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Application of therapeutic ultrasound for: · Pain. - · Pain relief, muscle spasms, and joint contractures. - · Relief of pain, muscle spasms, and joint contractures that may be associated with: - o Adhesive capsulitis. - o Bursitis with slight calcification, - o Myositis, - o Soft tissue injuries, and - o Shortened tendons due to past injuries and scar tissues. - · Relief of pain, muscle spasms, and joint contractures resulting from: - o Capsular tightness, and - o Capsular scarring. - · Localized increase in blood flow. - · Increased range of motion of contracted joints using heat and stretch techniques.

The JAS Pulse is a physical medicine ultrasonic diathermy device. The JAS Pulse device consists of a handheld transducer that generates high frequency sound waves. These sound waves penetrate tissue and are used to treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow. The handheld device is intended to be single patient use and is used with ultrasonic gels to facilitate coupling to the patient's skin surface and to enhance ultrasonic penetration. Components of the JAS Pulse device include the handheld electrical control unit with user interface to select treatment power levels and time intervals. The controller drives the handheld treatment applicator to provide continuous and pulsed 1MHz therapeutic ultrasound. Ultrasonic gels applied to the user's area of pain facilitate ultrasonic coupling and penetration to facilitate the therapeutic ultrasound.

The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Ultrasonic System with PLLA Fasteners is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, tendon, and/or bone. Energy applied to the trailing end of the implant portion contacting the handpiece end effector joins this implant portion to the other implant portion in securing soft tissue, ligament, tendon, and bone. Ultrasonic handpieces with end effectors designed to accommodate Unity Implants are product specific and include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.

The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Ultrasonic System is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-laotic acid (PLLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, teadon, and bone at a repair site. An olectrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, rendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management. Modifications are being made to the electrical generator and ultrasonic handpiece components of the ultrasonic system to improve overall system performance and to enhance user interface features. Additionally, the handpiece is being modified to include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.

The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.

The Unity Alpha PLLA System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Alpha PLLA System is designed for the fixation of tissue, ligament, tendon. and bone. Absorbable poly-1.-lactic acid (PLLA) implant materials are ultrasonically welded to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon. and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management.

The TranSet™ System are fixation devices indicated in bone, tissue, ligament, and tendon repair. The system allows for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, and tendon repair. The compression and holding together of bone, tissue, ligament, and tendon fragments of the system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site: - Up to USP Size No. 2 Suture, - Up to USP Size No. 2 High Tensile Suture, - Metallic Cable, and - Metallic Wire.

The TranSet™ System intended use is in the dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system consists of a cannulated drill, a lead button or anchor, a flexible material that runs across a repair site, a metallic crimp, and a manual hand held crimping instrument. The flexible material is tensioned and secured with a metallic crimp by the manual hand held instrument allowing a compressive load to be applied across the repair site. This compression and holding together of the bone, tissue, ligament, and tendon fragments further promotes healing at the repair site. Lead buttons or anchors with a corresponding flexible material are provided sterile for single patient use. Cannulated drills for delivery of the implant materials are single patient use. The reusable crimping instrument and a sterilization tray for autoclaving complete the system.

The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following: Shoulder: Bankart lesion repairs Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis SLAP lesion repairs Elbow, Wrist, & Hand: Scapholunate ligament reconstruction Ulnar collateral ligament reconstruction Radial collateral ligament reconstruction Biceps tendon reattachment Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Foot & Ankle: Medial instability repair/reconstruction Lateral instability repair/reconstruction Achilles instability repair/reconstruction Midfoot reconstruction Hallux valgus reconstruction Pelvis Bladder neck suspension procedures

The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable suture anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The 6.0 mm absorbable suture anchor implant is provided sterile and once passed with suture is inserted into a predrilled bone soft tissue repair site (i.e., rotator cuff repairs) with the use of disposable and reusable introduction devices. The threaded design of the suture anchor implant allows it to be screwed into the bone tissue repair site engaging cancellous bone and acts as an anchor in securing soft tissue to bone.

The TranSet™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet™ Fracture Fixation System. The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.

The TranSet™ Fracture Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical buttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture running across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.

The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.

The Multitak Suture Snap System is designed for approximating and securing soft tissue in arthroscopic and open surgical procedures. The resorbable poly-L securing our assue in tasonically welded to secure suture at the wound repair site and takes the place of tying arthroscopic and open surgical repair knots. The system consists of a generator that provides ultrasonic energy to a handpiece. The energy applied to the handpiece is used to ultrasonically weld a resorbable crimp and secure suture during general tissue wound repair. The resorbable poly-L-lactic acid crimp is gradually degraded into lactic acid and excreted as carbon dioxide and water.

The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures. The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: - Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis - Elbow: Ulnar or radial collateral ligament reconstruction - Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure - Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs

The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.