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510(k) Data Aggregation

    K Number
    K140226
    Device Name
    OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
    Manufacturer
    SCIENCE FOR BIOMATERIALS
    Date Cleared
    2014-06-03

    (125 days)

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

    SCIENCE FOR BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.
    Device Description
    The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate): - The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced. - The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).
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    K Number
    K120818
    Device Name
    OTIS-C PLUS
    Manufacturer
    SCIENCE FOR BIOMATERIALS
    Date Cleared
    2012-04-19

    (31 days)

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

    SCIENCE FOR BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies
    Device Description
    The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTIS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.
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    K Number
    K090994
    Device Name
    LIGAFIX INTERFACE SCREW
    Manufacturer
    SCIENCE FOR BIOMATERIALS
    Date Cleared
    2009-05-06

    (29 days)

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

    SCIENCE FOR BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LIGAFIX® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
    Device Description
    LIGAFIX® / ComposiTCP® range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® / ComposiTCP® interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite. LIGAFIX® / ComposiTCP® interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX® 60/ ComposiTCP® 60) and 30/70 (LIGAFIX® 30/ ComposiTCP® 30) LIGAFIX® / ComposiTCP® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches.
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    K Number
    K071155
    Device Name
    MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
    Manufacturer
    SCIENCE FOR BIOMATERIALS
    Date Cleared
    2007-07-03

    (69 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENCE FOR BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070507
    Device Name
    MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
    Manufacturer
    SCIENCE FOR BIOMATERIALS
    Date Cleared
    2007-03-29

    (36 days)

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

    SCIENCE FOR BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
    Device Description
    LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction. To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise: - 2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA) - 3 head design: standard reduced -- rounded ಂ - Diameters from 7 mm to 11 mm 0 - Lengths from 20 mm to 35 mm ಂ LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.
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    K Number
    K061022
    Device Name
    BIO 1-KIT BIOSORB FILLED CARTRIDGE
    Manufacturer
    SCIENCE FOR BIOMATERIALS
    Date Cleared
    2006-05-24

    (41 days)

    Product Code
    MQV
    Regulation Number
    888.3045
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    Applicant Name (Manufacturer) :

    SCIENCE FOR BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOSORB ® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB ® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans. The BIO 1-KIT ® BIOSORB® filled cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with the BIOSORB ® Resorbable Void Filler and deliver the material to the orthopedic surgical site.
    Device Description
    BIOSORB ® bone void filler (BIO1 range of products) (K021963) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βTCP) indicated for Bone Void Filling. BIOSORB ® bone void filler presents a multidirectional interconnected porosity structure (45% and 70%), similar to that of the human cancellous bone. BIOSORB ® bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption within 6-12 months prevents premature resorption and failed filling. The impregnation of bone substitute with marrow is largely practiced by the surgeons. Usually this operation is done by immersion of the bone substitute in a container containing the osseous marrow. In order to facilitate this operation and to limit the contact of the mixture with the ambient air at the origin of the degradation of the cells and proteins contained in osseous marrow, S.B.M has developed a system allowing the and procession of autologous osseous marrow, the impregnation of the calcium phosphate pellets and the impaction of the mixture in the cavity to be filled. This system allows the impregnation of porous pellets with osseous marrow under aseptic conditions. BIO 1-Kit® comprises : - a pre-filled syringe of BIOSORB® (β-ΤCP porous ceramic pellets) - a connector with an adapter and a needle - a bone marrow aspiration needle BIO 1-Kit® is delivered sterile and intended for a single use. BIO 1-Kit® is available either with BIOSORB® granules (1.5 and 3.0 mm in diameter) or BIOSORB® blocks (4x4x4 mm) and in quantities ranging from 5 cc to 45 cc.
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