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510(k) Data Aggregation

    K Number
    K242865
    Device Name
    Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
    Manufacturer
    Biocomposites Ltd.
    Date Cleared
    2025-06-12

    (265 days)

    Product Code
    KWL, HSD, JWH, KWS, KWY
    Regulation Number
    888.3360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biocomposites Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer's neck in order to increase stability. The spacer is kept "in place" until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed. The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed. The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.
    Device Description
    The Synicem Hip, Knee, and Shoulder Spacers are combination products made from fully formed polymethylmethacrylate (bone cement) with gentamicin. The bone cement is prepared from a powder component and a liquid component. The hip and shoulder spacers contain a stainless steel core of 316L in accordance with ASTM F138. The spacers are temporary implants utilized to maintain the joint space during two-stage revision arthroplasties. The spacer implant is placed as part of the first stage of the two-stage revision when the original prostheses are removed due to joint infection. Once the infection is cleared, the spacers are removed and replaced with a permanent prosthesis as part of the second stage of the revision process. The joint spacers are not intended to be implanted for longer than 6 months. They are a single use device and supplied sterile.
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    K Number
    K141830
    Device Name
    STIMULAN KIT, STIMULAN RAPID CURE
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2015-01-23

    (200 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site. To fill a bone void or defect created by: - . surgery - . a cyst - a tumour . - . osteomyelitis - . traumatic injury
    Device Description
    Stimulan Kit/Stimulan Rapid Cure are indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Stimulan Kit/Stimulan Rapid Cure are biocompatible and may be implanted at an infected site. Stimulan Kit/Stimulan Rapid Cure are presented as a powder and mixing solution which when mixed together form a paste which may be injected, digitally implanted or applied to the mold provided to produce pellets.
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    K Number
    K082381
    Device Name
    GENEX
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2008-11-14

    (87 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis). Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
    Device Description
    Genex® is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process. Genex® is completely resorbed and replaced with bone during the healing process. Genex® is provided sterile for single use only
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    K Number
    K082383
    Device Name
    FORTOSS VITAL
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2008-09-05

    (17 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.
    Device Description
    Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects. The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.
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    K Number
    K073341
    Device Name
    GENEX PUTTY
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2008-07-09

    (224 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis. Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    Genex® Putty is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® Putty is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process. Genex® Putty is completely resorbed and replaced with bone during the healing process.
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    K Number
    K081428
    Device Name
    MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2008-06-20

    (30 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K072127
    Device Name
    DOMINATOR
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2007-08-31

    (29 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dominator TM is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
    Device Description
    Dominator™ is a bioabsorbable device manufactured from a composite mixture of poly-L-lactic acid (PLLA) and calcium phosphate. It may be supplied with sutures with or without pre-attached needles.
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    K Number
    K071952
    Device Name
    GRAFTLOCK SCREW, ST SCREW
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2007-08-14

    (29 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLok™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis). The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. GraftLok™ ST Screw is used to provide suspensary fixation femoral fixation during double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
    Device Description
    The GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screw manufactured from poly L-lactic acid (PLLA).
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    K Number
    K071091
    Device Name
    MODIFICATION TO BILOK SCREW
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2007-05-17

    (29 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The Bilok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The Bilok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
    Device Description
    The Bilok® Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
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    K Number
    K071115
    Device Name
    MODIFICATION TO BILOK ST SCREW
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2007-05-17

    (27 days)

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

    BIOCOMPOSITES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
    Device Description
    The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
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