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510(k) Data Aggregation

    K Number
    K252824

    Validate with FDA (Live)

    Date Cleared
    2026-03-12

    (188 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

    • Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
    • Inflammatory joint disease including rheumatoid arthritis
    • Correction of functional deformity including congenital hip dysplasia
    • Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
    • Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

    Signature Orthopaedics' Origin, Nebula, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

    Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

    Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

    Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

    Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

    • Acute femoral head or neck fracture
    • Fracture dislocation of the hip
    • Avascular necrosis of the femoral head
    • Non-union of femoral neck fractures
    • Certain high subcapital and femoral neck fractures in the elderly
    • Degenerative arthritis involving only the femoral head
    Device Description

    The Evolve AP and Evolve AP Vit-E Cups are manufactured of UHMWPE and GUR1020-E respectively and are all-polyethylene acetabular cups intended for cemented use. The Evolve Cups are compatible with Signature Orthopaedics Signature Femoral Heads. The Evolve AP Vit-E Constrained Cup is contraindicated for use with Signature Orthopaedics Origin-NS and Cemented TSI Femoral Stem.

    The World Finned Cup is manufactured from Ti6Al4V and is a cementless acetabular cup featuring external fins to provide extra fixation and reduced rotation of the cup. The World Finned Cup is compatible with Signature Orthopaedics World Liners.

    The World G-Zero Liner is manufactured from UHMWPE GUR1020-E and is a constrained acetabular liner for use in conjunction with the Signature Orthopaedics World Cups in total hip arthroplasty. The Oddball Femoral Head is manufactured from CoCr and is compatible with the World G-Zero liners to complete the constrained hip replacement. Both the G-Zero Constrained Liner and the Oddball Femoral Head are contraindicated for use with Signature Orthopaedics Origin-NS and Cemented TSI Femoral Stem.

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