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510(k) Data Aggregation

    K Number
    K162354
    Device Name
    Sniper Staple System
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2017-04-20

    (240 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.
    Device Description
    The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.
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    K Number
    K130964
    Device Name
    GRIDLOCK PLATING SYSTEM
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2013-05-08

    (30 days)

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

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
    Device Description
    Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and the necessary instruments to facilitate the placement of these implants.
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    K Number
    K123525
    Device Name
    GRIDLOCK PLATING SYSTEM
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2013-02-15

    (92 days)

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

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
    Device Description
    Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
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    K Number
    K122959
    Device Name
    HAMMER TOE IMPLANT
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2012-11-07

    (43 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.
    Device Description
    The Hammer Toe Implant is a threaded/spaded device used for bone fixation in the phalanges of the lesser digits in the foot and hand. The implant, which is a cannulated, threaded and spaded device, is offered in multiple diameters and lengths. The system will also consist of K-wires (K121008) to be used in the delivery of the implant and also for use of temporary stabilization of outlying joints.
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    K Number
    K121452
    Device Name
    GRIDLOCK PLATING SYSTEM
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2012-08-20

    (96 days)

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

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates and screws are intended for single use only.
    Device Description
    The Gridlock Plating System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited bone contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters. Materials: CP Titanium per ASTM F67 Titanium alloy per ASTM F136
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    K Number
    K121008
    Device Name
    TRILLIANT SURGICAL K-WIRES
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2012-06-04

    (62 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trilliant Surgical K-wires are intended for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants.
    Device Description
    K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. Two diameters, Ø0.045" (Ø1.143 mm) and Ø0.062" (Ø1.57 mm), of the Trilliant Surgical K-Wires are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. Materials: 316L Stainless Steel per ASTM F138 Function: The K-wires are used to hold bone fragments together (pin fixation), to provide an anchor for skeletal traction and as guide pins for insertion of other implants.
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    K Number
    K111834
    Device Name
    DISCO SUBTALAR IMPLANT
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2011-12-06

    (160 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disco Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.
    Device Description
    The Disco Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The leading end of the implant is cylindrical in shape and is approximately half of the overall length of the device, with the remaining length being spherical. The full length of the implant incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. Internal threads are machined in the spherical end of the implant and are for use with a removal tool.
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    K Number
    K112737
    Device Name
    TIGER HEADLESS CANNULATED SCREWS
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2011-10-20

    (30 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
    Device Description
    Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
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    K Number
    K103183
    Device Name
    TRILLIANT SURGICAL SUBTALAR IMPLANT
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2011-02-08

    (103 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.
    Device Description
    The Trilliant Surgical Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm to Ø12mm in 1mm increments.
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    K Number
    K081510
    Device Name
    TIGER CANNULATED SCREW SYSTEM
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2008-08-04

    (67 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIANT SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
    Device Description
    The Tiger Cannulated Screw System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy. The system features 2.0mm diameter, 2.4mm diameter, 3.0mm diameter and 4.0mm diameter cannulated screws. System instruments include 2.0mm/2.4mm drill bit, countersink, driver, 3.0mm/4.0mm drill bit, countersink, driver, screw driver handle, depth gauge, screw remover and K-wires to facilitate the placement of screws.
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