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510(k) Data Aggregation

    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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    K Number
    K071704
    Device Name
    SLEEVE AND BUTTON SOFT TISSUE DEVICES
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Date Cleared
    2007-09-17

    (88 days)

    Product Code
    MBI, JDR
    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
    The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone 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 ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction Hip Acetabular labral repair In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following: Knee ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction
    Device Description
    The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.
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    K Number
    K070389
    Device Name
    PEEK KNOTLESS ANCHORS
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Date Cleared
    2007-08-09

    (181 days)

    Product Code
    HWC
    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
    Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement The PEEK Knotless Anchors are single-use devices.
    Device Description
    The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.
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    K Number
    K071498
    Device Name
    SUBTALAR IMPLANT
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Date Cleared
    2007-07-31

    (61 days)

    Product Code
    HWC
    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
    The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to: - Symptomatic acquired flat foot treatment in children and adolescents . - Symptomatic congenital flexible flat foot . - Tarsal coalitions when associated with the flatfoot deformity . - Posterior tibial tendon dysfunction with supple feet . - Paralytic flat foot . - Subtalar Instability . - Severely pronated foot .
    Device Description
    The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.
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