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510(k) Data Aggregation

    K Number
    K242988
    Device Name
    Genostis Osteosynthesis System
    Manufacturer
    Genostis AF
    Date Cleared
    2025-06-27

    (274 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
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    Applicant Name (Manufacturer) :

    Genostis AF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions. One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand. Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius) Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required. The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures. The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius. One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula. Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia. The Clavicle Superior Plates 3.5 are indicated for: - Fractures of the clavicle shaft - Fractures of the lateral clavicle - Malunions of the clavicle - Non-unions of the clavicle The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus. The Tibia Proximal Lateral Plates 3.5 are indicated for: - Split-type fractures of the lateral tibial plateau - Lateral split fractures with associated depressions - Pure central depression fractures - Split or depression fractures of the medial plateau The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia. The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia. The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for - Intraarticular fractures of the distal humerus - Supracondylar fractures of the distal humerus - Non-unions of the distal humerus The Humerus Distal Medial Plates 2.7/3.5 are indicated for - Intraarticular fractures of the distal humerus - Supracondylar fractures of the distal humerus - Non-unions of the distal humerus The Ulna Proximal Olecranon Plates 3.5 are indicated for - Complex extra- and intra-articular olecranon fractures - Non-unions of the proximal ulna - Osteotomies - Simple olecranon fractures Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia. Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia. Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia. T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.
    Device Description
    The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking). All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3. The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.
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