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510(k) Data Aggregation

    K Number
    K190599
    Device Name
    Aptis Medical Distal Radio Ulnar Joint Implant
    Manufacturer
    Aptis Medical, LLC
    Date Cleared
    2019-05-03

    (56 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - · Pain and weakness of the wrist joint not improved by non-operative treatment - · Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radio ulnar joint - · Failed ulnar head resection; e.g. Darrach resection - · Primary replacement after fracture of the ulnar head or neck. - · Revision following failed ulnar head arthroplasty. This prosthesis is intended for single use only.
    Device Description
    The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.
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    K Number
    K142569
    Device Name
    Aptis Medical Distal Radio Ulnar Joint Implant
    Manufacturer
    APTIS MEDICAL, LLC.
    Date Cleared
    2015-04-03

    (203 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aptis Medical Distal Radio Ulnar Joint implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint - Failed ulnar head resection; e.g. Darrach resection - Primary replacement after fracture of the ulnar head or neck. - Revision following failed ulnar head arthroplasty. This prosthesis is intended for single use only.
    Device Description
    The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including; Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head. The device consists of a plate of various sizes which is fixed to the radius and a stem of various sizes which is fixed to the ulna.
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    K Number
    K112481
    Device Name
    FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
    Manufacturer
    ASCENSION ORTHOPEDIC
    Date Cleared
    2012-04-09

    (224 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment. The First Choice Partial Ulnar Head implant is intended for press-fit use.
    Device Description
    The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.
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    K Number
    K081025
    Device Name
    ISOELASTICU
    Manufacturer
    REMI SCIENCES, INC.
    Date Cleared
    2008-11-21

    (225 days)

    Product Code
    KXE, KXF
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications - -Rheumatoid arthritis with or without tendon ruptures - -Degenerative arthritis or post traumatic arthritis - 1. Arthrofibrosis of the DRUJ o - 2. Reconstruction of the distal ulna post tumor resection o - 3. Failed Ulnar Head Resection 0 - 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes - 5. Revision following failed ulnar head arthroplasty O - Ulna stems are intended for uncemented use -
    Device Description
    The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.
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    K Number
    K082839
    Device Name
    DISTAL RADIO-ULNAR JOINT IMPLANT
    Manufacturer
    APTIS MEDICAL, LLC.
    Date Cleared
    2008-10-24

    (28 days)

    Product Code
    KXE, COM
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint - Failed ulnar head resection; eg. Darrach resection - Primary replacement after fracture of the ulnar head or neck. - Revision following failed ulnar head arthroplasty.
    Device Description
    The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
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    K Number
    K061146
    Device Name
    SBI ULNAR HEAD IMPLANT
    Manufacturer
    SMALL BONE INNOVATIONS INC.
    Date Cleared
    2006-07-19

    (85 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.
    Device Description
    The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.
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    K Number
    K053119
    Device Name
    DISTAL RADIO-ULNAR JOINT IMPLANT
    Manufacturer
    APTIS MEDICAL, LLC.
    Date Cleared
    2005-12-07

    (30 days)

    Product Code
    KXE, COM, ORI
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment . - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint - Failed ulnar head resection; eg. Darrach resection . - Primary replacement after fracture of the ulnar head or neck. . - Revision following failed ulnar head arthroplasty. .
    Device Description
    The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
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    K Number
    K052137
    Device Name
    ASCENSION MUH
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Date Cleared
    2005-11-03

    (90 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ascension® MUH is intended for replacement of the distal radioulnar joint: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following: - Pain and weakness of the wrist joint not improved by conservative treatment . - Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes - Failed ulnar head resection .
    Device Description
    The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of the ulnar head. Components will be available in three head sizes, and nine stem sizes which are assembled by means of a taper connection. Device components are made from cobalt chromium alloy meeting ASTM F1537 and titanium Ti6A14V ELI meeting ASTM F136, the same materials used to fabricate other ulnar head prostheses that have market clearance for sale in the United States.
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    K Number
    K040497
    Device Name
    DISTAL RADIO-ULNAR JOINT IMPLANT
    Manufacturer
    APTIS MEDICAL, LLC.
    Date Cleared
    2005-01-26

    (335 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint - Failed ulnar head resection; eg. Darrach resection - Primary replacement after fracture of the ulnar head or neck. - Revision following failed ulnar head arthroplasty.
    Device Description
    The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
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    K Number
    K042902
    Device Name
    HERBERT ULNAR HEAD PROSTHESIS SYSTEM
    Manufacturer
    STUCKENBROCK MEDIZINTECHNIK GMBH
    Date Cleared
    2004-12-27

    (68 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Product Code :

    KXE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.
    Device Description
    The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.
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