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510(k) Data Aggregation

    K Number
    K181192
    Device Name
    PIP Fix
    Manufacturer
    Hand Biomechanics Lab, Inc.
    Date Cleared
    2018-10-22

    (171 days)

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

    Hand Biomechanics Lab, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIP Fix is indicated for the treatment of unstable dorsal fracture dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the PIP Fix alone is sufficient to obtain and maintain concentric reduction of the fracture dislocation during bone and soft tissue healing.
    Device Description
    The PIP Fix is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture dislocation of the proximal interphalangeal (PIP) joint. This device is capable of exerting both palmar translation and distal length restoration forces on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the PIP Fix is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues. The PIP Fix is installed by a surgeon in a healthcare facility / hospital environment. Included with the gamma irradiated, sterile PIP Fix is a Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. A Dorsal Bone Pin is inserted vertically into the middle phalanx. The device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating forces that hold the joint concentrically reduced. The device enables the surgeon to determine the distribution of the direction of the forces between palmar translation and distal length restoration. This is accomplished by rotating the Elastic Band posts about an arc concentric with the PIP joint axis such that the force vector resolution may be purely in a palmar translation direction or a combination of palmar translation and length restoration. An Angle Lock Screw locks the device in the chosen position to maintain the force distribution. A Tension Adjust Screw on the PIP Fix allows the surgeon to adjust the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to maintain joint alignment. The PIP Fix is manufactured using metal and Ultem plastic. The Bone Pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only. The device is typically worn for 6 to 8 weeks depending on the rate of healing and the surgeon's assessment of the same. During this time, the Bone Pins are the only portion of the device contacting or penetrating the skin in a non-transient manner.
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    K Number
    K072432
    Device Name
    F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Date Cleared
    2008-01-09

    (133 days)

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

    HAND BIOMECHANICS LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.
    Device Description
    The F3 Fractured Finger Fixator is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint. This device exerts a volarly translating force on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the F3 is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues. Included with the F3 is a custom designed Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. The Dorsal Bone Pin inserted vertically into the middle phalanx. The F3 device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating force that holds the joint concentrically reduced. A Tension Adjust Screw on the F3 allows the surgeon to "fine frune" the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to me ' tain joint alignment. The F3 Fractured Finger Fixator is manufactured using metal and plastic. The bone pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only.
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    K Number
    K033112
    Device Name
    WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Date Cleared
    2003-11-05

    (36 days)

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

    HAND BIOMECHANICS LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fracture reduction and external fixation for treatment of distal radius fractures.
    Device Description
    The WristJack ORIF System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins. The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, carbon fiber, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.
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    K Number
    K030519
    Device Name
    WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Date Cleared
    2003-06-10

    (111 days)

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

    HAND BIOMECHANICS LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fracture reduction and external fixation for treatment of distal radius fractures.
    Device Description
    The WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction frame (fixator), application instrumentation and skeletal fixation pins. The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.
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    K Number
    K992970
    Device Name
    DIGIT WIDGET
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Date Cleared
    1999-11-08

    (66 days)

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

    HAND BIOMECHANICS LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hand Biomechanics Lab, Inc. Digit Widget is intended for use in treating PIP joint flexion contractures with an associated loss of range of motion.
    Device Description
    The Digit Widget is an external fixation system designed to effect rotation of an injured or diseased finger, to help regain, maintain, or increase the range of motion of the proximal interphalangeal (PIP) joint. It utilizes standard small diameter bone pin (Kirschner wire) fixation techniques and procedures for placement. The device acts about the PIP joint and allows some adjustability to permit fine tunive to the joint's axis. During treatinent, the surgeon or hand therapist (under order from the physician) may be required to periodically adjust the torque provided by the traction mechanism, by changing or adding orthodontic elastic can be removed temporarily to permit active range of motion exercise. The Digit Widget traction device is made from plastic and materials. Fixation pins (Kirschner wires) are made from implant grade stainless steel. An included wrist splint is made of neoprene and nylon, with Velcro attachment provisions. All components are designed for single use only.
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    K Number
    K984442
    Device Name
    AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Date Cleared
    1999-02-12

    (60 days)

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

    HAND BIOMECHANICS LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fracture reduction and external fixation for treatment of distal radius fractures.
    Device Description
    The Agee-WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins. The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.
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