Document ID: chunk:federal_register_of_legislation:F2025L00198:schedule:1:p279
Version: federal_register_of_legislation:F2025L00198
Segment Type: schedule
Provision Reference: sch 1 (pt 279/706)
Character Range: 937891–941027

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

NY004  Sekure-Lock  Fixation anchor with suture  One size only  $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

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

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

     REVOLUTION SURGICAL PTY. LTD.
QQ815  Revolution Surgical Multi-function Button (Preloaded with Suture)  Suture Button, a non-bioabsorbable device designed to be used for fixation of bone to bone or soft tissue to bone,                    One Size Only  $374.00
                                                                          and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair

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

QQ804  Revolution Surgical AC Button (Preloaded with Suture)  Titanium adjustable AC Suture Button Fixation Device with non absorbable suture material.   One Size  $374.00

QQ812  Revolution Surgical Fixed Suture Button (Preloaded with Suture)  Button fixation device for ACL/PCL reconstruction