TM Resorbable Orthopedic Fixation System Made exclusively from Resorbable Copolymer The Resorbable Orthopedic Mesh Panel and Sheet System
Resorbable fixation that s as easy as 1 LactoSorb Copolymer 82% L-lactic Acid 18% Glycolic Acid 2 Strength profile that supports healing Significant strength retention through 6 8 weeks Completely resorbed in approximately one year Clinically proven with over 20,000 cases Extensive Range of Implants Maximize Surgical Options 1 Modified from: Pietrzak, W.S. et al., Applied Biomaterials, 38(1): 17 24, 1997. 2 Modified from: Rodeo, S.A. et al., JBJS, 75-A(12): 1795 1803, 1993. 2.5mm solid screws 2.8mm solid screws 3.5 solid and cannulated corticle screws 4.0 cannulated screws 1mm and 2mm thick mesh panels 0.5mm and 1.0mm thick sheets 3Easy-to-Use Instruments Air or water activated heat packs Hex-drive screwdriver Easy screw removal, if necessary Drill and tap guides available
General Guidelines for use of the ReUnite Resorbable Mesh Panel & Sheet System Step 1: Select Appropriate Implant Mesh Panel Mesh panels are available in two thicknesses (1.0mm and 2.0mm) and are 75 x 75mm square. Mesh panels are also available with small or large pre-formed countersunk holes. Small holes accommodate both the 2.5 and 2.8mm diameter ReUnite screws. Large holes accommodate both the 3.5mm and 4.0mm diameter ReUnite screws. Figure 1 Sheets Sheets are available in two thicknesses (0.5mm and 1.0mm) and are 50 x 50mm square. The 2.5mm, 2.8mm, 3.5mm, or 4.0mm diameter ReUnite screws can be used (Figure 1). Step 2: Activate Biomet Heat Pack Water Activated Heat Pack Inject 236 cc's of water (8 oz). Shake heat pack and evacuate excess air within the pouch. Water activated heat pack is ready to use immediately (Figure 2a). Figure 2a Air Activated Heat Pack Open packaging, exposing heat pack to air. Shake periodically. Heat pack will reach appropriate temperature in approximately 45 minutes (Figure 2b). Figure 2b
General Guidelines for use of the ReUnite Resorbable Mesh Panel & Sheet System Step 3: Heat Mesh Panel/Sheet Place mesh panel/sheet on uninsulated surface of heat pack. Fold heat pack in half to cover implant. Implant will become malleable in approximately 30 60 seconds (Figure 3). Figure 3 Step 4: Cut Mesh Panel/Sheet to Desired Size Using scissors, or Biomet Heat Loop, cut the mesh panel/sheet to desired size (Figure 4). Note: Implant will cool as it is being cut. It is not necessary for implant to remain warm/malleable while cutting. It is necessary that the implant go through one heating cycle prior to cutting. Figure 4 Step 5: Contour Mesh Panel/Sheet to Desired Shape Reheat implant using Biomet Heat Pack. Upon removal from the heat pack the implant will remain malleable for approximately 10 15 seconds. Adapt implant to desired shape and hold in place while cooling. Once cool, the implant will retain the new shape (Figure 5). Note: Implant can be heated up to three times, if necessary, to obtain desired shape. Figure 5
Step 6: Drill Holes for Screws Insert appropriate drill guide sleeve into guide handle. Drill pilot hole with appropriate drill bit (Figure 6). Figure 6 Screw 2.5mm 2.8mm 3.5mm 4.0mm Drill Bit 2.2mm diameter 2.2mm diameter 3.0mm diameter 3.0mm diameter Step 7: Measure Hole Depth Solid Screws: Use the provided Biomet depth gauge to measure hole depth (Figure 7a). Figure 7a Cannulated Screws: Reference calibrated depth markings on drill bit against proximal end of the drill guide sleeve (Figure 7b). Figure 7b Depth reference
General Guidelines for use of the ReUnite Resorbable Mesh Panel & Sheet System Step 8: Tap Insert appropriate tap guide sleeve into guide handle. Tap the entire length of the screw with the appropriate tap (i.e. 2.5mm tap for 2.5mm screw) (Figure 8). Step 9: Insert Screws Insert hex head of screw into socket of driver. Torque screw into tapped bone hole. When the screw is fully seated, an additional turn of the driver will shear off the hex head, leaving the permanent head intact (Figure 9). Note: If the hex head does not shear off, the Biomet Heat Loop should be used to remove the hex head. Step 10: Screw Removal (if necessary) If screw removal is necessary after the hex head has been removed, the screw can be backed out using the appropriate spanner instrument. This instrument should not be used to further tighten the screw (Figure 10). Figure 8 Figure 9 Depth reference Figure 10 Indications for use: The LactoSorb Panels and Fasteners are used in maintaining the position of bony fragments or morselized bone graft in the Iliac crest autograft procedures. This product is not intended for use in the spine or joint space. This product is not intended for pelvic fracture fixation. Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this or any other system for use on a specific patient. The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for use on a specific patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. Biomet, LactoSorb and ReUnite TM are trademarks of Biomet, Inc.
2.5mm/2.8mm Screw Instrumentation Small Screwdriver 450047 Small Modular Handle 450048 Direct Head Driver 450049 2.2 Sterile Drill Bit 450087 2.5mm Sterile Tap 450102 2.8mm Sterile Tap 450103 Drill Guide 450083 2.2mm Drill Sleeve 450057 2.0/2.5mm Tap Sleeve 450060 2.8mm Tap Sleeve 450061 Depth Gauge 450070 Instrument Case 450078 3.5mm/4.0mm Screw Instrumentation K-Wire 1.4mm 26-351548 0.045 inch K-Wire Sleeve 450044 Guide Handle 450025 3.0mm Solid Sterile Drill Bit 450088 3.0mm Cannulated Sterile Drill Bit 450089 3.0mm Drill Sleeve 450068 3.6mm Cannulated Overdrill 450043 Cannulated Countersink 450041 "T" Tap Handle 450096 Bayonette Tap Handle 450009 3.5mm Cannulated Sterile Tap 450104 4.0mm Cannulated Sterile Tap 450105 3.5mm Tap Sleeve 450038 4.0mm Tap Sleeve 450067 Screwdriver 450071 Spanner Removal Instrument (3.5mm screw) 450040 Spanner Removal Instrument (4.0mm screw) 450011 Depth Gauge 450012 Instrument Case 450085
Ordering Information ReUnite 2.5mm Orthopedic Screws Part Number Length Description 348500 348501 348502 348503 348504 348505 348506 348507 348508 348509 348510 348511 5mm 7mm 9mm 11mm 13mm 15mm 17mm 19mm 21mm 23mm 25mm 27mm Part Number Length Description 348100 348101 348102 348103 348104 348105 348106 348107 348108 348109 348110 348111 Part Number 348662 348663 348672 348673 Part Number 348629 348643 ReUnite 2.8mm Orthopedic Screws 11mm 13mm 15mm 17mm 19mm 21mm 23mm 25mm 27mm 29mm 31mm 33mm ReUnite Mesh Panels Description 1.0 x 75mm Sq Mesh Panel (2.5/2.8 screw) 1.0 x 75mm Sq Mesh Panel (3.5/4.0 screw) 2.0 x 75mm Sq Mesh Panel (2.5/2.8 screw) 2.0 x 75mm Sq Mesh Panel (3.5/4.0 screw) ReUnite Sheets Description 0.5 x 50mm Sq Sheet 1.0 x 50mm Sq Sheet 348163 348165 348167 348169 348171 348173 348175 348177 348179 348181 348183 348185 348187 348389 348191 348193 348162 348164 348166 348168 348170 348172 348174 348176 348178 348180 348182 348184 348186 348188 348190 348192 ReUnite 3.5mm Orthopedic Screws Part Number Length Description 10mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 10mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm ReUnite 4.0mm Orthopedic Cancellous Screws Part Number Length Description 348820 348822 348824 348826 348828 348830 348832 348834 348836 348838 348840 348842 348846 348850 348854 348858 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 42mm 46mm 50mm 54mm 58mm, P.O. Box 587, Warsaw, IN 46581-0587 574.267.6639 2002 Biomet Orthopedics, Inc. All Rights Reserved web site: www.biomet.com email: biomet@biomet.com Y-BMT-724/011502/K