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The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap. The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

The Smith & Nephew Gynecology Instrument Tray is a stainless steel tray provided with instrument holders, internal compartment and a pin mat. The tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

The Smith & Nephew ENDOBUTTON DIRECT Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL).

The ENDOBUTTON DIRECT is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON DIRECT allows for the device to be endoscopically delivered from a single access point. The harvested graft is looped through the closed portion of the ENDOBUTTON DIRECT and by pulling on a lead suture attached to the top of the ENDOBUTTON DIRECT the construct is moved through the tunnel. The trailing suture located distal to the graft is then used to flip the device into position, lying flat across the tunnel opening on top of the femoral cortex.

The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicylitis repair), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy), Hip (Hip capsule repair, Acetabular labrum 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), 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).

The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. This device is provided sterile, for single use only.

The Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and Iigaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.

The ENDOBUTTON CL is a machined titanium implant assembled with a continuous loop of polyester tape. It is oblong in shape with four holes through which suture is threaded. The polyester loop is preattached to the center holes. The device is designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point. The device is available with premeasured loops of tape ranging from 20mm-50mm to accommodate different graft sizes. The ENDOBUTTON is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. It is oblong in shape with four holes through which suture is threaded. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point.

The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder (Bankhart Repair, 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 instablility repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions), Elbow (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)

Preloaded 5.5/6.5 mm suture anchor manufactured from PEEK (polyaryletherkeone) incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.

The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand Biceps tendon reattachment Lateral epicondylitis repair Ulnar or radial collateral ligament reconstructions Knee Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Hip Hip capsule repair - Acetabular labrum reattachment 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

Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.

The Smith & Nephew KINSA RC Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis

The KINSA RC Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.

The Smith & Nephew EndoButton Direct Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.

The EndoButton Direct is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the EndoButton Direct allows for the device to be endoscopically delivered from a single access point. The device is available in 5-10mm lengths to accommodate different graft sizes.

The Dyonics® line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate. Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site. The 5mm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels. Dyonics Hysterosocpes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The abrasive cleaning agent is provided as an accessory to the Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes and is intended to be used, when required, to clean the outer surfaces thus maintaining optical integrity and allowing the scopes to perform as per their intended uses.

The Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes are used during various minimally invasive endoscopic procedures to illuminate and visualize the surgical site. The submission describes modified cleaning instructions for these devices and an abrasive cleaning agent accessory.