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510(k) Data Aggregation

    K Number
    K202894
    Device Name
    Wiltrom Spinal Fixation System
    Manufacturer
    Wiltrom Corporation Limited
    Date Cleared
    2020-10-23

    (25 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wiltrom Corporation Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wiltrom Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
    Device Description
    The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6AI-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.
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    K Number
    K180758
    Device Name
    Osteocera Resorbable Bone Substitute
    Manufacturer
    Wiltrom Corporation Limited
    Date Cleared
    2018-10-24

    (216 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wiltrom Corporation Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.
    Device Description
    Osteocera Resorbable Bone Substitute is a bioceramic medical device that consists of over 95% beta-tricalcium phosphate (ß-TCP). Osteocera is a resorbable implant intended to fill bony voids or gaps that are caused by trauma or surgery and are not intrinsic to the skeletal stability. The interconnected porous structure of Osteocera provides a matrix for bone ingrowth. Osteocera Resorbable Bone Substitute is for single use only and is supplied sterile in sticks and granules with various sizes and package volumes.
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    K Number
    K172237
    Device Name
    Bicera Resorbable Bone Substitute
    Manufacturer
    Wiltrom Corporation Limited
    Date Cleared
    2018-02-02

    (192 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wiltrom Corporation Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). The bone graft can be used as a bone filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The composite material is gradually resorbed and replaced by bone tissues. Bicera® Resorbable Bone Substitute is supplied sterile in various shapes and sizes.
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    K Number
    K172548
    Device Name
    Wiltrom Spinal Fixation System
    Manufacturer
    Wiltrom Corporation Limited
    Date Cleared
    2018-01-12

    (142 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wiltrom Corporation Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wiltrom Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
    Device Description
    The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.
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    K Number
    K110949
    Device Name
    BICERA (TM) RESORBABLE BONE SUBSTITUTE
    Manufacturer
    WILTROM CORPORATION LIMITED
    Date Cleared
    2012-09-18

    (533 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILTROM CORPORATION LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bicera™ Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera™ Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera™ Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    Bicera™ Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (B-TCP). Bicera™ is a bone void filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. This composite material is acretts resumity in vivo and is replaced by new bone. Bicera™ Resorbable Bone Substitute is supplied sterile in various shapes and sizes.
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