INITIA STEM HO #10


Product Overview

INITIA STEM HO #10
Initia Total Hip System - GMH02-500047


Device Description

A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.


Environmental Conditions

No Data Available


Device Sizes

  • Stem offset: 53mm
  • Neck length: 40mm
  • Stem length: 117mm
  • Taper: 12/14
  • Stem: High offset
  • Size: #10
    • Stem offset: 53mm
    • Neck length: 40mm
    • Stem length: 117mm
    • Taper: 12/14
    • Stem: High offset
    • Size: #10


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LPH

    Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 888.3358

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 04547898305078

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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