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510(k) Data Aggregation

    K Number
    K250498
    Device Name
    BPS Wrist Fracture System
    Manufacturer
    Date Cleared
    2025-03-17

    (25 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoNovis, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
    Device Description
    The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fractures several sizes of distal radius plates as well as various styles of locking, non-locking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136.
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    K Number
    K250055
    Device Name
    BPS - Bone Fragment Fixation Plates, Screws and Washers
    Manufacturer
    Date Cleared
    2025-02-06

    (27 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoNovis, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OrthoNovis bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
    Device Description
    The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia,phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates s are a one-piece device made of commercially pure titanium alloy or stainless steel.
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    K Number
    K242343
    Device Name
    BPS Wrist Fracture System
    Manufacturer
    Date Cleared
    2024-10-04

    (58 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoNovis, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
    Device Description
    The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fracture System features several sizes of distal radius plates as well as various styles and sizes of locking, nonlocking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6AI-4V ELI) per ASTM F136.
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    K Number
    K213905
    Device Name
    ONX Large External Fixation System
    Manufacturer
    Date Cleared
    2022-08-25

    (254 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoNovis, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ONX Large External Fixation System is indicated for the following: - Stabilization/fixation of: - Long bone fractures in tibia and femur - Fractures of pelvis and ankle - Peri-articular and intra-articular fractures of knee and ankle - Joint arthrodesis - Non-unions and mal-unions - Osteotomies
    Device Description
    The ONX Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins, components, and posts are made from materials conforming to ASTM F136 and ASTM F138.
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