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The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System. The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

The SALGINA 2.5mm Distal Radius System is indicated for - · Intra-articular fractures of the Distal Radius. - · Extra-articular fractures of the Distal Radius The CASCELLA 3.5mm Superior Clavicle System is indicated for: - fixation of fractures of the clavicle shaft - fixation of fractures of the lateral clavicle - malunions of the clavicle - · non-unions of the clavicle The LEPORELLO 3.5mm Olecranon System is indicated for - · fractures - osteotomies - nonunions of the olecranon and proximal ulna.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899. ISO 7153-1. ISO 5832-1. and ASTM F138/139). medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.

The Bonebridge POYA 3.5mm Posteromedial Tibia System is intended for adult patients and indicated for internal fixation of posteromedial proximal tibia fractures, including buttressing of fractures of the proximal and metaphyseal areas of the tibia. Additionally, the longer plates are indicated for fractures extending to the tibial shaft. The POYA 3.5mm Medial Proximal Tibia System is intended for adult patients and indicated to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia. The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically, - the Medial and Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia. - . The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia. - . The Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone, All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.

The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.

TAMINA 3.5mm Proximal Humerus System The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for · Dislocated two-, three-, and four fragment fractures of the proximal humerus including osteopenic bone - · Pseudarthroses (non-unions) of the proximal humerus - · Osteotomies of the proximal humerus POYA 3.5mm Lateral Proximal Tibia System The POYA 3.5mm Lateral Proximal Tibia System is internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including: - · simple fractures - · comminuted fractures - · lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures - · depression fractures - · periprosthetic fractures - · nonunions, malunions, tibial osteotomies and osteopenic bone - · fractures with associated shaft fractures LORRAINE 3.5mm Distal Humerus System The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surqical use. Non-clinical testing has demonstrated the devices are MR Conditional.

The SALGINA® 2.5mm Volar Distal Radius System is indicated for - · Intra-articular fractures of the Distal Radius - · Extra-articular fractures of the Distal Radius The CASCELLA® 3.5mm Superior Clavicle System is indicated for: - fixation of fractures of the clavicle shaft - · fixation of fractures of the lateral clavicle - malunions of the clavicle - · non-unions of the clavicle The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for: · Dislocated two-, three-, and four fractures of the proximal humerus including fractures involving osteopenic bone. - · Pseudarthroses (non-unions) of the proximal humerus - · Osteotomies of the proximal humerus The POYA® 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including: - simple fractures - · comminuted fractures - · lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures - · depression fractures - · periprosthetic fractures - · nonunions, malunions, tibial osteotomies and osteopenic bone The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia. The DALVAZZA® 2.5mm Distal Ulna System is indicated for - · fixation of fractures - nonunions of the distal ulna. The LEPORELLO® 3.5mm Olecranon System is indicated for - fractures - · osteotomies - non-unions of the olecranon and proximal ulna.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F899), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surqical use. Non-clinical testing has demonstrated the devices are MR Conditional.

The TRIFT 3.5mm 1/3 Tubular Plate is indicated for: • Treatment of smaller fractures of long bones such as humerus, fibula, and ulna

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates and non-locking screws for fixation and corresponding instruments. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F899), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use.