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510(k) Data Aggregation

    K Number
    K241241
    Device Name
    Z1 Cemented Hip System
    Manufacturer
    Orchard Medical Development, LLC
    Date Cleared
    2024-08-27

    (116 days)

    Product Code
    LZO, KWL, KWY, KWZ, LWJ, MEH
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orchard Medical Development, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Z1 Cemented Hip System is intended for total or partial (hemi-) hip arthroplasty and is indicated for the following conditions: - · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR). · Acute traumatic fracture of the femoral head or neck. · Avascular necrosis of the femoral head. Z1 Cemented Hip System consists of implants that are for cemented use only.
    Device Description
    The Z1 Cemented Hip System consists of femoral hip stems intended for use in total or partial (hemi-) hip arthroplasty. The stem is designed for cemented implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or partial (hemi-) hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from forged stainless steel and have a wedge-shaped design, with a proximal-to-distal taper. Offered in multiple sizes and neck lengths, the stems are available in standard and high offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Cemented Hip System femoral stems. The Z1 Cemented Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, acetabular shells, acetabular liners, and distal centralizers / positioners identified in the package insert as compatible components.
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    K Number
    K233476
    Device Name
    Z1 Hip System
    Manufacturer
    Orchard Medical Development
    Date Cleared
    2024-02-08

    (106 days)

    Product Code
    LZO, KWY, KWZ, LWJ, MEH
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orchard Medical Development

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions: - · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. - · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). - · Acute traumatic fracture of the femoral head or neck. - · Avascular necrosis of the femoral head. Z1 Hip System is for cementless use only.
    Device Description
    Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region, the entire surface of the stem is grit-blasted and sprayed with a Ti-6Al-4V titanium alloy plasma coating followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The Z1 Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, and acetabular shells and liners identified in the package insert as compatible components.
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