting in loss of range of motion. · Fractures and disease which generally may result in joint contractures or loss of range of motion. · Fractures requiring distraction. · Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar). · Correction of bony or soft tissue defects. · Correction of bony or soft tissue deformities. · Joint arthrodesis. · Infected fractures or nonunion. · Limb Lengthening by epiphyseal or metaphyseal distraction. · Pseudoarthrosis of long bones.

The WishBone Medical Smart Correction System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process. The Smart Correction System is modular and facilitates a multitude of frame configurations to serve a wide variety of patient needs. Listed below are the high-level components and accessories: . The fixator bridge is constructed of two (2) or more ring components, and each ring component is connected to another via six (6) telescopic struts. Full, 2/3, and 1/3 ring components are available, along with standard and rapid adjust struts in multiple lengths. Femoral arches and threaded rods are used as needed to provide added frame stability. Rings and femoral arches are manufactured from aluminum material; struts from titanium, stainless steel, and aluminum; and threaded rods are made from titanium material. . The fixator bridge is anchored to the patient's bone by crossed tensioned wires and half pins that are secured to the rings by connector elements (wire clamps, pin clamps, cubes, bolts, nuts, washers, and twisted plates). Standard, olive wires, and threaded wires are available, as well as multiple diameters and styles of half pins. Pins and wires may also be used to secure fragments of bone and are made from stainless steel and titanium. Connector elements are manufactured out of titanium material. This submission also includes a line extension to add HA-coated titanium Half Pin components. . A foot ring is available and connected to the distal ring when a procedure such as ankle arthrodesis is performed. The foot rings are manufactured out of aluminum material. . Patient comfort accessories are also included: strut ID bands (polycarbonate), foot walking attachment (POM-C), and pin/wire caps (silicone, PVC) are also included. . The Smart Correction System includes reusable surgical instruments to facilitate surgical assembly of the fixator construct. The non-sterile implants and other fixator elements are contained within sterilization cases, along with the reusable instruments

The WishBone Medical Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum. femur. fibula. tibia. metatarsals and middle foot bones. and treatment of the calcaneus. Specifically, the Straight Fibula Plates are in infant, child, and adolescent pediatric subgroups and adult patients.

The WishBone Medical 7-Hole Straight Fibula Plate and WishBone Medical 3.0mm Cortical Screws and Locking Screws are wrought titanium alloy plate and screws (per ASTM F136) that are being added to the existing WishBone Medical Plate and Screw System as a line extension.

The WishBone Bone Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotion of deformity or arthrodesis. Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.

The purpose of this subject 510(k) is to introduce 4.0mm diameter cannulated screws and washers to the bone plate and screw system cleared under K180736.

The WishBone Medical Smart Correction® System is indicated for pediatric subpopulations (excluding newborns) and adults for the following: - · Joint contracture resulting in loss of range of motion - · Fractures and disease which generally may result in joint contractures or loss of range of motion - · Fractures requiring distraction - · Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar) - Correction of bony or soft tissue defects - · Correction of bony or soft tissue deformities - · Joint arthrodesis - Infected fractures or nonunions - Limb Lengthening by epiphyseal or metaphyseal distraction - · Pseudoarthrosis of long bones

The WishBone Medical Smart Correction System is a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process.

The WishBone Medical Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.

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The WishBone K-Wire System, is intended to be used for fixation of pediatric bone fractures, bone reconstruction; and guide pins for insertion of other implants.

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