Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p53
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 53/696)
Character Range: 1151434–1162501

the implant shaft; 3.) the perforated implant plate. The implant plate can be arranged centrically (round) towards the implant shaft or eccentrically (oval). In the eccentric version (oval), an additional groove has been worked into the plate to improve receiving the malleus handle.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Offset Head with slitted Bell - shaft diam. 0.3mm, Length 0.5 - 3.5mm
                                                                                                                                                                                                                    Variable - The implant body consists of two parts, a shortenable shaft that is firmly bound to the prosthesis bell, and a prosthesis plate that has been provided with a borehole in its underside. The borehole has been dimensionally designed in such a way that it can receive the shaft after the latter has been adapted lengthwise to the respective situation in the middle ear.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Central Head with Complete Bell - shaft diam. 0.3mm, Length 0.5 - 3.5mm
                                                                                                                                                                                                                    The surface of the predefined contact point (upper side of implant plate and inner side of the bell) is roughened in order to facilitate better bonding to the eardrum resp. the stapes head.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Partial Titanium Implant with Separate Head, shaft 0 0.3 mm, Length 5.5-2.5mm (variable)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Partial Titanium Implant with Separate Head, shaft 0 0.3 mm, Length 5.5-2.0mm (variable)
QQ463                                                                                  Stapes Prosheses                                                                                                             For reconstruction of the sound conduction chain between middle ear and inner ear through replacement of the stapes. The body of the implant consists of a columella (which in some product versions can be shortened) and a flat band. The columella is inserted in the opened Vestibulum auris through the trepanated stapes foot-plate. The flat band is placed around the long process of the incus. The implants are available in various versions and materials:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Stapes Prostheses Nitinol/PTFE, 1 piece, sterile, Wire diam: 0.2 mm, PTFE shaft diam: 0.4 & 0.6 mm, Incus diam. small standard, large; length 5.25, 5.50, 5.75, 7.00 (shortenable)                                                                                                                                                                                                                                        $227.00
                                                                                                                                                                                                                    • Titanium: Columella and flat band made of titanium;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Stapes Prostheses Platinum/PTFE, 1 piece, sterile; piston diam. 0.4 & 0.6 mm; length 5.25, 5.50, 5.75, 7.00 (shortenable), 10.00 (shortenable)
                                                                                                                                                                                                                    • Platinum/PTFE: Columella made of polytetrafluoroethylene (PTFE), flat band made of platinum (Pt);                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Stapes Prostheses Titanium, 1 piece, sterile; piston diam. 0.4 & 0.6 mm; length 5.25, 5.50, 5.75, 8.00 (shortenable)
                                                                                                                                                                                                                    • Nitinol/PTFE: Columella made of polytetrafluoroethylene (PTFE), flat band made of nitinol.

     MED-EL IMPLANT SYSTEMS AUSTRALASIA PTY LTD
US033                                                                                  Passive Middle Ear Implant (partial tympanoplasty prosthesis and stapesplasty prosthesis)                                    The MED-EL passive middle ear implant – tympanoplasty and stapesplasty ossicular replacement prostheses are made of titanium with a bendable shaft (and headplate of the tympanoplasty prosthesis). MRI conditional up to 7.0 Tesla                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              mXACT, mCLIP, mCLIP ARC, mXACT PRO - FL 0.75-3.50mm;   mAXIS(Ø 0.4/0.5/0.6 x FL 3.50-5.50mm), mLOOP (Ø 0.4/0.6 x FL 3.50-10.00mm), mZAM (Ø 0.4/0.5/0.6 x FL 3.50-5.50mm), mFIX (Ø 0.4/0.6