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510(k) Data Aggregation

    K Number
    K231033
    Device Name
    CEPTRE® Knotted UHMWPE Suture PEEK Anchor
    Date Cleared
    2024-01-04

    (268 days)

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

    Healthium Medtech Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications: - 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction. - 2. Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy. - 3. Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis. - 4. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral 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. - 5. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair. - 6. Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.
    Device Description
    The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.
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    K Number
    K230891
    Device Name
    SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
    Date Cleared
    2023-12-28

    (272 days)

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

    Healthium Medtech Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.
    Device Description
    The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.
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    K Number
    K232886
    Device Name
    INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
    Date Cleared
    2023-11-08

    (51 days)

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

    Healthium Medtech Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).
    Device Description
    The use of the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgery of soft tissue to bone fixation. The fixation device allows for arthroscopic ligament reconstruction approaches.
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    K Number
    K231404
    Device Name
    T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
    Date Cleared
    2023-08-04

    (81 days)

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

    Healthium Medtech Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction.
    Device Description
    The T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is a permanently implantable Polyether Ether Ketone (PEEK) cortical tibial suspension fixation device which provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgeries and repair. The fixation device allows for endoscopic or open ligament reconstruction approaches. The Closed button is preloaded with UHMWPE adjustable loop and in Open Button the UHMWPE adjustable loop is non preloaded.
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    K Number
    K223889
    Device Name
    Stativ® Knotted UHMWPE Suture Anchor
    Date Cleared
    2023-03-22

    (85 days)

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

    Healthium Medtech Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures: 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. 2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction. 3. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. 4. Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). 5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction. 6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.
    Device Description
    The STATIV® Knotted UHMWPE Suture Anchor is a fixation device intended to provide secure fixation of soft tissue to bone and is available in self-tap/self-punching variant also. It consists of a soft Suture Anchor with attached non-absorbable suture(s) to an inserter with handle. The Anchor are available in various sizes, preloaded with suture, tape or suture-tape combinations. This device is provided sterile, for single use only.
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