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510(k) Data Aggregation

    K Number
    K233601
    Device Name
    Fixone Meniscal Repair
    Manufacturer
    Aju Pharm Co., Ltd.
    Date Cleared
    2024-08-02

    (267 days)

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

    Aju Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.
    Device Description
    The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter. The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage. The device is provided sterile for single use only.
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    K Number
    K230892
    Device Name
    Fixone Biocomposite Anchor
    Manufacturer
    Aju Pharm Co., Ltd.
    Date Cleared
    2023-06-09

    (70 days)

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

    Aju Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. The following indications are for the S and SL type anchors only: Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Hip: Capsular repair, Acetabular Labral repair
    Device Description
    The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
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    K Number
    K222423
    Device Name
    Fixone All Suture Anchor
    Manufacturer
    AJU Pharm Co., Ltd.
    Date Cleared
    2023-03-23

    (224 days)

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

    AJU Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
    Device Description
    Fixone All suture anchor consists of one "fix Suture" and one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only. The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively.
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    K Number
    K203523
    Device Name
    Fixone hybrid knotless anchor
    Manufacturer
    AJU Pharm Co., Ltd.
    Date Cleared
    2021-12-25

    (389 days)

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

    AJU Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
    Device Description
    The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 11 models. It provide non-sterile (user must sterilization before use).
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    K Number
    K193497
    Device Name
    Fixone Biocomposite Interference Screw
    Manufacturer
    AJU Pharm Co., Ltd.
    Date Cleared
    2021-01-05

    (385 days)

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

    AJU Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixone Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
    Device Description
    The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 6 models. It provide non-sterile (user must sterilization before use).
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    K Number
    K192484
    Device Name
    Fixone Biocomposite Anchor
    Manufacturer
    AJU Pharm Co., Ltd.
    Date Cleared
    2020-03-11

    (183 days)

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

    AJU Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Posterior Oblique Ligament Repair. lliotibial Band Tenodesis: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
    Device Description
    The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-ΤCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).
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    K Number
    K192032
    Device Name
    Fixone Biocomposite Small Anchor
    Manufacturer
    AJU Pharm Co., Ltd.
    Date Cleared
    2020-03-03

    (217 days)

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

    AJU Pharm Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fixone Biocomposite Small Anchor are intended to be used fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers. Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair
    Device Description
    The Fixone Biocomposite Small Anchor is intended for reattaching soft tissue to bone with sutures. It consists of Driver, Anchor, Non-absorbable suture and needle. A needle was attached to the end of the suture so that it could penetrate the damaged soft tissue to enable it to be used for OPEN surgery without arthroscopy. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A non absorbable suture manufactured from co-braided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
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