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510(k) Data Aggregation

    K Number
    K962215
    Device Name
    CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-08-15

    (66 days)

    Product Code
    HWE
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.
    Device Description
    A template is placed on the distal femur. This template is made from stainless steel (17-4PH SS @ H900). The template contains a central groove with adequate markings that ensure proper guidance of the router. The router itself consists of a router bit (17-4PH SS @ H900), the shank of which is encased in a plastic body (Ultem® 4000) that acts as a handle for the surgeon and as a journal bearing for the shaft of the router bit. The base of the body has a large diametrical flange that rests on the superior surface of the template. This flange acts to stabilize the router against torsional forces created by the router bit. The superior end of the router shank is attached to a standard flexible shaft. A standard Zimmer fitting is integrally machined to the superior side of the flexible shaft in order to accommodate a standard operating room power drill (Stryker, 3M, etc.). The router body and bit are available in one size. The template is available in three sizes; size 1/2, size 3/4, and size 5/6. This accommodates the range of Consensus® Knee posterior stabilized femoral components.
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    K Number
    K954818
    Device Name
    CONSENSUS POSTERIOR STABILIZED KNEE
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-05-22

    (215 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Consensus® Posterior Stabilized Knee is indicated for use in: - 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament. - 2. Failed osteotomy or unicompartmental replacements - 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
    Device Description
    The Consensus® PS Knee tibial insert component is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648), and is designed to articulate with the Consensus® PS femoral component. The insert has a spine on the central eminence which engages the crossbar of the PS femoral component. The spine is positioned so that the crossbar of the PS femoral component engages at approximately 65° flexion. The inferior surface of each component employs dovetail grooves for positive interlocking with the Consensus® Primary Knee tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The Consensus® PS Femoral component is made of CoCrMo alloy (ASTM F75). Both the outer articulating surface and the inner box geometry of the Consensus® PS femoral component are identical to the respective surfaces of the Consensus® Primary Knee femoral component. Therefore, the PS femoral component contains the same deepened patella groove as the Consensus® Primary Knee femoral component for increased range of motion, utilizes the same instrumentation as the Consensus® Knee for preparing the distal femur, and employs smooth distal pegs for added Medial/Lateral stability. The Consensus® PS femoral component has a shortened patella groove to accommodate the spine of the Consensus® PS tibial insert. It also contains a stabilizing bar located between the posterior condyles which engages the spine of the Consensus® PS tibial insert at high flexion angles. The Consensus® Posterior Stabilized Knee System will be provided sterile. The Consensus® Posterior Stabilized Knee is designed for use with the following Consensus® Total Knee System components: Consensus® All Poly or metal back Patellar component Consensus® Porous Titanium Stemmed Tibial Baseplate Consensus® Nonporous Titanium Stemmed Tibial Baseplate Consensus® CoCr Stemmed Tibial Baseplate
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    K Number
    K953443
    Device Name
    CONSENSUS PCL SUBSITUTING TIBIAL INSERT
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-04-26

    (284 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Consensus® PCL Substituting Tibial Insert is indicated for use in: - 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - 2. Failed osteotomy or unicompartmental replacements - 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
    Device Description
    The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The Consensus® PCL Substituting Tibial Insert will be provided sterile.
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    K Number
    K952943
    Device Name
    CONSENSUS ALL POLY TIBIA
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-04-01

    (280 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Consensus® All Poly Tibia is indicated for use in: - 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - 2. Failed osteotomy or unicompartmental replacements - 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
    Device Description
    The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for postoperative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile.
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    K Number
    K960302
    Device Name
    CONSENSUS ACETABULAR SHELL, ALL UHMWPE
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-04-01

    (70 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck. 2. Osteoarthrosis involving femoral and acetabular articular surfaces. 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. 4. Fracture-dislocation of the hip. 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
    Device Description
    The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components. The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.
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    K Number
    K960340
    Device Name
    CONSENSUS APEX DOME HOLE PLUG
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-03-15

    (51 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in: - 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck. - 2. Osteoarthrosis involving femoral and acetabular articular surfaces. - 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. - 4. Fracture-dislocation of the hip. - 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
    Device Description
    The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the the metal acetabilar shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components: Porous coated Acetabular Shell K922561 SE 07/21/93 Nonporous Acetabular Shell K922561 SE 07/21/93 Acetabular Insert, UHMWPE K922561 SE 07/21/93 The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.
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    K Number
    K960151
    Device Name
    CONSENSUS 26MM COCRMO FEMORAL HEAD
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-02-21

    (41 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960156
    Device Name
    CONSENSUS 32MM COCRMO FEMORAL HEAD
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-02-21

    (41 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960339
    Device Name
    CONSENSUS 22MM COCRMO FEMORAL HEAD
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-02-21

    (28 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    U.S. MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955386
    Device Name
    CONSENSUS ZIRCONIA FEMORAL HEAD
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-02-20

    (90 days)

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

    U.S. MEDICAL PRODUCTS, INC.

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

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