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510(k) Data Aggregation

    K Number
    K212297
    Device Name
    Omni Foot and Ankle Plating System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2021-08-20

    (29 days)

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

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
    Device Description
    The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
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    K Number
    K211261
    Device Name
    Axis Charcot Fixation System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2021-05-28

    (32 days)

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

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
    Device Description
    The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.
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    K Number
    K201556
    Device Name
    Intraosseous Fixation System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2020-07-08

    (28 days)

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

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.
    Device Description
    The Extremity Medical Intraosseous Fixation System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of the small bones and joints of the hand, wrist, foot, and ankle. The system consists of solid and cannulated screws, with the option of adding Washers; a standard/flat Washer, a Washer Post (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip for engaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths. Similarly, the lag screws come in varying diameters and lengths, and are also available in short and long thread configurations. The modified device is a product line extension and improvement to the Screw and Washer System, cleared under K121349, intended to provide modularity to the end user. New components to the system consist of cannulated 3.5 mm screws and implant accessories, X-Posts and X-Clips, to offer surgeons options for placement. Additionally, the system will offer additional thread length options for the 4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to those cleared under K121349.
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    K Number
    K191525
    Device Name
    KinematX Total Wrist Arthroplasty System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2020-03-04

    (268 days)

    Product Code
    JWJ
    Regulation Number
    888.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by: 1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease 2. Revision where other devices or treatments have failed 3. Scapholunate Advanced Collapse (SLAC) 4. Rheumatoid Arthritis The device is intended to be implanted with bone cement.
    Device Description
    The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components: 1) Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray 2) Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.
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    K Number
    K192592
    Device Name
    Axis Plating System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2019-11-21

    (62 days)

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

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).
    Device Description
    The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by geometry and number of holes. The plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be used as adjunctive fixation. The 4.0mm cannulated screws and beams can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
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    K Number
    K172260
    Device Name
    Omni Foot Plating System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2017-11-06

    (102 days)

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

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.
    Device Description
    The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Peg") which contains a locking feature at the distal end for compression/stabilization.
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    K Number
    K171018
    Device Name
    Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
    Manufacturer
    Extremity Medical, LLC.
    Date Cleared
    2017-07-13

    (99 days)

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

    Extremity Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Axis Charcot Fixation System: The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthopathy (Charcot). 4.5 to 8.5 Screw System: The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.
    Device Description
    Axis Charcot Fixation System The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. 4.5 to 8.5 Screw System The 4.5 to 8.5 diameter screws consists of cannulated, titanium alloy fixation screws for use in bone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot.
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    K Number
    K133636
    Device Name
    EXTREMITY MEDICAL HAMMERTOE DEVICE
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Date Cleared
    2014-03-28

    (122 days)

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

    EXTREMITY MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
    Device Description
    The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK implant and a set of instruments used for implant site preparation and delivery. The device is offered in small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.
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