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The Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications: - Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/ tendon repairs/ reconstructions Bunionectomy Knee Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis Hip Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

The Dunamis PunchTac Suture Anchors is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components: - Suture Anchor (threaded, push-in and knotless designs) - . USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene Suture(s) or Suture Tape (provided in configurations with suture only) - . Inserter Tool

The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone. The components are intended to serve as fixation posts, a distributing suture tension over areas of ligament or tendon repair. Specifically, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.

The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The Dunamis Fixation System consists of titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports.

The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder (Capsular Stabilization - Bankart Repair, - Anterior Shoulder Instability, - SLAP lesion repairs, - Capsular Shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid Repairs, Rotator Cuff tear repairs, Biceps tenodesis), Elbow, Wrist, and Hand (Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: - medial collateral ligament, - lateral collateral ligament, - posterior oblique ligament, Patellar realignment and tendon repairs: - vastus medialis obliquous advancement, Iliotibial band tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instablility repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy).

The Dunamis Suture Anchor is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components: Suture Anchor, Teleflex Force Fiber Suture(s), USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene, Inserter tool. The Dunamis Suture Anchor is packaged ready to use condition and provides aseptic O.R delivery. The system is provided complete and is not intended to be used or integrated with other bone anchor fixation implantable devices.

The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".

The Dunamis Force DFX Tensile Tape Sutures are sterile single use sutures used in approximation and/or ligation of soft tissues, including use in allograft tissue for orthopaedic surgeries. Force DFX Tensile Tape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force DFX Tensile Tape suture is flat in shape and differs from USP requirements (not USP). It is available in 1.5mm, 2mm, tape width sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE). Force DFX Tensile Tape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.

The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameters of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee (ACL Repairs, PCL Repairs, Extra-capsular repairs - Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization - Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus (FLH), Tendon Transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Reconstruction).

Reattachment of ligament, tendon, soft tissue, or bone, shoulder, foot, ankle, knee, elbow and hand/wrist.

The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries

The Dunamis Force DFX Sutures are sterile single use sutures are used in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries. The technical design configuration for both USP Size 2 and Size 5 are as follows: USP Size 2 (metric 5) White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 2 (oversized) x 36" length, single armed HC-5 needle. Packaged 1(one) strand per pouch, 12 pouches per box, sterile. USP Size 5 (metric 7) White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 5 (oversized) x 36" length, single armed HS48 needle. Packaged 1(one) strand per pouch, 12 pouches per box, sterile Materials: Co-Braid of UHMWPE and Blue Monofilament Polypropylene Non-absorbable Surgical Sutures meets USP requirements except for diameter. Polymer/Colorant: Ultra High Molecular Weight Polyethylene (white): None Polypropylene (blue): [bhthalocyaninato (2-)] copper with a concentration not to exceed 0.5% by weight.