Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K132496
    Device Name
    ARTHROSURFACE TOEMOTION
    Manufacturer
    ARTHROSURFACE, INC.
    Date Cleared
    2014-02-26

    (201 days)

    Product Code
    LZJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only. Indications for use include: - Painful degenerative metatarso-phalangeal joint change . - . Hallus rigidus stage 3 and 4 - . Hallux valgus and hallux rigidus - Hallux limitus with painful arthrofibrosis . - Revisions after moderate proximal phalanx resection .
    Device Description
    The Arthrosurface® Total Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 15 metatarsal head and the base of the proximal phalanx. These two implants replace the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex. The Metatarsal Implant incorporates a CoCrMo articular resurfacing component per ASTM F799 with CP Ti Plasma Spray coating per ASTM F1580 and a Ti-6AI-4V ELI alloy fixation component per ASTM F136 that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The device is 15mm articular implant with a dorsal flange feature for additional implant coverage in the dorsal plane. The Proximal Phalanx Implant consists of a Ti-6Al-4V ELI alloy fixation component per ASTM F136 with CP Ti Plasma Spray coating per ASTM F1580 and an Ultra High Molecular Weight Polyethylene inlay per ASTM F648.
    Ask a Question
    K Number
    K102549
    Device Name
    THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Date Cleared
    2010-12-21

    (105 days)

    Product Code
    LZJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include: - Painful degenerative metatarso-phalangeal joint change . - Hallux rigidus stage 3 and 4 ◆ - Hallux valgus and hallux rigidus . - Hallux limitus with painful arthrofibrosis . - Revisions after moderate proximal phalanx resection .
    Device Description
    The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.
    Ask a Question
    K Number
    K072251
    Device Name
    MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
    Manufacturer
    MERETE MEDICAL GMBH
    Date Cleared
    2008-05-08

    (269 days)

    Product Code
    LZJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint. The device is intended for cemented use only. Indications for use include: - Painful degenerative metatarso-phalangeal joint change - Hallux rigidus stage 3 and 4 - Hallux valgus and hallux rigidus - Hallux limitus with painful arthrofibrosis - Revisions- after moderate proximal phalanx resection
    Device Description
    The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece prosthesis that replaces the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex. The prosthesis consists of an anatomically shaped and polished metatarsal implant, made of CoCrMo, which glides on a polyethylene inlay that is preassembled on a conically shaped phalangeal component made of titanium alloy Ti-6AI-4V. Metatarsal and Phalangeal implant are intended for cemented use only.
    Ask a Question

    Page 1 of 1