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Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.

Versalock Upper Limb Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from titanium alloy or pure titanium. The plates range in thickness from 1.4 to 3.5 mm, and the screws range in diameter from 2.0 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Upper Limb Plating System are for single use and the devices are provided non-sterile. They must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Versalock Mini and Micro Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

GMReis Ankle Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle.

GMReis Ankle Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from titanium alloy. The plates range in thickness from 1.8 to 3.6 mm, and the screws range in diameter from 2.7 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. GMReis Ankle Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following: EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL: Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures. EXPERT ACL and EXPERT ACL II: Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair. EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC: Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE. The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.

The Versalock Rib and Sternum Plates System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, rib and sternum fractures, fusions and osteotomies.

The Versalock Rib and Sternum Plates System is indicated for the stabilization and rigid fixation of chest wall fractures, including sternal reconstruction processes, trauma and/or planned osteotomies. The physical principle is based on rigid fixation, where the screws have a specific thread profile in their head, which, when fixed, allows the surgeon to fix it with a variable angle of ±15° in the threaded hole of the plate. The system also allows fixation with non-threaded head screws when the surgeon so desires. The devices are presented in Titanium Alloy according to the standard ASTM F136 and Pure Titanium According to ASTM F67.

Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.

Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition. The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.

Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.

The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision. The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.

The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including: - · Periprosthetic fractures - Comminuted fractures - Supracondylar fractures - Trochanteric fractures - · Fractures in normal and osteopenic bone - Non-unions and Malunions.

The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device. The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates. The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface. The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.

The EXPERT - Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following: Mini EXPERT When used for fixation of bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as: - Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions; - Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and - Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the ligament at the base of the thumb metacarpal by providing stabilization between the first and second metacarpal when the trapezium has been excised due to osteoarthritis. EXPERT Knotless and EXPERT Knotless Dual Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The EXPERT – Joint Fixation System is available in three models. Each model is composed of different medical devices (i.e. plates, surgical suture) assembled together for the purpose of use as a set. Each set is composed of plates from different sizes and shapes made of Titanium Alloy (ASTM F136) associated with non-absorbable surgical sutures and/or surgical meshes made of an Ultra-High Molecular Weight Polyethylene (UHMWPE). The metallic components are manufactured by GM dos Reis Indústria e Comércio Ltda and the nonabsorbable Surgical Sutures and Surgical Suture Meshes are purchased in bulk from River Point Medical (K100006). Each EXPERT model comes with a transient use guidewire accessory in the same package. The guidewire is made of Stainless Steel (ASTM F138) to aid in the EXPERT - Joint Fixation System placement. In order to promote a correct placement of EXPERT – Joint Fixation System, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drill bits, drill guides, plier, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the subject devices and promote the success of the procedure.