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510(k) Data Aggregation

    K Number
    K122936
    Device Name
    ANKLE TRAUMA SYSTEM
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2013-02-28

    (157 days)

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

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.
    Device Description
    The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.
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    K Number
    K113006
    Device Name
    I-FUSE HAMMER TOE SYSTEMS
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2012-05-25

    (231 days)

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

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
    Device Description
    The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.
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    K Number
    K093055
    Device Name
    CSTS SCREW
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2010-11-22

    (418 days)

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

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho-Pro CSTS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions: - Severely pronated foot . - Calcaneal stance position greater than 5° . - Manually correctable deformities . - . Mid-tarsal breech (arch pain) - Forefoot varus greater than 10° .
    Device Description
    The Ortho-Pro CSTS Screw 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 conical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. External flattened threads increase ease of insertion. It is available in five sizes, Ø8mm to Ø12mm in 1mm increments.
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    K Number
    K073228
    Device Name
    DC ULNAR SHORTENING SYSTEM
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2008-02-29

    (106 days)

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

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DC Ulnar Shortening System provides fixation for osteotomies of the ulna.
    Device Description
    The DC Ulnar Shortening System is an implant intended for fixation of the ulna to assist healing. The implant is fabricated from titanium alloy. It is fixated with 3.5mm fixation screws and a 3.5mm self drilling self tapping headless interfragmentary screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.
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    K Number
    K070555
    Device Name
    ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2007-07-13

    (136 days)

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

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPro Steinman Pins and Kirschner Wires are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
    Device Description
    The OrthoPro Steinman Pins and Kirschner Wires are offered in a variety of lengths, diameters, tip styles, and threading. These devices are constructed of implant grade 316LVM stainless steel conformant to ASTM F138, are provided non-sterile, and are intended for single-use only. The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading. All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138. The devices will range in diameter from 0.028 inches to 0.1875 inches. The devices range in length from 4 inches to 12 inches. The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point. The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round. The devices will be provided in fully threaded, partially threaded and nonthreaded versions.
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    K Number
    K071243
    Device Name
    METAL HEMI IMPLANT
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2007-05-23

    (20 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Metal Hemi Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
    Device Description
    The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
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    K Number
    K062908
    Device Name
    ORTHROPRO HEMI TOE
    Manufacturer
    ORTHOPRO LLC
    Date Cleared
    2006-11-13

    (47 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOPRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho/Pro Hemi Toe is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
    Device Description
    The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adiacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, majntain range of motion and reduce pain without altering the joint biomechanics. The Hemi Tor requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
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