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The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray. The modifications made to the device that are the subject of this submission are: Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.

The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray. The modifications made to the device that are the subject of this submission are: Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.

The Scandius TriTis Absorbable Tibial Reconstruction System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstructions of the knee.

The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization trav.

The Scandius TriTis ACL Reconstruction System is intended for use for fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee.

The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray.

The Scandius Absorbable ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

The Absorbable ACL Reconstruction System consists of a two piece implant. The femoral implant is designed to maintain the graft block in the femoral tunnel. A screw placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.

The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

The ACL Reconstruction System consists of a two piece implant designed to fixation soft tissue for ACL reconstruction. The graft block secures the soft tissue graft. A fixation pin placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.