OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.

Product Overview

OSferion is a white porous material composed of β
OSferion - AR-13372-2

Device Description

A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Environmental Conditions

No Data Available

Device Sizes

  • Angle: 75 degree
  • Length: 7 Millimeter
  • Length: 25 Millimeter
  • Length: 9 Millimeter
    • Angle: 75 degree
    • Length: 7 Millimeter
    • Length: 25 Millimeter
    • Length: 9 Millimeter

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: MQV

    Device Name: Filler, Bone Void, Calcium Compound

    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: 888.3045

    Third Party Flag: N

    Medical Specialty: OR

    Device Identifiers

    Device Id: 04560245656968

    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

    Educational Resources