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FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. FlexBand®, FlexPatch®, and FlexBand® Plus are also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

The FlexBand® / FlexPatch® / FlexBand® Plus products are knitted mesh made from ARTELON® fibers. ARTELON® fiber is made of degradable polycaprolactone-based polyurethane urea. The construction permits the mesh to be cut into any desired shape or size without unraveling. FlexBand® Plus devices have suture attached to each end of the knitted mesh strip. The pre-loaded suture is intended to aid in usability in the operating room. The devices are supplied sterile, one product per package in double layer peel pouch packaging.

The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: • Shoulder: Rotator Cuff Repair, Acromioclavicular Sepair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. · Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. · Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, TFCC. · Hip: Acetabular labral repair.

The ATL Anchors are press fit suture anchors designed to secure the implant in bone and provide suture fixation. There are two configurations: with and without an eyelet. The devices are made from PEEK, are provided sterile, and pre-mounted on a single-use driver. The devices are provided with USP 0 ultra-high molecular weight polyethylene (UHMWPE) suture. ATL Anchors are used with Artelon® provided cannulated or solid stainless-steel drill bits. The devices are tapped into a pilot hole using a standard mallet (not provided).

Artelon® FlexBand, FlexPatch, and FlexBand Plus Tissue Reinforcement products are intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Artelon® FlexBand, FlexPatch, and FlexBand Plus are also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Artelon® FlexBand, FlexBand Plus are not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the bone, provide mechanical strength for the tendon repair. Artelon® Tissue Reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

FlexBand™ and FlexBand™ Plus products are a knitted mesh made from ARTELON® fibers. Artelon® fiber is made of polycaprolactone-based polyurethaneurea. The construction permits the mesh to be cut into any desired shape or size without unraveling. The Flexband Plus™ devices have a suture attached to each end of the ARTELON® mesh strips. The pre-loaded suture is intended to improve usability in the operating room. The sutured FlexBand™ Plus is packaged with two commercial (off-the-shelf) stainless steel passing needles. The device is supplied sterile, one product per package, in double layer peel pouch packaging. The FlexBand™ and FlexBand Plus™ devices are available in several sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of 8cm, 16cm, and 34cm for each width.