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510(k) Data Aggregation

    K Number
    K193247
    Device Name
    LATITUDE EV™ Total Elbow Arthroplasty
    Manufacturer
    Tornier Inc.
    Date Cleared
    2020-08-05

    (254 days)

    Product Code
    JDB, JDC
    Regulation Number
    888.3160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LATITUDE EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques. The LATITUDE EV™ Total Elbow Arthroplasty system is intended for cemented use only.
    Device Description
    The LATITUDE EVI™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The LATITUDE EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semiconstrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.
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    K Number
    K191711
    Device Name
    ORTHOLOC™ SPS Shoulder Plating System
    Manufacturer
    Tornier Inc.
    Date Cleared
    2019-07-17

    (21 days)

    Product Code
    HRS, HWC, KTT, KTW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
    Device Description
    The ORTHOLOC™ SPS Shoulder Plating System is designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking screws manufactured from stainless steel per ASTM F2229 and non-locking screws manufactured from stainless steel per ASTM F138 or ASTM F2229. The system is provided non-sterile and requires steam sterilization prior to use.
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    K Number
    K182461
    Device Name
    LATITUDE EV Total Elbow Arthroplasty
    Manufacturer
    Tornier Inc.
    Date Cleared
    2018-12-27

    (108 days)

    Product Code
    JDB, JDC
    Regulation Number
    888.3160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Latitude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques. The Latitude EV™ Total Elbow Arthroplasty system is intended for cemented use only.
    Device Description
    The Latitude EV™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.
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    K Number
    K181587
    Device Name
    ORTHOLOC SPS Shoulder Plating System
    Manufacturer
    Tornier Inc.
    Date Cleared
    2018-10-05

    (112 days)

    Product Code
    HRS, HWC, KTT, KTW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
    Device Description
    ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use.
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    K Number
    K171010
    Device Name
    Latitude EV Total Elbow Arthroplasty
    Manufacturer
    Tornier Inc.
    Date Cleared
    2017-08-31

    (149 days)

    Product Code
    JDB, JDC
    Regulation Number
    888.3160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tornier Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lattude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques. The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.
    Device Description
    The Latitude EV™ Total Elbow Arthroplasty system is a 2- or 3-part total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the elbow. The prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only. The Latitude EV™ humeral and ulnar stems are available in multiple sizes for primary and revision surgery and include a plasma spray coating. The optional radial implant is uncoated and is available in several sizes corresponding to the humeral and ulnar construct size selected.
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