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balanSys REV – Extension Gap First: 3in1 –

Indications and contraindications

Indications

• Painful and / or disabling joint disease of the knee resulting from osteoarthritis,

avascular necrosis, inflammatory arthritis or posttraumatic arthritis

• Failure of previous surgery or medical device including knee arthroplasty

Contraindications

• Local or general infection
• Any soft tissue, ligament, nerve or vessel insufficiency which may create

an unacceptable risk of prosthesis instability, prosthesis fixation failure and / or
complications in post-operative care

• Compromised bone stock due to bone loss or bone defects and / or

insufficient bone substance, which cannot provide adequate support and / or
fixation for the prosthesis

•  Hypersensitivity to materials used
•  Skeletal immaturity
•  Genu recurvatum
•  Insufficiency of the extensor mechanism
•  Progressive neoplastic disease

For further information, please refer to the instructions for use or ask your Mathys representative.

Содержание balanSys REV

Страница 1: ...technique balanSys REV Extension Gap First 3in1 For healthcare professional use only The illustrated image does not represent a connection between the use of the medical device described nor its perf...

Страница 2: ...Mathys is committed to this guiding principle and pursues a product portfolio with the goal of further developing traditional philosophies with respect to materials or design in order to address exis...

Страница 3: ...bly 51 Implantation 55 Appendix 58 1 Size compatibility of the balanSys REV Implants 59 2 Optional combination with balanSys BICONDYLAR 60 3 Item numbers of the balanSys REV Implants 62 4 Packaging of...

Страница 4: ...to balanSys PS CR UC Inlays for complex primary TKA 5 sizes 64 70 75 80 85 Variability balanSys REV Stem Identical stems for tibia and femur With morse taper connection Straight and 4mm offset 12 dia...

Страница 5: ...ment nerve or vessel insufficiency which may create an unacceptable risk of prosthesis instability prosthesis fixation failure and or complications in post operative care Compromised bone stock due to...

Страница 6: ...ate BICON DYLAR Femur Furthermore the REV femur implants can be used in combination with a BICONDYLAR PS inlay Refer to appendix 2 for a detailed description of combina tion possibilities Additional i...

Страница 7: ...ther intramedullary alignment can be performed If bone defects exist preoperatively the surgeon performing the procedure must understand the implications of this bone loss as well as the tech niques r...

Страница 8: ...previous incisions stiffness or a fibrotic soft tissue envelope Usually greater exposure is required for a revision total knee arthroplasty as compared with that of a primary TKA Proper tissue planes...

Страница 9: ...e tibial component Excessive force to remove the components can lead to femoral fracture or extensive bone loss In case the patella was resurfaced previously with a balanSys Patella special atten tion...

Страница 10: ...below the refresh cut when the reamer is in the final posi tion In a primary situation the markings should be app 8mm below the surface Remark Be very careful when reaming The balanSys Reamers are sh...

Страница 11: ...est over the shaft until it reaches the level of the tibial osteotomy only required for the 140 and 200mm reamers Use the Positioning Fork 79 02 0029 to hold down the Guide Sleeve The Tibial Reference...

Страница 12: ...raight The holes should be pre drilled with the Drill Bit 315 310 Remark Tibia shaft axis is orientated 90 to tibia plateau 0 posterior slope Hence rotational alignment does not influence the slope or...

Страница 13: ...ation might be nec essary Insert the Tibial Cutting Guide 79 02 0290 again into the Aiming Device Proximal Depending on the thickness 5 or 10mm the correct slot needs to be chosen 1st Slot 5mm below s...

Страница 14: ...the Memory Board 79 02 0637 to record the necessary augmentation in this example REV Tibial Augmentation LL RM 5mm If the medial and lateral augments have different heights use a saw or chisel in ord...

Страница 15: ...nto the Tibial Template 79 02 0291 to 79 02 0295 Remark Scale can be read by the operator 12 o clock poste rior Insert the last used Reamer and check the depths The marking must be at least equal with...

Страница 16: ...In this example the 4mm Offset Tibial Guide 79 02 0543 is used Use the Memory Board 79 02 0637 to record the required offset in this example a 4mm offset is re quired Special attention must be given t...

Страница 17: ...rotation in this example 9 o clock Fix the Tibial Template with 4 Pins 71 02 3054 Remove all of the following instruments 1 Offset Tibial Guide 79 02 0541 or 79 02 0543 2 Offset Graduated Collar 79 02...

Страница 18: ...Plateau Size markings are etched onto the Reamer marking must be flush with the end of the Reamer Guide After completing the preparation for the anchorage stem the PS Reamer and the Reamer Guide must...

Страница 19: ...size of the Tibial Template Remove all remaining instruments except the Pins This steps are required if no or only one augmentation is selected Guide the Tibia Reamer 10 79 02 0279 over the Pins and...

Страница 20: ...e Remark The orientation of the Test Stem Core is correct when it can no longer be rotated The laser marking is orien tated towards the Reference Plate Position the Trial Tibial Plateau 79 02 0060 to...

Страница 21: ...w Positioner 79 02 0270 and insert the screw into the hole but do not tighten it yet Rotate the Offset Alignment Disk 79 02 0287 until the Reference Plate 77 02 0031 corresponds with the predetermined...

Страница 22: ...e the Trial Stem Sleeve insert a Pin through the hole at the distal end and turn in the appropriate direction Click the Test Augmentations onto the lower surface of the Trial Tibial Plateau Remark The...

Страница 23: ...ional stability if using medial and lateral Augmentations Open the screw and remove the Positioner Remark Leaving the test assembly in place during the femur preparation is recommended In case of usin...

Страница 24: ...Check if the assessed femur size is compatible with the determined tibia size Appendix 1 Size Compatibility of the balanSys REV Implants Remark The Medical advisors recommend using a larger size if in...

Страница 25: ...kings should be just below the refresh cut when the reamer is in the final posi tion In a primary situation the markings should be app 12mm below the joint line Slide the Guide Sleeve 79 02 0510 to 79...

Страница 26: ...al cutting block of the 3in1 system 71 34 0682 onto the reamer using the distal cutting block guide of the 3in1 system 71 34 0683 and the clamp lever 71 34 0684V of the 3in1 system and the screw of th...

Страница 27: ...distal condyles in those cases in which the native bone is still present and no resections have been carried out yet primary case Saw blade slot marked 0 for revisions those cases in which an primary...

Страница 28: ...o make this adjustment loosen the screw holding the distal cutting block of the 3in1 system in place by turning the knob Now secure the distal cutting block of the 3in1 system to the femur with at lea...

Страница 29: ...at have to be compensated for by means of augmentation choose the appropri ate saw blade slot Remark If permissible on the basis of the bone quality and if pin fixation is sufficient the connection to...

Страница 30: ...ss of the inlay using the trial inlay for the spacer 79 02 0730 to 79 02 736 and the size 12 femoral spacer block 79 02 0652 In case of using a balanSys BICONDYLAR PS Tibia the tibial resection may be...

Страница 31: ...right knee the R mark on the guide sleeve must correspond to the Right mark on the cutting block In the case of an offset stem introduce the size 4 fe mur offset guide 71 34 0652 into the offset sleev...

Страница 32: ...be possible to turn the femur offset guide Slide the assembled combination cutting block of the 3in1 system plus the offset sleeve insert and the offset guide onto the shaft of the reamer Then push th...

Страница 33: ...d if no offset is re quired this step is superfluous Turning the femur offset guide will also cause the AP position to change and this has an impact on the flexion gap All adjust ments also affect the...

Страница 34: ...ral spacer block 79 02 0652 If the ligament tension is too taut choose a smaller femoral component if possible If the ligament tension is too lax choose a larger femoral component if possible To deter...

Страница 35: ...part of the cutting block of the 3in1 system Now carry out the femur cuts in the following order anterior posterior anterior chamfer cut Description of the inferior cutting surfaces of the AP cutting...

Страница 36: ...or the posterior condyles Saw blade slot marked 10 for a 10mm augmentation Saw blade slot marked 5 for a 5mm augmentation Saw blade slot marked 0 for revisions cases in which an original prosthesis wa...

Страница 37: ...ase of the stem to be reamed the cutting block of the 3in1 system must be fitted back onto the straight pins so that it will be placed in exactly the same position again The cutting block of the 3in1...

Страница 38: ...en Remark The orientation of the Test Stem Core is correct when it can not be rotated any more The laser marking is orientated towards the Reference Plate Click the Test Augmentations onto the Trial F...

Страница 39: ...Trial Femur The cam of the box should face towards posterior The surface of the Trial Femur and the Femur Box Inlay must align smoothly Assemble the Offset Alignment Disk 79 02 0287 and the Box Adapt...

Страница 40: ...ition The 12 o clock position must face to wards anterior Snap in the Trial Stem Screw 79 02 0071 onto the Screw Positioner 79 02 0270 and insert the screw into the hole but do not tighten it yet Rota...

Страница 41: ...ig 86 In this example the 3 o clock position was measured Remove the Offset Alignment Disk Tighten the Trial Stem Screw with the Hexagonal Screwdriver 314 270 Put the appropriate Trial Stem Sleeve pre...

Страница 42: ...al Stem Sleeve insert a Pin through the hole at the distal end and turn in the appropriate direction Take the femur box inlay 79 02 0470 to 79 02 0474 out again The box has not been prepared yet Inser...

Страница 43: ...ser marking It is advisable to use a narrow saw blade guiding it along the sagittal surfaces of the trial femur When the pins are touched the resection will be stopped Then carry out the transverse re...

Страница 44: ...hang and osteophytes with the Osteophyte Chisel 71 02 3007 Depending on ligament stability a REV Trial Inlay or a PS Trial Inlay can be used Remark It might be advisable to ventralize the tibia as muc...

Страница 45: ...r form the patellar osteotomy and to position the pa tellar trial component before the knee is tested With all the trial revision components in place the knee is tested with respect to range of motion...

Страница 46: ...off 4 uncemented Position the chosen balanSys REV Tibial Plateau onto the Assembly Device reverse side Unpack the chosen balanSys REV Augmentations and screw the implants to the lower surface of the...

Страница 47: ...al end of the chosen balanSys REV Stem into it Tighten the fixation screw of the black Assembly Device Remark There is a marking on the stem this marking must be orientated towards the Reference Plate...

Страница 48: ...strument consists of 3 parts Positioner Handle 79 02 0301 Positioner Rod 79 02 0302 Sizing Ring Positioner 79 02 0303 The necessity to use and the side of the Sizing Ring Positioner is defined by the...

Страница 49: ...e and snap the Positioner Rod through the hole Insert the Positioner Rod with the thread into the opening of the tibial plateau and turn the positioner device in a clockwise direction The threads of t...

Страница 50: ...usage of CR UC or PS Inlays In case of using balanSys BICONDYLAR CR UC or PS Inlays the positioner must be removed and the stem screw must be used Tighten the stem screw with the Torque Wrench 18 410...

Страница 51: ...and lateral balanSys REV Femur Augmentation C 5 dorsal Position the chosen balanSys REV Femur onto the Fe mur Assembly Block 79 02 0540 Unpack the chosen balanSys REV Augmentations and screw the impla...

Страница 52: ...the Assembly Device Insert the Reference Plate 77 02 0031 in the slot of the black Assembly Device and insert the distal end of the chosen balan Sys REV Stem into it Tighten the fixation screw of the...

Страница 53: ...ition The 12 o clock position must face to wards anterior Use the Offset Alignment Disk to set the measured rotation Insert the stem screw onto the Screw Positioner 79 02 0270 and insert the screw int...

Страница 54: ...ew with the Hexagonal Screw driver 314 270 Remove the Offset Alignment Disk 79 02 0287 Use the Femoral Impactor 71 34 0699 to hit the femur only once Tighten the stem screw with the Torque Wrench 18 4...

Страница 55: ...mmer Remove excess cement carefully In case of using a balanSys BICONDYLAR Inlay remove the Positioner after implanta tion and re tighten the stem screw with the Torque Wrench 18 410 RAL5002 with 2 cl...

Страница 56: ...al Inlay may be inserted during the hardening of the bone ce ment After hardening the Trial Inlay must be re moved Afterwards the correct balanSys REV Inlay must be inserted Insert the stabilization s...

Страница 57: ...f the component with the Torque Wrench 3 5 with 2 clicks while counteracting thetorquewiththeNeckStopperCurved 79 02 0750 After implantation the stem screw must be re tightened with the Torque Wrench...

Страница 58: ...with balanSys BICONDYLAR PS Inlay 60 2 3 Optional combination balanSys REV Tibia with balanSys BICONDYLAR Inlays 61 3 Item numbers of the balanSys REV Implants 62 4 Packaging of screws for the balanS...

Страница 59: ...sides femoral and tibial balanSys REV Femur with REV Inlay and Tibia The balanSys REV Inlay cannot be used in combination with any balanSys BICONDYLAR Femur or Tibia balanSys REV Inlays may only be u...

Страница 60: ...REV Femur can be used in combination with the balanSys BICONDYLAR PS Inlay PE or vita mys balanSys REV Femurs must not be used in combination with balanSys BICONDYLAR CR UC or RP Inlays balanSys REV...

Страница 61: ...d in combination with balanSys REV Femurs and balanSys REV Tibias 2 3 Optional combination balanSys REV Tibia with balanSys BICONDYLAR Inlays Remark balanSys BICONDYLAR CR and PS Femurs of size XS can...

Страница 62: ...rMo balanSys REV Femur Augmentation distal Item no Size Item no Size 79 15 0221 A 5 79 15 0242 C 10 79 15 0222 A 10 79 15 0251 D 5 79 15 0231 B 5 79 15 0252 D 10 79 15 0232 B 10 79 15 0261 E 5 79 15 0...

Страница 63: ...13mm 79 30 0106 64mm 23mm 79 30 0133 80mm 15 5mm 79 30 0111 70mm 10 5mm 79 30 0134 80mm 18mm 79 30 0112 70mm 13mm 79 30 0135 80mm 20 5mm 79 30 0113 70mm 15 5mm 79 30 0136 80mm 23mm 79 30 0114 70mm 18...

Страница 64: ...70 5 LL RM 79 15 0184 80 10 LL RM 79 15 0163 70 10 LM RL 79 15 0191 85 5 LM RL 79 15 0164 70 10 LL RM 79 15 0192 85 5 LL RM 79 15 0171 75 5 LM RL 79 15 0193 85 10 LM RL 79 15 0172 75 5 LL RM 79 15 019...

Страница 65: ...79 15 0088 17mm 140mm 79 15 0083 12mm 140mm 79 15 0089 18mm 140mm 79 15 0084 13mm 140mm 79 15 0090 20mm 140mm 79 15 0085 14mm 140mm 79 15 0091 22mm 140mm 79 15 0086 15mm 140mm 79 15 0092 24mm 140mm Ma...

Страница 66: ...79 15 0138 17mm 140mm 79 15 0133 12mm 140mm 79 15 0139 18mm 140mm 79 15 0134 13mm 140mm 79 15 0140 20mm 140mm 79 15 0135 14mm 140mm 79 15 0141 22mm 140mm 79 15 0136 15mm 140mm 79 15 0142 24mm 140mm Ma...

Страница 67: ...FLAT components Item no Diameter 72 34 0049 26mm 72 34 0050 28mm 72 34 0051 31mm 72 34 0052 34mm 72 34 0053 37mm Material UHMWPE FeCrNiMoMn Contrast balls balanSys 3 Peg Patella components Item no Dia...

Страница 68: ...ouch 1 Stems Description Qty Packed with 1 Stem Screw The screw is partially screwed onto the stem In case of use of a REV Inlay this Stem Screw must be discarded since the fixation is achieved with t...

Страница 69: ...8 balanSys REV Tray Basic No 2 page 70 balanSys REV Tray Basic No 3 with Insert page 72 74 balanSys REV Tray Basic No 4 page 76 The Set Number is 71 34 0740A it consists of the following 7 Trays and t...

Страница 70: ...with Insert page 84 87 Before each surgery instruments should be checked for damage or deformation Use only undamaged instruments Do not use trial components with marks or scratches balanSys REV inst...

Страница 71: ...balanSys REV Extension Gap First 3in1 71 Basic No 1 No Picture 71 34 0042 balanSys REV Lid Basic No 1 balanSys REV 3in1 Instrumentation Set 71 34 0740A 71 34 0041 balanSys REV Tray Basic No 1...

Страница 72: ...mur 12 1 Item no Description Qty 79 02 0660 balanSys REV Spacer block agm L 5 2 79 02 0661 balanSys REV Spacer block agm R 5 2 79 02 0662 balanSys REV Spacer block agm L 10 2 79 02 0663 balanSys REV S...

Страница 73: ...balanSys REV Extension Gap First 3in1 73 Basic No 2 No Picture 71 34 0047 balanSys REV Lid Basic No 2 71 34 0046 balanSys REV Tray Basic No 2...

Страница 74: ...79 02 0325 balanSys REV reamer 25 1 Item no Description Qty 79 02 0510 balanSys REV Guide sleeve 10 1 79 02 0511 balanSys REV Guide sleeve 11 1 79 02 0512 balanSys REV Guide sleeve 12 1 79 02 0513 ba...

Страница 75: ...balanSys REV Extension Gap First 3in1 75 Basic No 3 No Picture 71 34 0053 balanSys REV Lid Basic No 3 71 34 0051 balanSys REV Tray Basic No 3...

Страница 76: ...balanSys REV Trial stem sleeve 13 140 1 79 02 0694 balanSys REV Trial stem sleeve 14 140 1 79 02 0695 balanSys REV Trial stem sleeve 15 140 1 79 02 0696 balanSys REV Trial stem sleeve 16 140 1 79 02 0...

Страница 77: ...02 0021 balanSys PS machine coupling f reamer 1 Item no Description Qty 18 410 RAL5002 Torque wrench 1 Item no Description Qty 71 02 3054 balanSys pin 3 2 80 4 Item no Description Qty 79 02 0281 balan...

Страница 78: ...no Description Qty 71 02 3016 balanSys femur holder 1 Item no Description Qty 71 34 0699 balanSys femoral impactor 1 Item no Description Qty 71 34 0698 balanSys tibial impactor 1 Item no Description...

Страница 79: ...70 04 0109 balanSys alignment rod centre piece 1 Item no Description Qty 70 04 0110 balanSys alignment rod short 1 Item no Description Qty 70 04 0111 balanSys alignment rod long 1 Item no Description...

Страница 80: ...y 71 02 3042 balanSys Trs intramedullary rod 1 Item no Description Qty 71 02 3054 balanSys pin 3 2 80 10 Item no Description Qty 77 02 0031 balanSys reference plate 1 3 2 Item no Description Qty 71 02...

Страница 81: ...Description Qty 77 02 0019 balanSys Trs screw 1 Item no Description Qty 77 02 0041 balanSys Trs connecting screw 1 Item no Description Qty 77 02 0043 balanSys Trs locking bolt 1 Item no Description Qt...

Страница 82: ...Item no Description Qty 79 02 0286 balanSys PS reamer guide 1 Item no Description Qty 71 34 0700 balanSys handle for tib cutting chisel 1 Item no Description Qty 71 34 0240 balanSys positioner for tib...

Страница 83: ...Sys REV Tibial Template 80 1 79 02 0295 balanSys REV Tibial Template 85 1 Item no Description Qty 79 02 0279 balanSys REV Tibia reamer 10 1 Item no Description Qty 79 02 0541 balanSys REV offset tibia...

Страница 84: ...l tibia agm 70 10 LL RM 1 79 02 0172 balanSys REV trial tibia agm 75 5 LM RL 1 79 02 0173 balanSys REV trial tibia agm 75 5 LL RM 1 79 02 0174 balanSys REV trial tibia agm 75 10 LM RL 1 79 02 0175 bal...

Страница 85: ...1 79 02 0331 balanSys REV trial femur A left 1 79 02 0332 balanSys REV trial femur B right 1 79 02 0333 balanSys REV trial femur B left 1 79 02 0334 balanSys REV trial femur C right 1 79 02 0335 balan...

Страница 86: ...istal trial agm femur C 10 2 79 02 0451 balanSys REV distal trial agm femur D 5 2 79 02 0452 balanSys REV distal trial agm femur D 10 2 79 02 0461 balanSys REV distal trial agm femur E 5 2 79 02 0462...

Страница 87: ...nSys REV Neck stopper straight 1 Item no Description Qty 79 02 0288 balanSys REV box adapter 1 Item no Description Qty 79 02 0301 balanSys REV positioner handle 1 Item no Description Qty 79 02 0302 ba...

Страница 88: ...w large 1 Item no Description Qty 71 34 0651 balanSys REV 3in1 Femur offset guide 0 1 Item no Description Qty 71 34 0652 balanSys REV 3in1 Femur offset guide 4 1 Item no Description Qty 71 34 0655 bal...

Страница 89: ...10 2 71 34 0674 balanSys REV 3in1 Augmentation C 5 2 71 34 0675 balanSys REV 3in1 Augmentation C 10 2 71 34 0676 balanSys REV 3in1 Augmentation D 5 2 71 34 0677 balanSys REV 3in1 Augmentation D 10 2...

Страница 90: ...ial inlay 64 23 1 79 02 0361 balanSys REV PE trial inlay 70 10 5 1 79 02 0362 balanSys REV PE trial inlay 70 13 1 79 02 0363 balanSys REV PE trial inlay 70 15 5 1 79 02 0364 balanSys REV PE trial inla...

Страница 91: ...balanSys REV PE trial inlay 80 18 1 79 02 0385 balanSys REV PE trial inlay 80 20 5 1 79 02 0386 balanSys REV PE trial inlay 80 23 1 79 02 0391 balanSys REV PE trial inlay 85 10 5 1 79 02 0392 balanSy...

Страница 92: ...rgery The balanSys REV Instrument Set includes 2 Memory Boards The idea is to use one in the sterile area to record and to transfer the information to the one in the non sterile area The non sterile o...

Страница 93: ...1 644 Fax 41 32 644 1 161 www mathysmedical com Measuring template balanSys REVISION Tibia Item no 330 030 026_B 02 1110 04 2010 11 Mathys Ltd Bettlach Tibia Size 64 for Femur Size A B Augmentation P...

Страница 94: ...nnecting screw 77 02 0041 7 7 Insert the Tibial Cutting Guide 79 02 0290 8 onto the Aiming Device Proximal 71 02 3032 6 8 Set the REV Tibial Cutting Guide 79 02 0290 8 to zero and tighten the screw 9...

Страница 95: ...balanSys REV Extension Gap First 3in1 95 Manufacturer Caution Symbols...

Страница 96: ...sdorf 07646 M rsdorf Th r Tel 49 364 284 94 0 info de mathysmedical com Centre of Excellence Production Hermsdorf 07629 Hermsdorf Tel 49 364 284 94 110 info de mathysmedical com Italy Mathys Ortopedia...

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