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510(k) Data Aggregation

    K Number
    K212741
    Device Name
    EZYPOR
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2022-06-24

    (298 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZYPOR® orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.
    Device Description
    EZYPOR® orbital implants are high density polyethylene (UHMWPE) implants designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation procedures. The polyethylene material has an open porosity structure of 40 to 60%. The implants are available in six diameter sizes, 12, 14, 16, 18, 20 and 22 mm. EZYPOR® orbital implants are supplied sterile and are sterilized by ethylene oxide.
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    K Number
    K123764
    Device Name
    DURETTE OCULAR IMPLANT
    Manufacturer
    OCULO-PLASTIK, INC.
    Date Cleared
    2013-01-31

    (55 days)

    Product Code
    HPZ, EST
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.
    Device Description
    The Durette implant is a quasi-spherical ocular implant made in 4 models for variations in anterior surface. Each has a permanent smooth surface and many tunnels to allow direct suturing of the muscles. These 20 interconnected tunnels, all situated in the anterior 3rd of the implant, allow tissue integration or ingrowth to help stabilize the implant. Each has an off-center elongation.
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    K Number
    K110554
    Device Name
    BIOCERAMIC ORBITAL IMPLANT, ORBTEX
    Manufacturer
    CERAMISYS LTD.
    Date Cleared
    2011-11-02

    (247 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.
    Device Description
    Not Found
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    K Number
    K112176
    Device Name
    SILICONE SPHERES
    Manufacturer
    OCULO PLASTIK, INC.
    Date Cleared
    2011-09-15

    (49 days)

    Product Code
    HPZ, EST
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.
    Device Description
    Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surqically remove the eye (enucleation), the contents of the eve sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis. Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include: Description, Appearance, Indications, Silicone sphere, Mode of action, Contra-indications, Adverse effects, Recommendation for use, Precautions for use. They are available by units in a wide range of sizes, from 12 to 22mm.
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    K Number
    K083342
    Device Name
    ORBITAL RECONSTRUCTIVE IMPLANT II
    Manufacturer
    EVERA MEDICAL, INC.
    Date Cleared
    2009-03-12

    (120 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORI II is intended for augmentation or restoration in the craniofacial region. The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.
    Device Description
    The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.
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    K Number
    K082850
    Device Name
    EYE SPHERES
    Manufacturer
    PRODUCT AND EDUCATIONAL SERVICES LLC
    Date Cleared
    2009-02-27

    (151 days)

    Product Code
    HPZ, HQN
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration) Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process
    Device Description
    When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.
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    K Number
    K073293
    Device Name
    DURETTE IMPLANT
    Manufacturer
    OCULO PLASTIK, INC.
    Date Cleared
    2008-03-19

    (117 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.
    Device Description
    The Durette Implant is an acrylic (PMMA) ocular implant available in 4 models. It is quasi-spherical with a smooth surface and a network of 20 interconnected tunnels in the anterior third for suturing muscles and tissue ingrowth. Each model has a slight off-center medial elongation. The models vary in the amount of anterior surface detail, ranging from as spherical as possible with a slight double radius front (#1), to having minute details (#2), low mounds (#3), and still higher mounds (#4). The implants are molded in 2 parts and welded together.
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    K Number
    K071335
    Device Name
    MEDPOR ATTRACTOR IMPLANT
    Manufacturer
    POREX SURGICAL, INC.
    Date Cleared
    2007-08-08

    (89 days)

    Product Code
    HPZ, MQU
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEDPOR ATTRACTOR Implant is intended for patients who require replacement of volume of an enucleated or eviscerated orbit and who wish to gain improved prosthetic eye motility by coupling the MEDPOR ATTRACTOR Implant to the prosthetic eye.
    Device Description
    MEDPOR Orbital Implant made of porous polyethylene with a titanium nitride coated stainless steel screw or insert. The screw or insert acts as an attractor to a magnet that is embedded into the posterior of a prosthetic eye. The magnets are gold plated and designed small enough to remain entirely within the prosthesis material of the prosthetic eye, and powerful enough to provide a coupling force between the implant and the prosthesis.
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    K Number
    K070130
    Device Name
    ORBITAL RECONSTRUCTIVE IMPLANT
    Manufacturer
    BECKER & ASSOCIATES CONSULTING INC
    Date Cleared
    2007-04-19

    (93 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.
    Device Description
    The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.
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    K Number
    K053298
    Device Name
    ALPHASPHERE ORBITAL IMPLANT
    Manufacturer
    HYDRON PTY LIMITED
    Date Cleared
    2006-05-09

    (165 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    HPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlphaSphere Orbital Implant is intended to replace orbital volume after loss of an eye through enucleation or evisceration, including secondary implantation after removal of an existing, unsatisfactory, orbital implant. The device is indicated in any situation where silicone, acrylic, polyethylene, coral, glass, or other traditional orbital implants are used.
    Device Description
    The AlphaSphere Orbital Implant is aspherical orbital volume replacement prosthesis with a posterior gel hemisphere resistant to tissue ingrowth and an anterior hemisphere with a spongy outer surface designed to encourage tissue attachment. The implant is made entirely of a flexible hydrogel, poly (2-hydroxyethyl methacrylate). (PHEMA). The physical differences between the gel and spongy portions of the implant are created by varying the conditions during the hydrogel polymerization process. The transition between the two hydrogel regions is reinforced with a biocompatible synthetic mesh (MERSILENE) beneath the device surface to improve mechanical strength for the passage of sutures.
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