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The Adjustable Fixation Device is indicated for soft tissue to bone fixation for: - 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

The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.

Intended Use: The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia. Indications for Use: The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

The Sinus Dilation System with Cannulated Instrument consists of a disposable balloon which is mounted on a reusable cannulated delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic guidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to guide the device to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc.

The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone. The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only. The SpeedLock System also includes associated instruments for implanting the anchor into bone. The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.

The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

The Titan Ti Suture Anchor System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures: - Shoulder· Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy; - Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis; - Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, - Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair; - Hip: Capsular Repair, Acetabular Labral Repair

The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor

The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.

The ArthroCare® Parallax® Contour® Vertebral Augmentation Device – enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

The ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.

The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.

The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs: reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedFix Suture Implant is a bone anchor that facilitates the attachment of tissue to bone. The SpeedFix Suture System consists of an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures. The following device-specific instrumentation is part of this submission: SpeedLock Drill, Bone Drill Bone Hole Locator SpeedLock Drill Guide, Drill Guide

The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.