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510(k) Data Aggregation

    K Number
    K002325
    Device Name
    WUJIN #3 TIBIAL NAIL
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    2000-10-30

    (90 days)

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

    BIOLOGICALLY ORIENTED PROSTHESES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992144
    Device Name
    BIOPRO RIMMED ACETABULAR COMPOMENT
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    1999-09-22

    (90 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLOGICALLY ORIENTED PROSTHESES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Osteoarthritis 2. Rheumatoid arthritis with severe hip pain and limited joint motion. 3. Avascular necrosis 4. Traumatic arthritis 5. Acetabular cavity deformities caused by congenital problems. 6. Revisional surgery after one or more total hip operations. 7. Fixation with bone cement and/or cancellous bone screws.
    Device Description
    The rimmed acetabular component is manufactured of Titanium 6 A1-4V Bli (ASTM F136). It is available in five sizes: 54mm, 58mm, 64mm, 70mm, and 76mm. The BioPro rimmed acetabular component accommodates BioPro's 28nun and 32mm Cox Comb inserts: 28x55 (10068), 28x58 (10069), 28x65 (10071), 28x69 (10074), 28x75 (11227), 32x55 (10077), 32x58 (10078), 32x65 (10081), 32x69 (10083), and 32x75 (10084).
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    K Number
    K964472
    Device Name
    RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    1997-02-03

    (88 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLOGICALLY ORIENTED PROSTHESES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb with limited range of motion.
    Device Description
    The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anatomically configured tri-flanged stem that fits into the medullary canal at the proximal end of the first metacarpal. This tri-flanged configuration allows for compaction of bone around the implant to provide stable fixation and to prevent rotation of the device. The head is spherical and extends just beyond a hemisphere, slightly medialized on the stem and is at a 20° varus angle to the stem to properly space the joint and allow for sufficient range of motion. The trapezium is resurfaced to contain the head of the implant and this resurfacing is continued into the second metacarpal. Resurfacing the second metacarpal prevents impingement of the implant against that bone and decreases the possibility of dislocation of the joint.
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    K Number
    K962769
    Device Name
    HORIZON HIP SYSTEM
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    1996-10-03

    (79 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLOGICALLY ORIENTED PROSTHESES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Both systems are indicated for treatment of osteoarthritis, rheumatoid arthritis, avascular necrosis, and traumatic arthritis. Contraindications include: excessive bone loss, septic arthritis, periarticular osteomyelitis, and local or systemic infection.
    Device Description
    proprietary name: Horizon Hip System common name: prosthetic. Total Hip System classification name: prosthetic, Total Hip System Femoral component: The Horizon Femoral Stem is manufactured from cobalt chrome and features a collar to distribute stress in a physiological manner. It is available with or without porous coating. The femoral component is available in five sizes: 12mm, 15mm, 16,5mm, and 18mm. Acetabular Insert: The Horizon Acetabular Insert is manufactured of UHMWPE. It is designed to snap fit into the acetabular shell. The insert will accept 28mm heads. It is offered in sizes ranging from 46mm to 60mm. Acetabular Shell (cup): The Horizon Acetabular Shell is manufactured of cobalt chrome. It features three spikes to prevent rotation. It also features a groove on its I.D. to accept the mating acetabular insert. The acetabular shell is porous coated to promote long term fixation. The acetabular shell is available in eight sizes: 46mm, 48mm, 52mm, 52mm, 56mm, 56mm, and 60mm.
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    K Number
    K955916
    Device Name
    TOWNLEY TOTAL ELBOW SYSTEM
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    1996-08-08

    (223 days)

    Product Code
    JDC
    Regulation Number
    888.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLOGICALLY ORIENTED PROSTHESES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required. Indications: Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.
    Device Description
    Humeral Component: The humeral component of the Townley Total Elbow is manufactured of Cobalt Chrome (ASTM F-799). It is offered in both right and left designs and features a stabilizing intramedullary stem that is angled in five degrees of valgus to accommodate the normal carrying angle of the elbow. The proximal, bone-interfacing, non-articulating side of the body is designed with a squared receptical to accept the similarly remodeled humeral condyles. The articulating surface of the humeral component is contoured to allow a snap-fit with the ulnar component and is extended laterally to articulate with the radial head. It is offered in three sizes: 35mm, 40mm, and 45mm. Ulnar Insert: The ulnar insert is manufactured of UHMWPE. The insert is designed to snap onto the humeral component and provide a stable joint while retaining multiplanar flexibility. It is offered in two sizes: small and large. Ulnar Tray: The ulnar tray is manufactured of Cobalt Chrome (ASTM F-799). It features a L-shaped body which provides support for the polyethylene insert as well as a stem that aids in fixation. It is offered in two sizes: small and large.
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    K Number
    K954768
    Device Name
    BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    1996-01-18

    (93 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLOGICALLY ORIENTED PROSTHESES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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