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510(k) Data Aggregation

    K Number
    K220142
    Device Name
    BRM Digitalis Spacer
    Manufacturer
    BRM Extremities Srl
    Date Cleared
    2023-04-04

    (441 days)

    Product Code
    KYJ
    Regulation Number
    888.3230
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRM Extremities Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by: - Osteoarthrosis; - Rheumatoid arthritis; - Post traumatic arthritis. The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by: - Rheumatoid arthritis; - Osteoarthritis; - Ankylosed joints or those with limited range of motion which have not responded to conservative treatment; - Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone; - Destroyed articular surface(s).
    Device Description
    The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.
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    K Number
    K222820
    Device Name
    BRM TOOL Screws, BIOPLAN Subtalar Implant
    Manufacturer
    BRM Extremities
    Date Cleared
    2022-12-16

    (88 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRM Extremities

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRM TOOL Screws The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. BIOPLAN Subtalar Implants The BIOPLAN Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - Flat foot treatment in children and adolescents - Congenital flat foot - Non successful long term orthopaedic treatment (shoes, insoles ...) - Tarsal coalitions - Painfully flat foot - Supple deformity in posterior tibial tendon dysfunction - Paralytic flat foot - Subtalar instabilitv
    Device Description
    The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy. The BIOPLAN Subtalar Implants are used for the correction of the flatfoot pathology. The BIOPLAN Subtalar Implants are available in Titanium alloy and PEEK options.
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    K Number
    K203773
    Device Name
    BRM TOOL Screws
    Manufacturer
    BRM Extremities Srl
    Date Cleared
    2022-01-14

    (387 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRM Extremities Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
    Device Description
    The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone, ligament, tendon or cartilage structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy.
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    K Number
    K191966
    Device Name
    NewPrim System
    Manufacturer
    BRM Extremities
    Date Cleared
    2020-02-13

    (205 days)

    Product Code
    KWH
    Regulation Number
    888.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRM Extremities

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRM Extremities NewPrim device is intended for use in: - Hallux rigidus or hallux limitus; - Painful rheumatoid arthritis; - Hallux abducto valgus associated with arthritis; - Unstable or painful joint from previous surgery
    Device Description
    The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
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