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510(k) Data Aggregation

    K Number
    K242973
    Device Name
    CanMINI Hand and Foot System
    Manufacturer
    CANWELL MEDICAL CO., LTD.
    Date Cleared
    2025-04-24

    (210 days)

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

    CANWELL MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CanMINI Hand and Foot System is indicated for fixation of small bones and small bone fragments in the hand and foot. The devices are intended to be single-use and sterilized before use.
    Device Description
    The CanMINI Hand and Foot System, manufactured by CANWELL MEDICAL CO. LTD., is an orthopedic fixation system designed to stabilize fractures or osteotomies of the small bones in the hand and foot. The system includes a variety of bone plates and screws made from high-quality titanium and titanium alloy, ensuring both strength and biocompatibility. The primary materials used in the CanMINI Hand and Foot System are pure titanium, conforming to ASTM F67 standards, and titanium alloy, conforming to ASTM F1472 standards. The CanMINI Hand and Foot System consists of multiple components, each designed to address specific clinical needs in orthopedic surgery. The key components are bone plates and bone screws. The bone plates include straight type bone plates such as models FZSQ01 Ⅰ, FZSQ12, FZSQ38, FZSQ39Ⅰ, FZSQ39Ⅱ, FZSQ39Ⅲ, FZSQ40Ⅰ, and FZSQ40Ⅱ, as well as supporting type non-locking bone plates like models FBC54Ⅰ, FBC54Ⅱ, FBC55, FBC56, and FBC58. Additionally, the system features supporting type locking bone plates including models FBCS29, FBCS57Ⅰ, FBCS57Ⅱ, FBCS59, FBCS60, FBCS86, FBCS87, FBCS88, FBCS89, FBCS96Ⅰ, FBCS96Ⅱ, FBCS99Ⅰ, FBCS99Ⅱ, FBCS132, FBCS134, and FBCS135. The bone screws are also categorized into different types, including metal non-locking bone screws with models FHAQ02 Ⅰ, FHAQ03 Ⅰ, FHAQ06 Ⅰ, metal locking screws with models FHAS04 Ⅰ, FHCS04 Ⅰ, and cannulated screws with model FGJYD Ⅹ. The bone plates and screws in the CanMINI Hand and Foot System come in a range of sizes to accommodate different anatomical and clinical requirements. For example, the 6-hole 1.5mm phalangeal metacarpal locking plate has dimensions of 29.7 mm in length, 4.7 mm in width, and 0.95 mm in thickness, while the 8-hole 2.4mm condylar locking plate has dimensions of 59.0 mm in length, 6.5 mm in width, and 1.4 mm in thickness. The CanMINI Hand and Foot System is intended for the stabilization of fractures and osteotomies in the small bones of the hand and foot. It provides mechanical support to the bone during the healing process by maintaining proper alignment and stabilizing the fracture site. The system is designed to be used by orthopedic surgeons in various clinical scenarios involving bone fractures, including but not limited to, calcaneal fractures, fracture displacements, and non-union fractures. The clinical benefits of the system include providing critical stabilization and support during the healing of orthopedic fractures. This system aids in the proper alignment of fractured bones, enhances the healing process, and reduces the likelihood of complications such as malunion or delayed union. The CanMINI Hand and Foot System is supplied in a non-sterile state and must be sterilized before use. It is intended for single use only.
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    K Number
    K161151
    Device Name
    Spinal fixation system
    Manufacturer
    CANWELL MEDICAL CO., LTD.
    Date Cleared
    2016-09-21

    (149 days)

    Product Code
    MNH, KWP, MNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANWELL MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spinal fixation system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.
    Device Description
    Spinal fixation system is mainly constituted by pedicle screw, reduction pedicle screw, Set screw, Spine Hook, Rod and Transverse linking pole assembly. Through using the assembly of the screws, rods and/or poles, there will be established a firm frame structure on the Spinal (conforming to the bio-mechanics principle). The components of the system include: pedicle screw, reduction pedicle screw, set screw, spine hook, rod and transverse linking pole assembly and so on. According to the different specification of the rod's diameter and the different usage on the spinal segments, the system is classified: J2X03, J2X04, J2X07..
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