Craniomaxillofacial Surgery O H c c O H H H H c c O H O H c H O c c c H O Catalog Products shown may not be licensed or cleared in all markets. Availability is subject to change without notice. US • CA S O N I C W E L D R X ™: r e s o r b x ® a n d x G A Perfect Choice Two resorbable polymers for osteosynthesis, PDLLA and PLLA:PGA have been well-established in craniomaxillofacial surgery. Plates and mesh comprised of different polymers give the surgeon options to match their preference. n (C3H4O2)n (C3H4O 2)n Resorb x® polymer consists of PDLLA, D-lactide and L-lactide (each 50%). This polymer is open to hydrolysis due to its totally amorphous structure. It loses strength gradually before metabolism. Resorption time observed in ultrasound follow up: 12-30 months.4,7,8 2 x y n [(C3H4O2) x(C2H2O2)y]n Resorb xG consists of 85% PLLA and 15% PGA, creating an amorphous polymer that has a balance of characteristics. The PGA component with PLLA results in higher initial strength, but a faster decrease of both strength and mass by way of hydrolysis and metabolism. Resorption time: approximately 12-14 months.8 Tensile Strength Resorb xG Resorb x® Tensile Strength (N/mm2) 90 80 70 60 50 40 30 20 10 0 0 5 10 Weeks 15 20 25 Resorbable materials maintain the majority of their strength for 8-10 weeks. After the loss of strength, the material will be processed by the body in the Krebs cycle into CO2 and water.11 The chart above compares the tensile strength of Resorb x® and Resorb xG polymers. Complete degradation of the implant will vary depending on the size and location of the implant and the age of the patient. The results of animal studies show that resorbable implants of similar material composition, size, shape, and manufacturing technique will resorb in approximately 12-14 months.8 3 S O N I C W E L D R X ™ : i n d i c at i o n s Indications Indications Contra-indications · Non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. · Not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantitiy or quality of bone. · Non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.* · Not intended for use in the spine. Not intended for load bearing indications unless used in conjunction with traditional rigid fixation.** **U.S.- FDA clearance only, not Health Canada approved. *Resorb x® is not intended for use in the mandible or full-load bearing situations in Canada. 4 Resorb x® is not intended for full load bearing situations in Canada. Indications for cranial use Indications for oral-maxillofacial use · Non-load bearing fracture repair and reconstructive procedures in pediatric and adult populations. · Non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. · Non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in cranial reconstruction. · Non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in oral and maxillofacial reconstruction. Contra-Indications for cranial use Contra-Indications for oral-maxillofacial use · Not intended for high-load regions in the absence of traditional rigid fixation. · Not intended for high-load regions. · Not intended for areas with active or latent infection or patients in a bad general state of health or suffering from metabolic disorders. · Not intended for areas with active or latent infection or patients in a bad general state of health or suffering from metabolic disorders. 5 P R O D U C T R A N G E : S o n i c We l d R x ™ SonicWeld Rx™ II System 52-502-20-04 SonicWeld Rx™ II System, Complete 52-502-21-04 SonicWeld Rx™ II Ultrasonic unit 52-500-23-04 SonicWeld Rx™ II Handpiece, 3 m 52-501-21-04 Standard sonotrode, straight 52-502-01-04 Open-ended Wrench for sonotrode 52-502-21-04 52-500-23-04 52-501-21-04 52-502-01-04 SonicWeld Rx™ II Ultrasonic unit SonicWeld Rx™ II handpiece, 3 m Standard sonotrode, straight Open-ended wrench for sonotrode 6 Explanation of icons Stainless steel Packaging unit Accessories 52-500-24-04 52-501-22-04 52-501-23-04 52-501-24-04 SonicWeld Rx™ II handpiece, 6 m Standard sonotrode, angled Smoothing sonotrode, straight Smoothing sonotrode, angled 7 P R O D U C T R A N G E : S o n i c We l d R x ™ Xcelsior Water Bath Xcelsior water bath 52-400-10-04 52-400-13-04 52-400-14-04 Xcelsior water bath complete Cover hood Water container with frame 8 Explanation of icons Stainless steel Packaging unit Instruments 1 1 ⁄2 1 ⁄1 1 ⁄2 ⁄1 1 ⁄2 52-201-01-07 52-201-02-07 11-180-15-07 Plate-holding instrument Plate-holding forceps, curved Scissors 9 P R O D U C T R A N G E : S o n i c We l d R x ™ Battery Operated Drill 10 50-800-03-07 50-800-02-04 Battery Operated Drill w/o battery pack Battery pack, sterile Explanation of icons Stainless steel for BOS Drill 1 Packaging unit Sterile Twist Drills 1 S L Ø Non-Sterile Core Hole 3 mm 40 mm 1.0 mm 52-610-03-07 Core Hole 4 mm 40 mm 1.0 mm 52-610-04-07 Core Hole 5 mm 40 mm 1.0 mm 52-610-05-07 Core Hole 8 mm 40 mm 1.0 mm 52-610-08-07 Core Hole 3 mm 40 mm 1.6 mm 52-616-03-07 Core Hole 4 mm 40 mm 1.6 mm 52-616-04-07 Ø 1.6 mm Stop S Overall Length L Ø 1 ⁄1 Ø 2.1 mm Core Hole 5 mm 40 mm 1.6 mm 52-616-05-07 52-616-05-71 Core Hole 10 mm 40 mm 1.6 mm 52-616-10-07 52-616-10-71 11 P R O D U C T R A N G E : S o n i c We l d R x ™ Twist Drills Twist drills for 1.6 mm SonicPins Rx Twist Drills 1 1 12 ⁄1 L Ø Non-Sterile Core Hole 5 mm 20.0 mm 1.0 mm 52-509-05-07 Core Hole 5 mm 29.5 mm 1.0 mm 52-512-05-07 Core Hole 3 mm 50.0 mm 1.0 mm 52-510-03-07 Core Hole 4 mm 50.0 mm 1.0 mm 52-510-04-07 Core Hole 5 mm 50.0 mm 1.0 mm 52-510-05-07 Core Hole 6 mm 50.0 mm 1.0 mm 52-510-06-07 Core Hole 7 mm 50.0 mm 1.0 mm 52-510-07-07 Core Hole 8 mm 50.0 mm 1.0 mm 52-510-08-07 Dental attachment Overall Length L Stop S Ø S J-notch attachment Explanation of icons Stainless steel Dental attachment J-notch attachment 1 Packaging unit Sterile Twist drills for 2.1 mm SonicPins Rx Twist Drills 1 ⁄1 Ø 5 mm 20.0 mm 1.6 mm 52-515-05-07 Core Hole 5 mm 29.5 mm 1.6 mm 52-518-05-07 Gliding Hole 10 mm 22.0 mm 2.1 mm 52-522-10-07 Core Hole 3 mm 50.0 mm 1.6 mm 52-516-03-07 Core Hole 4 mm 50.0 mm 1.6 mm 52-516-04-07 Core Hole 5 mm 50.0 mm 1.6 mm 52-516-05-07 Core Hole 6 mm 50.0 mm 1.6 mm 52-516-06-07 Core Hole 8 mm 50.0 mm 1.6 mm 52-516-08-07 52-516-08-71 Core Hole 10 mm 50.0 mm 1.6 mm 52-516-10-07 52-516-10-71 Gliding Hole 35 mm 70.0 mm 2.2 mm 50-022-01-07 Core Hole Overall Length L Ø L Non-Sterile Dental attachment Stop S 1 S J-notch attachment 52-516-05-71 13 P R O D U C T R A N G E : S o n i c We l d R x ™ Implants SonicPins Rx 1.6 mm SonicPins Rx x 1 14 ⁄1 3 ⁄1 Pin length Item No. 4 5 6 7 52-516-24-04 52-516-25-04 52-516-26-04 52-516-27-04 mm mm mm mm 2 Item No. 52-516-54-04 52-516-55-04 52-516-56-04 52-516-57-04 5 Item No. 52-616-24-04 52-616-25-04 20 Explanation of icons x Resorb x® 1 Packaging unit Sterile 2.1 mm SonicPins Rx x 1 ⁄1 3 ⁄1 Pin length Item No. 4 mm 5 mm 7 mm 9 mm 11 mm 13 mm 15 mm 17 mm 52-521-24-04 52-521-25-04 52-521-27-04 52-521-29-04 52-521-31-04 52-521-33-04 52-521-35-04 52-521-37-04 2 Item No. 52-521-54-04 52-521-55-04 52-521-57-04 52-521-59-04 5 Item No. 20 52-621-24-04 52-621-25-04 2.1 mm Endobrow SonicPins Rx x 1 ⁄1 3 Pin length Item No. 4 mm 5 mm 52-641-14-04 52-641-15-04 1 ⁄1 15 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Plates 1 ⁄1 1 52-080-04-04 x 1 x 1 = 0.8 mm 52-075-04-04 ⁄1 1 52-082-04-04 x 1 x 1 = 0.8 mm = 1.0 mm 52-077-04-04 52-877-04-04 ⁄1 52-075-08-04 x 1 = 1.0 mm 1 = 1.0 mm 52-175-04-04 52-175-08-04 1 52-177-04-04 Template 1 1 Template Template 1 1 ⁄1 52-806-22-04 1 52-808-22-04 1 = 0.8 mm Template 16 1 52-076-08-04 x 1 = 1.0 mm x 1 1 = 1.0 mm 52-178-22-04 52-876-08-04 = 0.8 mm = 0.6 mm 52-076-22-04 52-876-22-04 ⁄1 52-178-08-04 Template 1 1 Explanation of icons x Resorb x® Resorb xG Aluminum 1 Packaging unit Plate profile Sterile 1 ⁄1 1 52-085-05-04 x 1 = 1.0 mm ⁄1 1 52-090-06-04 52-890-06-04 x ⁄1 1 52-088-06-04 1 = 1.0 mm x 1 = 1.0 mm 52-185-05-04 Template 52-188-06-04 1 52-190-06-04 1 1 Template Template 17 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Meshes and Templates 1 ⁄1 1 52-303-25-04 x 1 26 x 26 mm = 0.3 mm 52-306-25-04 x 1 x 1 26 x 26 mm = 0.6 mm 52-310-25-04 52-810-25-04 26 x 26 mm = 1.0 mm 18 1 ⁄1 52-313-25-04 1 ⁄1 25 x 25 mm 52-310-51-04 52-810-51-04 Template 52 x 31 mm 1 =1.0 mm x 1 1 Explanation of icons x Resorb x® Resorb xG Titanium 1 Packaging unit Plate profile Sterile 1 1 ⁄1 52-303-50-04 52-803-50-04 x 1 1 ⁄1 52-313-50-04 1 50 x 50 mm Template 51 x 51 mm = 0.3 mm 52-306-50-04 52-806-50-04 x 1 1 51 x 51 mm = 0.6 mm 52-308-50-04 52-808-50-04 x 1 1 51 x 51 mm = 0.8 mm 52-310-50-04 52-810-50-04 x 1 1 51 x 51 mm = 1.0 mm 52-808-55-04 1 51 x 51 mm = 1.5 mm 19 P R O D U C T R A N G E : S o n i c We l d R x ™ and Resorb x® Meshes 1 ⁄1 52-306-12-04 x 1 flexible, 126 x 126 mm = 0.6 mm 52-310-12-04 x 1 flexible, 126 x 126 mm = 1.0 mm 20 Implants Explanation of icons x Resorb x® Resorb xG Titanium 1 Packaging unit Plate profile Sterile 1/ 1 52-314-12-04 52-814-12-04 x 1 1 Sun plate 126 x 126 mm = 1.0 mm 21 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Meshes and Templates b) a) 1 ⁄1 a) 52-803-13-04 1 126 x 126 mm = 0.3 mm 52-306-13-04 52-806-13-04 126 x 126 mm x 1 1 126 x 126 mm = 0.6 mm 52-308-13-04 52-808-13-04 126 x 126 mm = 0.8 mm 22 52-310-13-04 52-810-13-04 x 1 1 = 1.0 mm x 1 1 b) 52-313-12-04 Template 1 Explanation of icons x Resorb x® Resorb xG 1 Packaging unit Plate profile Sterile 1 ⁄1 1 52-310-27-04 29 x 104 mm = 1.0 mm x 1 ⁄1 52-310-31-04 52-810-31-04 x 1 1 31 x 106 mm = 1.0 mm 23 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Meshes and Templates b) a) a) 52-308-11-04 x 1 52-808-11-04 1 11 x 126 mm 11 x 126 mm 52-249-00-04 52-849-00-04 Template 11 x 246 mm Al 1 = 1.0 mm = 0.8 52-310-11-04 52-810-11-04 b) 52-313-11-89 = 1.0 mm x 1 1 11 x 126 mm = 1.0 mm 52-815-11-04 1 11 x 126 mm = 1.5 mm 1 24 ⁄1 1 ⁄1 x 1 1 Explanation of icons x Resorb x® Resorb xG 1 Packaging unit Plate profile Sterile 52-851-00-04 52-311-11-04 1 16 x 251 mm 11 x 249 mm = 0.8 mm = 1.0 mm 52-251-00-04 x 1 x 1 x 1 52-314-31-04 x 1 11 x 310 mm, curved = 1.0 mm 16 x 251 mm = 1.0 mm 52-251-01-04 16 x 251 mm = 1.5 mm 1 ⁄1 1 ⁄1 1 ⁄1 1 ⁄1 25 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Orbital Floor Meshes a) a) 1 b) 1 ⁄1 a) 52-306-23-04 x 52-806-23-04 a) 52-306-30-04 1 52-806-30-04 x Ø 23 mm Ø 30 mm Mesh for orbital floor Mesh for orbital floor 1 Template x 40 x 40 mm Mesh for orbital floor = 0.6 mm b) 52-406-30-04 Template ⁄1 52-306-40-04 1 1 = 0.6 mm b) 52-406-23-04 26 ⁄1 1 = 0.6 mm 1 b) 1 1 Explanation of icons x Resorb x® Resorb xG 1 Packaging unit Plate profile Sterile 52-806-68-04 1 52-806-69-04 Right Left 3D orbital floor 3D orbital floor = 0.6 mm 1/ 1 = 0.6 mm 1 52-890-30-04 1 30 mm 52-890-40-04 1 40 mm Dynamic orbital rim advancement plate 27 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Neuro & Burr Hole Covers Sella recon plates 1/ 1 52-042-23-04 52-842-23-04 x 1 1 20 x 20 mm = 0.3 mm 52-042-24-04 x 1 20 x 20 mm = 0.2 mm Badie plates 1/ 1 52-042-17-04 7 x 13 mm = 0.6 mm 28 x 1 52-042-18-04 5 x 10 mm = 0.6 mm x 1 52-042-19-04 9 x 16 mm = 0.6 mm x 1 Explanation of icons x Resorb x® 1 Packaging unit Plate profile Sterile ø flat 1 ⁄1 1 52-312-12-04 x 1 Ø = 12 mm ⁄1 1 52-312-17-04 x 1 Ø = 17 mm = 1.0 mm ⁄1 1 52-312-22-04 x 1 ⁄1 52-091-06-04 1 x 1 = 1.0 mm Ø = 22 mm = 1.0 mm x = 1.0 mm contoured 1 ⁄1 1 52-312-13-04 x 1 Ø = 12 mm ⁄1 1 52-312-18-04 x 1 Ø = 17 mm = 1.0 mm ⁄1 1 52-312-23-04 x 1 52-092-06-04 = 1.0 mm Ø = 22 mm = 1.0 mm ⁄1 = 1.0 mm slightly contoured 1 ⁄1 1 52-312-14-04 52-812-14-04 Ø = 12 mm = 1.0 mm x 1 1 ⁄1 1 52-312-19-04 52-812-19-04 Ø = 17 mm = 1.0 mm x 1 1 ⁄1 52-312-24-04 52-812-24-04 x 1 1 Ø = 22 mm = 1.0 mm 29 P R O D U C T R A N G E : S o n i c We l d R x ™ and Implants Resorb x® Membranes & Non-Perforated Meshes 1 ⁄1 1 52-301-28-04 x 1 25 x 25 mm ⁄1 52-301-38-04 = 0.1 mm 1 1 50 x 20 mm = 0.1 mm 30 1 x 1 = 0.1 mm ⁄1 52-301-20-04 x 25 x 25 mm x 1 ⁄1 52-302-30-04 50 x 20 mm = 0.2 mm Explanation of icons x Resorb x® Resorb xG 1 Packaging unit Plate profile Sterile 1 ⁄1 1 52-303-28-04 x 1 26 x 26 mm 26 x 26 mm = 0.6 mm 52-303-52-04 x 1 51 x 51 mm = 0.3 mm 52-306-28-04 1 ⁄1 1 52-306-52-04 52-806-52-04 52-310-14-04 x 1 11 x 126 mm = 0.3 mm x ⁄1 = 1.0 mm x 1 52-810-14-04 1 11 x 126 mm 1 =1.0 51 x 51 mm = 0.6 mm 52-310-52-04 52-810-52-04 x 1 1 51 x 51 mm = 1.0 mm 31 P R O D U C T R A N G E : S o n i c We l d R x ™ s t o r a g e s y s t e m Component Trays 55-969-44-04 55-969-46-04 55-962-45-04 Component tray Small parts module Storage rack for clip magazines 55-962-44-04 55-962-43-04 55-963-51-04 Bottom part for twist drills Upper part for sonotrodes and small parts Sliding cover Optional Components Storage Trays and Containers 55-015-30-01 55-969-42-04 Tray for MiniSet container incl. lid Storage tray 277 x 171 x 54 mm (L x W x H) 32 30 x 30 cm Storage Options Option 1 Option 2 Option 3 Option 4 55-969-44-04 Component tray (also compatible with Level One), consisting of: 55-962-44-04 Bottom part for twist drills 55-962-43-04 Upper part for sonotrodes and small parts 55-015-30-01 Tray for MiniSet container includes lid 55-969-46-04 Small parts module 55-015-30-01 Tray for MiniSet container includes lid 55-969-44-04 Component tray (also compatible with Level One), consisting of: 55-962-44-04 Bottom part for twist drills 55-962-43-04 Upper part for sonotrodes and small parts 55-969-42-04 Storage and processing tray, complete, consisting of: 55-964-30-04 Storage tray 30 x 30 cm 55-969-93-04 Silicone mat 55-963-38-04 Lid for storage tray 55-969-46-04 Small parts module 55-969-42-04 Storage and processing tray, complete, consisting of: 55-964-30-04 Storage tray 30 x 30 cm 55-969-93-04 Silicone mat 55-963-38-04 Lid for storage tray 33 INDEX OF ITEM NUMBERS 11 52-306-40-04....................26 52-510-07-07.......................12 52-803-13-04....................22 11-180-15-07......................9 52-306-50-04.....................19 52-510-08-07......................12 52-803-50-04......................19 50 52-306-52-04....................31 52-512-05-07.....................12 52-806-13-04.....................22 50-022-01-07....................13 52-308-11-04...................24 52-515-05-07......................13 52-806-22-04......................16 50-800-02-04.....................10 52-308-13-04....................22 52-516-03-07.....................13 52-806-23-04.......................26 50-800-03-07....................10 52-308-50-04....................19 52-516-04-07....................13 52-806-30-04......................26 52 52-310-11-04.....................24 52-516-05-07....................13 52-806-50-04......................19 52-042-17-04......................28 52-310-12-04.....................20 52-516-05-71......................13 52-806-52-04.......................31 52-042-18-04.......................28 52-310-13-04.....................22 52-516-06-07.......................13 52-806-68-04......................27 52-042-19-04.......................28 52-310-14-04....................31 52-516-08-07.....................13 52-806-69-04......................27 52-042-23-04......................28 52-310-25-04....................18 52-516-08-71....................13 52-808-13-04......................22 52-042-24-04.....................28 52-310-27-04...................22 52-516-10-07.....................13 52-808-22-04......................16 52-075-04-04....................16 52-310-31-04.....................23 52-516-10-71......................13 52-808-50-04.......................19 52-075-08-04......................16 52-310-50-04.....................19 52-516-24-04......................14 52-808-55-04......................19 52-076-08-04.....................16 52-310-51-04.....................18 52-516-25-04.......................14 52-810-13-04......................22 52-076-22-04.....................16 52-310-52-04......................31 52-516-26-04.......................14 52-810-14-04......................31 52-077-04-04....................16 52-311-11-04.....................25 52-516-27-04.......................14 52-810-25-04.......................18 52-080-04-04...................16 52-312-12-04.....................29 52-516-54-04.......................14 52-810-31-04......................23 52-082-04-04.....................16 52-312-13-04.....................29 52-516-55-04.......................14 52-810-50-04......................19 52-085-05-04....................17 52-312-14-04.....................29 52-516-56-04......................14 52-810-51-04.......................18 52-088-06-04......................17 52-312-17-04.....................29 52-516-57-04......................14 52-810-52-04.......................31 52-090-06-04.....................17 52-312-18-04......................29 52-518-05-07.....................13 52-812-14-04.......................29 52-091-06-04......................29 52-312-19-04.....................29 52-521-24-04......................15 52-812-19-04.......................29 52-092-06-04......................29 52-312-22-04.....................29 52-521-25-04.....................15 52-812-24-04......................29 52-175-04-04.....................16 52-312-23-04....................29 52-521-27-04.....................15 52-814-12-04.....................21 52-175-08-04......................16 52-312-24-04.....................29 52-521-29-04....................15 52-842-23-04.......................28 52-177-04-04...................16 52-313-11-89.....................24 52-521-31-04......................15 52-849-00-04.....................24 52-178-08-04...................16 52-313-12-04....................22 52-521-33-04.....................15 52-851-00-04......................25 52-178-22-04....................16 52-313-25-04.....................18 52-521-35-04....................15 52-876-08-04......................16 52-185-05-04...................17 52-313-50-04....................19 52-521-37-04.....................15 52-876-22-04......................16 52-188-06-04.....................17 52-314-12-04...................21 52-521-54-04......................15 52-877-04-04.......................16 52-190-06-04....................17 52-314-31-04....................25 52-521-55-04....................15 52-890-06-04......................17 52-201-01-07.....................9 52-400-10-04......................8 52-521-57-04.....................15 52-890-30-04......................27 52-201-02-07......................9 52-400-13-04.....................8 52-521-59-04....................15 52-890-40-04......................27 52-249-00-04....................24 52-400-14-07.....................8 52-522-10-07.....................13 55 52-251-00-04......................25 52-406-23-04....................26 52-610-03-07.....................11 55-015-30-01..................32, 33 52-251-01-04......................25 52-406-30-04....................26 52-610-04-07.......................11 55-962-43-04..................32, 33 52-301-20-04.....................30 52-500-23-04.....................6 52-610-05-07.......................11 55-962-44-04..................32, 33 52-301-28-04.....................30 52-500-24-04.....................7 52-610-08-07.......................11 55-962-45-04.......................32 52-301-38-04......................30 52-501-21-04.....................6 52-616-03-07.......................11 55-963-38-04......................33 52-302-30-04......................30 52-501-22-04.....................7 52-616-04-07.......................11 55-963-51-04.......................32 52-303-25-04......................18 52-501-23-04.....................7 52-616-04-71.......................11 55-964-30-04.......................33 52-303-28-04....................31 52-501-24-04.....................7 52-616-05-07.......................11 55-969-42-04..................32, 33 52-303-50-04...................19 52-502-01-04......................6 52-616-10-07.......................11 55-969-44-04..................32, 33 52-303-52-04.....................31 52-502-21-04.......................6 52-616-10-71.......................11 55-969-46-04..................32, 33 52-306-12-04.....................20 52-502-20-01.....................6 52-616-24-04.......................14 55-969-93-04.......................33 52-306-13-04.....................22 52-509-05-07.....................12 52-616-25-04.......................14 52-306-23-04.....................26 52-510-03-07.....................12 52-621-24-04.......................15 52-306-25-04.....................18 52-510-04-07.....................12 52-621-25-04.......................15 52-306-28-04.....................31 52-510-05-07......................12 52-641-14-04.......................15 52-306-30-04.....................26 52-510-06-07.......................12 52-641-15-04.......................15 34 REFERENCES 1. Buijs, G. J., et al., Mechanical strength and stiffness of the biodegradable SonicWeld Rx™ osteofixation system. J Oral Maxillofac Surg, 67(4), 2009. S. 782-787 10. Meara, D. J., et al., Fixation of Le Fort I osteotomies with poly-DLlactic acid mesh and ultrasonic welding – a new technique. J Oral Maxillofac Surg, 70(5), 2012, S. 11391144 2. Burger B. W., Use of ultrasound-activated resorbable poly-D, L-lactide pins (SonicPins) and foil panels (Resorb x®) for horizontal bone augmentation of the maxillary and mandibular alveolar ridges. J Oral Maxillofac Surg, 68(7), 2010, S. 1656 -1661 11. Pietrzak W.S., Bioabsorbable polymer applications in musculoskeletal fixation and healing. In: Pietrzak W. S. (ed.), Orthopedic biology and medicine: Musculoskeletal tissue regeneration, biological materials and methods. Totawa: Humana Press, 2008, S. 509-529 3. Cho P. W. J., et al., Biomechanical study of SonicWeld Rx™ pin in cortical bone graft layering technique. J Oral Maxillofac Surg, 69(5), 2011, S. 1519-1524 12. Pilling E., et al., An Experimental study of the biomechanical stability of ultrasound-activated Pinned (SonicWeld Rx™ + Resorb x®) and screwed fixed (Resorb x®) resorbable materials for osteosynthesis in the treatment of simulated craniosynostosis in sheep. Br J Oral Maxillofac Surg, 45(6), 2007, S. 451-456 4. Cristofaro, M. G., et al., A new system of resorbable rigid three-dimensional fixation using ultrasounds (SonicWeld Rx™ + Sonic Pins Rx) adopted in craniofacial trauma-tology: the author’s experience. It J Maxillofac Surg, 20, 2009, S. 4-52 5. Eckelt U., et al., Ultrasound aided pin fixation of biodegradable osteosynthetic materials in cranioplasty for infants with craniosynostosis. J Craniomaxillofac Surg, 35(4-5), 2007, S. 218-221 6. Heidemann W., et al., Degradation of poly(D,L)lactide implants with or without addition of calciumphosphates in vivo. Biomaterials, 22(17), 2001, S. 2371-2381 7. Heidemann W. & Gerlach K. L., Sonographic examinations on the degradation of bioresorbable osteosynthesis materials. Biomed Tech, 46(9), 2001, S. 236-240 13. Pilling, E., et al., An experimental in vivo analysis of the resorption to ultrasound activated pins (SonicWeld Rx™) and standard biodegradable screws (Resorb x®) in sheep. Br J Oral Maxillofac Surg, 45(6), 2007, S. 447-450 14. Reichwein, A., Clinical experiences with resorbable ultrasonic-guided, angle-stable osteosynthesis in the panfacial region. J Oral Maxillofacial Surg, 67(6), 2009, S. 1211-1217 15. Stelnicki, E. J., et al., Use of absorbable poly (D,L) lactic acid plates in cranial-vault remodeling: presentation of the first case and lessons learned about its use. Cleft Palate Craniofac J, 42(4), 2005, S. 333-339 8. Heidemann W, et al., In vivo investigation of the degradation of poly(D,L)lactide and poly(L-lactide-co-glycolide) osteosynthesis material. Mund-, Kiefer- GesichtsChir, 7, 2003, S. 283-288 9. Iglhaut, G., The Minimally Invasive Shell Technique for Bone Augmentation. Oralchirurgie Journal, 9(3), 2009 35 KLS-MARTIN L.P. A company of the KLS Martin Group Mail: P.O. Box 16369 Jacksonville, FL 32245-6369 Office: 11201 Saint Johns Industrial Pkwy S. Jacksonville, FL 32246-7652 Tel. 904.641.7746 · 800.625.1557 Fax 904.641.7378 · www.klsmartinnorthamerica.com KLS Martin Group Karl Leibinger GmbH & Co. KG 78570 Mühlheim · Germany Tel. +49 7463 838-0 info@klsmartin.com Gebrüder Martin GmbH & Co. KG 78532 Tuttlingen · Germany Tel. +49 7461 706-0 info@klsmartin.com Martin Nederland/Marned B.V. 1270 AG Huizen · The Netherlands Tel. +31 35 5234538 nederland@klsmartin.com KLS Martin Representative Office Middle East Dubai, UAE Tel. +971 (50) 248 3819 middleeast@klsmartin.com KLS Martin GmbH + Co. KG 79224 Umkirch · Germany Tel. +49 7665 9802-0 info@klsmartin.com Martin Italia S.r.l. 20059 Vimercate (MB) · Italy Tel. +39 039 6056731 italia@klsmartin.com KLS Martin Australia Pty Limited Artarmon NSW 2064 · Australia Tel. +61 2 9439 5316 australia@klsmartin.com KLS Martin UK Ltd. Reading RG1 3EU · UK Tel. +44 11 89 00 05 70 uk@klsmartin.com Stuckenbrock Medizintechnik GmbH 78532 Tuttlingen · Germany Tel. +49 7461 161114 verwaltung@stuckenbrock.de Gebrüder Martin GmbH & Co. KG Representative Office 121471 Moscow · Russia Tel. +7 499 792-76-19 russia@klsmartin.com KLS Martin Malaysia 10200 Penang · Malaysia Tel. +604 263 2566 malaysia@klsmartin.com Gebrüder Martin GmbH & Co. KG Shanghai Representative Office Shanghai 201203 Tel. +86 21 2898 6611 china@klsmartin.com Rudolf Buck GmbH 78570 Mühlheim · Germany Tel. +49 7463 99516-30 info@klsmartin.com KLS Martin France SARL 68200 Mulhouse · France Tel. +33 3 89513150 france@klsmartin.com Nippon Martin K.K. Osaka 541-0046 · Japan Tel. +81 6 62289075 nippon@klsmartin.com KLS Martin do Brasil Ltda CEP 04.531-011 São Paulo · Brazil Tel. +55 11 3554 2299 brazil@klsmartin.com The information presented in this brochure is intended to demonstrate a KLS-MARTIN® L.P. product. Please refer to the package insert for the full list of indications, contraindications, warnings, precautions, and sterilization information. Always refer to the package insert before using any KLS-MARTIN® L.P. product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. The KLS Martin SonicWeld Rx™ solution is based on the BoneWelding® technology1) protected by the industrial property rights of WoodWelding AG, Switzerland, and has been licensed by this company. 1) “BoneWelding®“ is a registered Swiss trademark. L1 SonicWeldCatalog v4 · 09.2015