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510(k) Data Aggregation

    K Number
    K140908
    Device Name
    JUGGERKNOT MINI SOFT ANCHOR
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2014-10-02

    (176 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in: Maxillofacial For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
    Device Description
    The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
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    K Number
    K122437
    Device Name
    NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2013-10-18

    (434 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
    Device Description
    The WasherLoc™ and No-Profile Screw and Washer Systems include titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 30mm to 70mm are available, with washer sizes in 14mm, 16mm, and 18mm diameters with and without spikes.
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    K Number
    K123485
    Device Name
    JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2013-03-18

    (125 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JuqqerKnotless™ Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows: Shoulder Acromio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs Elbow Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondy/itis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Liqament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction Hip Labral
    Device Description
    The JuggerKnotless™ Soft Anchors consist of a coreless sleeve structure and a knotless construct incorporating ZipLoop™ Technology. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
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    K Number
    K110879
    Device Name
    BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2011-08-19

    (142 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in: Shoulder Bankart repair Foot and Ankle Midfoot Reconstruction, Hallux valgus reconstruction Hand and Wrist Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.
    Device Description
    The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
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    K Number
    K111564
    Device Name
    MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2011-06-16

    (10 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and redwhite zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
    Device Description
    The Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of a size 2-0 polyethylene/polypropylene ZipLoop™ construct with two #5 polyester sleeves. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeves lock against the meniscal tissue, pulling the tear together. The sleeves control the size of the knot ensuring that the anchor does not become too small and pull through the meniscal tissue. The anchors are pre-loaded onto an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. The insertion device is available as an in-line inserter or a pistol-grip inserter, the MaxFire™ MarXmen™ Meniscal Repair Device. This allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the knotted end of the ZipLoop™ construct is gently pulled by the surgeon, allowing the meniscal tear to be compressed. The Maxfire™ anchor sits on the back side of the meniscus.
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    K Number
    K110039
    Device Name
    BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2011-05-03

    (117 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
    Device Description
    The Biomet Sternal Fixation Devices System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension to close the ZipLoop™ construct to the desired size. The Biomet Sternal Fixation System Devices are single use.
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    K Number
    K103145
    Device Name
    HAMMERLOC TM TIBIAL FIXATION DEVICE
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2011-02-09

    (107 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Device Description
    The Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions. The inserter instrument provides a means to apply and hold tension to the soft tissue, align and drive the PEEK implant. A nitinol quide wire instrument is provided to aid in implant placement. The TunneLoc™ Tibial Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.
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    K Number
    K101063
    Device Name
    SLEEVE WITH ZIPLOOP FIXATION DEVICES
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2010-06-23

    (68 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sleeve with ZipLoop™ Fixation Devices are intended for fixation for the following indications: Shoulder Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis Foot and Ankle Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair Elbow Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment Knee Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure Hand and Wrist Collateral ligament repair, Scapholunate reconstruction, Tendon transfers in phalanx, Volar plate reconstruction Hip Acetabular labral repair
    Device Description
    The Sleeve with ZipLoop™ Fixation Devices are a three component assembly consisting of two sleeves and a ZipLoop™ construct. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop is pulled tight, the sleeve locks against the bone fixating the soft tissue. The Sleeve with ZipLoop™ Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.
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    K Number
    K083070
    Device Name
    TOGGLELOC SYSTEM
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2008-12-16

    (62 days)

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

    BIOMET SPORTS MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications: Shoulder: Bankart lesion repairs Acromio-clavicular repair, Capsular shift/capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with Tophat) Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment Knee: ACL/PCL repair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx. Volar plate reconstruction Hip: Acetabular labral repair
    Device Description
    The ToggleLoc™ System contains toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs. The suture button has multiple eyelets for attachment of fiber constructs and/or sutures. The fiber constructs and/or sutures are preloaded for the convenience of the surgeon for soft tissue attachment.
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    K Number
    K071816
    Device Name
    HARPOON SUTURE ANCHOR
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Date Cleared
    2007-09-20

    (80 days)

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

    BIOMET SPORTS MEDICINE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are: Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair Wrist - Scapholunate ligament reconstruction Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction Hip - Capsular Repair (acetabular labral repair)
    Device Description
    The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.
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