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510(k) Data Aggregation

    K Number
    K201072
    Device Name
    Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
    Manufacturer
    Ensemble Orthopedics, LLC
    Date Cleared
    2020-12-02

    (224 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
    Device Description
    The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels. A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.
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    K Number
    K180744
    Device Name
    Stablyx CMC Arthroplasty Implant System
    Manufacturer
    Skeletal Dynamics, LLC
    Date Cleared
    2018-04-11

    (20 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.
    Device Description
    The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) ioint. The single piece prosthesis has a highly polished. saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates aqainst the saddle surface of the trapezium, allowing for flexion-extension, abduction-adduction and opposition motions. The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: Multiple sized hemi joint prosthesis System specific instrumentation
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    K Number
    K111068
    Device Name
    STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
    Manufacturer
    SKELETAL DYNAMICS, LLC
    Date Cleared
    2011-12-30

    (256 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.
    Device Description
    The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. The single piece prosthesis has a highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions. The prosthesis is available in five sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: - Multiple sized hemi ioint prosthesis . - System specific instrumentation .
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    K Number
    K112278
    Device Name
    ASCENSION NUGRIP CMC IMPLANT
    Manufacturer
    ASCENSION ORTHOPEDIC
    Date Cleared
    2011-11-04

    (87 days)

    Product Code
    KYI, CLA
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ascension® NuGrip® CMC Implant is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion.
    Device Description
    The Ascension NuGrip CMC Implant is a single-use, uncemented one-piece implant for the basal thumb joint. It is constructed of a graphite core encased in a layer of pyrolytic carbon. The device is offered in 9 different combinations of 3 head and 4 stem sizes. The NuGrip represents incremental design modifications to the Ascension PyroHemiSphere, including an extended proximal spherical head, a collar at the head base, modified stem geometry, and additional implant sizes.
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    K Number
    K092548
    Device Name
    EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2009-12-15

    (118 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with: - Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb) - Decreased motion, pinch, and grip strength - X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination. - Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity
    Device Description
    The EXTREMITY MEDICAL Trapezium Prosthesis
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    K Number
    K061956
    Device Name
    ARTELON STT SPACER
    Manufacturer
    ARTIMPLANT AB
    Date Cleared
    2007-06-07

    (331 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis.
    Device Description
    ARTELON STT Spacer is a woven one-piece, L-shaped implant made of ARTELON, a polycaprolactone based polyurethaneurea.
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    K Number
    K061954
    Device Name
    ARTELON CMC SPACER ARTHRO
    Manufacturer
    ARTIMPLANT AB
    Date Cleared
    2007-06-01

    (325 days)

    Product Code
    KYI, WRI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Artelon® CMC Spacer Arthro intended to be implanted into first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.
    Device Description
    ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea. ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device. ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.
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    K Number
    K061451
    Device Name
    ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Date Cleared
    2006-08-11

    (78 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ascension® CMC is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
    Device Description
    The Ascension® CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of the carpometacarpal (CMC) joint. The Ascension CMC is a one component prosthesis having a saddle configuration articular surface which bears against the mating saddle articular surface of the trapczium. The saddle design allows for flexion-extension joint motion and abduction-adduction motion. It is designed to be a press fit device. Each device is comprised of a pyrocarbon layer encasing a machined graphite substrate. The graphite substrate material is impregnated with a small amount (I atomic percent) of tungsten. This small amount of tungsten renders the graphite substrate radiopaque. The device is provided sterile in packaging containing a single device.
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    K Number
    K061089
    Device Name
    MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
    Manufacturer
    BIOPRO, INC.
    Date Cleared
    2006-06-20

    (63 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Rheumatoid arthritis 2. Traumatic arthritis 3. Osteoarthritis 4. Post Fracture deformation or bone loss
    Device Description
    Not Found
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    K Number
    K060386
    Device Name
    NEXA CARPO METACARPAL IMPLANT
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Date Cleared
    2006-05-10

    (85 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Product Code :

    KYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb with limited range of motion.
    Device Description
    The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.
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