Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121297
    Device Name
    ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
    Manufacturer
    SIGNATURE ORTHOPAEDICS, PTY, LTD
    Date Cleared
    2012-12-28

    (242 days)

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

    SIGNATURE ORTHOPAEDICS, PTY, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.
    Device Description
    The system is modular and consists of the Signature Orthopaedics Origin™ and NEO-T Hip Stem, Femoral Heads, and PX-Series and G-Series Acetabular Cups. The Signature Orthopaedics Origin™ Hip Stem is manufactured from titanium alloy per ASTM F136 and below the resection line is coated with HA per ISO 13779-2. The stem is straight and tapered with a lateral chamfer to aid insertion. The stem has both vertical and horizontal grooves to resist axial and torsional loading. The Signature Orthopaedics NEO-TTM Hip Stem is a porous coated femoral stem manufactured from titanium alloy per ASTM F136. The proximal stem below the resection line is porous coated with titanium powder per ASTM F1580. The stem is straight and tapered with a rectangular cross-section. The stem has a distal slot and lateral chamfer to ease insertion. Both stems are available in standard and high offset neck geometries. Each stem's neck has a 12/14 morse taper for connection of a Cobalt Chrome or Ceramic (BIOLOX forte or BIOLOX Delta) femoral head. The Logical™ PX-Series and G-Series Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liners. Both series of acetabular cup consist of a porous coated shell manufactured from titanium alloy per ASTM F136, and a modular liner manufactured from cross-linked UHMWPE per ASTM F648. The PX-Series and G-Series shells differ in their shell's porous coating. The PX-Series is coated with titanium beads while the G-series is coated with a combination of titanium beads and particles. Both series of cups are available with either no holes or three holes to allow the use of bone screws to supplement fixation.
    Ask a Question

    Page 1 of 1