Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p276
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 276/696)
Character Range: 10401220–10428361

suture material                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Adjustable loop length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $374.00
MU205                                                                                               Orthobutton CL                                                                                                                  Braided polyethylene continuous loop combined with a titanium plate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  12 - 60 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $374.00

     NeoSurgical Pty Ltd
NY004                                                                                               Sekure-Lock                                                                                                                     Fixation anchor with suture                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          One size only                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $374.00
QQ052                                                                                               Xiros Secure-Loop with Button                                                                                                   The SECURE-LOOP fixation device consists of a sterile and non-absorbable polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used  to pull the graft assembly into place andthen flip the button, allowing ligament  reconstruction to be performedarthroscopically. The SECURE-LOOP has been designed to be implantable using generic ACL guidewire systems and a standard technique. Thesuture meets applicable specifications established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures. The fixation device is made of titanium alloy which meets ISO 5832-3.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             10 mm  15 mm  20 mm  25 mm  30 mm  35 mm  40 mm  45 mm  50 mm  55 mm  60 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            $374.00

     PurePlay Orthopaedics
PJ052                                                                                               Parcus Synd-Ez SS                                                                                                               The Parcus Synd-EZ  is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Includes top hat, suture and button.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           3.2 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $374.00
PJ043                                                                                               Parcus Sydn-EZ                                                                                                                  The Parcus Synd-EZ  is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                3.9 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $374.00
PJ039                                                                                               AcTiFlip Cinch loop                                                                                                             Button fixation recommended for biceps repair both proximal and distal repairs.   With one size two suture                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           12mm  10mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $374.00
PJ035                                                                                               Parcus - GFS II Large and GFS Mini                                                                                              Parcus - GFS Fixation for knee ligament reconstruction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Button Sizes:   3.9mm-4.4mm in width x 12mm-16.5mm in length.  Loop sizes:  12mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $374.00
PJ040                                                                                               AcTiFlip Infinity loop                                                                                                          Button fixation, recommended for proximal and distal tendon and ligament repair.    Comes with one suture and one needle                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             12mm  10mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $374.00

     REVOLUTION SURGICAL PTY. LTD.
QQ804                                                                                               Revolution Surgical AC Button (Preloaded with Suture)                                                                           Titanium adjustable AC Suture Button Fixation Device with non absorbable suture material.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            One Size                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               $374.00
QQ806                                                                                               Revolution Surgical Adjustable Suture Button (Preloaded with suture)                                                            Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        One size only                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $374.00

QQ815                                                                                               Revolution Surgical Multi-function Button (Preloaded with Suture)                                                               Suture Button, a non-bioabsorbable device designed to be used