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510(k) Data Aggregation

    K Number
    K061564
    Device Name
    PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Date Cleared
    2006-09-01

    (88 days)

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

    PORTLAND ORTHOPAEDICS PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use: • The patient should be skeletally mature. · The patient's condition should be due to one or more of the following: 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Tumor conditions involving the upper third of the femur or of the Acetabular. 4. Ankylosing spondylitis. 5. Psoriatic arthritis. 6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein. 7. Non union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
    Device Description
    The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.
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    K Number
    K053417
    Device Name
    M-COR HIP REPLACEMENT SYSTEM
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Date Cleared
    2006-07-20

    (224 days)

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

    PORTLAND ORTHOPAEDICS PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M-COR Modular Hip System has the following indications for use: - · The patient should be skeletally mature. - · The patient's condition should be due to one or more of the following: - Osteoarthritis. 1. - 2. Rheumatoid arthritis. - 3. Ankylosing spondylitis - 4. Psoriatic arthritis. - 5. Tumor conditions involving the upper third of the femur or of the acetabulum - Old osteomyelitis with a long infection-free period and a normal WBC, ESR 6. and C-reactive protein. - 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head. - 8. Post-traumatic fracture/dislocation of the hip. - Revision of an unsuccessful arthrodesis with either poor positioning or pain in 9. the hip, or where low back pain or knee pain is becoming disabling. - 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. - 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
    Device Description
    The M-COR (Modular – Center of Rotation) Hip Replacement System is a modular femoral neck and stem component system, to be used for cementless applications. The M-COR Hip Replacement System is comprised of two units: the first is a Commercially Pure Titanium (CPT) coated femoral stem component manufactured from titanium alloy (Ti-6Al-4V). The second is a femoral neck component from either titanium alloy (Ti-6Al-4V) or cobalt-chrome.
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    K Number
    K051844
    Device Name
    EQUATOR PLUS ACETABULAR CUP SYSTEM
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Date Cleared
    2005-10-07

    (92 days)

    Product Code
    MAY, JDI, LWJ
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTLAND ORTHOPAEDICS PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Equator Plus™ Acetabular Cup System has the following indications for use: - The patient should be skeletally mature. - The patient's condition should be due to one or more of the following: 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Tumor conditions involving the upper third of the femur or of the Acetabular. 4. Ankylosing spondylitis. 5. Psoriatic arthritis. 6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein. 7. Non union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
    Device Description
    The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.
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    K Number
    K032641
    Device Name
    MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Date Cleared
    2004-01-20

    (146 days)

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

    PORTLAND ORTHOPAEDICS PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MARGRON™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Osteoarthritis, Rheumatoid arthritis, Tumor conditions involving the upper third of the femur or the acetablym, Ankylosing spondylitis, Psoriatic arthritis, Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein, Non union of femoral neck fracture or avascular necrosis of the femoral head, Post-traumatic fracture/dislocation of the hip, Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling, Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present, Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
    Device Description
    The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The MARGRON TM Femoral Stem is a modular prosthesis consisting of - A tapering stem cone with two different speed external threads and longitudinal . derotation columns. - A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion. - . Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation. - . A unique set of instruments have been designed to insert and extract the prosthesis.
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    K Number
    K992815
    Device Name
    THE MARGRON HIP REPLACEMENT SYSTEM
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY. LTD.
    Date Cleared
    2000-02-07

    (171 days)

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

    PORTLAND ORTHOPAEDICS PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Margron™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: - Osteoarthritis - Rheumatoid arthritis - Ankylosing spondylitis - Psoriatic arthritis - Old osteomyelitis with a long infection free period and a normal WBC, C- Reactive protein and ESR - Non union of femoral neck fracture or avascular necrosis of the femoral head - Post-traumatic fracture/dislocation of the hip - Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling - Revision of an unsuccessful uncemented or cemented hip replacement stem, providing sufficient bone stock is present - Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
    Device Description
    The Margron™ hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The Margron™ Femoral Stem is a modular prosthesis consisting of: - A tapering stem cone with two different speed external threads and longitudinal derotation columns. - A neck component which allows the optimum angle of anteversion to be selected after stem insertion. - Precision milling and tapping is used to prepare the femur, and stem insertion is by 'screw home' rotation. - A unique set of instruments have been designed to insert and extract the prosthesis.
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