Implants and Instruments

Transcription

1 GEMINI SL Total Knee Replacement cementable / cementless with TiCaP Mobile Bearing Fixed Bearing Fixed Bearing PS MIT-K Navigation Standard Instrument Set Implants and Instruments

2 Presented by: WALDEMAR LINK GmbH & Co. KG Barkhausenweg Hamburg, Germany P.O. Box Hamburg, Germany Tel.: Fax: info@linkhh.de Internet:

3 Contents System Description GEMINI SL Total Knee Replacement cementable / cementless with TiCaP System Description 02 GEMINI SL Total Knee Replacement 0 Indications/Contraindications 07 MIT-K Minimally Invasive Technique-Knee Implants Femoral Components 0 Femoral components, MOBILE / FIXED BEARING, cementable/cementless Tibial Components 09 Tibial components, MOBILE BEARING, cementable/cementless Articulating surfaces, MOBILE BEARING Tibial components, FIXED / FIXED BEARING PS, cementable/cementless 13 Articulating surfaces, FIXED BEARING Fixed Bearing PS (Posterior Stabilized) 15 Femorale components, FIXED BEARING PS, cementable/cementless Articulating surfaces, FIXED BEARING PS Indications Contraindications Instrument Set Implants Taper caps for tibial component, patella components 19 Prothesis stems for tibial stem extensions, cementable/cementless Instrument Set 20 MIT-K Minimally Invasive Technique-Knee, basic instrument set 27 MIT-K instruments for FIXED BEARING PS 2 Additional instruments MIT-K 29 Standard instrument set GEMINI SL (optional) Accessories 30 X-rays 31 Further informationen about GEMINI SL 32 Index Important information for use of our implants 01 Accessories Index Important Information

4 System Description GEMINI SL Total Knee Replacement The LINK GEMINI Total Knee Replacement, including implants and system-specific instruments, is part of the LINK SL Knee Family concept. SL stands for System-integrated SoLution One implant system for standard implantation and revision Essential criteria for obtaining good results in knee arthroplasty are long-term fixation, anatomically correct implant components and a reproducible implantation technique. The LINK GEMINI knee implant for cementable or cementless primary replacement of damaged knees combines tried-and-tested and innovative principles of design. The design of the femoral and tibial components and a wide choice of sizes ensure primary stability. The tibial components are available with either a MOBILE BEARING or a FIXED BEARING. The optimal surface texture and our TiCaP double coating Titan (Ti)/Calcium Phosphate (CaP) provide secondary fixation for cementless implantation. 02

5 System Description GEMINI SL Total Knee Replacement System Description Flexibility The resections made for GEMINI total knee replacement allow the surgeon to switch intraoperatively to the SL rotating hinge or hinged knee implants and to use the MEGASYSTEM-C variants if indicated, with the aid of just a few additional instruments, because each knee system within the SL Knee Family is compatible with the very same bone resection (see page ). Indications Contraindications Modularity The GEMINI SL product range guarantees optimal compatibility and is an excellent treatment option for the patient. A uniform femoral component for FIXED BEARING and MOBILE BEARING and a different femoral component for FIXED BEARING PS (Posterior Stabilized) are available. A compatible PE articulating surface must be selected in each case. This gives the surgeon great intraoperative flexibility. The GEMINI SL system caters for a range of femoral and tibial dimensions, offering uncompromising treatment for the patient. Instrument Set Implants Femoral component A major contributing factor to the long-lasting function of the GEMINI SL system is the frictional connection between the fixation surfaces and the resected femoral condyles, and also the external form of the femoral component, which is modeled on the anatomy of the knee and implant function. The high patella shield prevents the patella from clicking in cases of patella alta. The carefully deep shaped patellar groove provides for anatomical tracking of the bony patella or patella resurfacing component in all positions. Accessories The femoral component comes in two variants for cementable or cementless fixation. 03 Index Important Information

6 System Description GEMINI SL Total Knee Replacement The posterior stabilized (PS) design with its mechanical stop makes for a secure coupling mechanism. This prevents ventral femoral subluxation in flexion after resection or in the absence of the posterior cruciate ligament. The special design of the box geometry allows for bonesparing resection. Tibial component The GEMINI tibial components are modeled on the anatomy of the tibial head, and and variants are available. The central taper and the bars radiating out toward dorsal have been shown in various tests* to protect against shear forces, rotation and, above all, the alternating varus/valgus loads that cause loosening. The tapered pegs at the ends of the bars transmit forces laterally into the load-bearing cortical bone. The concave surface of mobile bearing tibial plateau (A) provides congruency of the articulating surfaces in extension while allowing the femoral condyles to glide in increasing flexion. Distribution of the load over a area limits polyethylene wear. The rotating articulating surface separates function from movement in the articulating areas, enabling the soft tissue structures to take over motion control, which makes for natural kinematics. In addition, the implant fixation is spared. The deep trough in the tibial plateau stabilizes the knee, even in cases of posterior cruciate ligament deficiency.** A In cases of good joint stability, where the ligaments and capsule are intact, a tibial tray with a replaceable fixed bearing PE articulating surface is available (B). B * Fabriciani C. et al.: Total Knee Arthroplasty, Tibial Components: Design and Surfaces, Cementless Arthroplasty, M. D Arienzo, R. Civinni, B. Pavolini, Aulo Gaggi Editore, Bologna Crownshiled R.D., Murase K., Pedersen D.R.: An analysis of tibial component design in total knee arthroplasty. Presented at the 2th Annual ORS, New Orleans, Jan 19-21, 192 Walker P.S. et al.: Fixation of Tibial Components of Knee Prostheses, JBJS 3-A, No.2, 191, pp C Walker P.S., Hu-Ping Hsu, Ziermann R.A.: A comparative study of uncemented tibial components, J. of Arthrop., Vol. 5, No. 3, 1990, pp. 24 ** Christine S. Heim,BSc, Paul D. Postak, BSc, Nicholas A. Plaxton, MS, A. Seth Greenwald, DPhil (Oxon): Classification of Mobile-Bearing Knee Designs: Mobility and Contraint, The JBJS (American) 3:S32-37 (2001) 04

7 System Description GEMINI SL Total Knee Replacement System Description In the absence of the posterior cruciate ligament, function is assured by the post coupling mechanism. This induces mechanical rollback while preventing posterior subluxation of the tibia. Ventrally, the PS (posterior stabilized) polyethylene articulating surface (C) has a deep cutout to give the extension apparatus enough space in flexion. C Indications Contraindications Taper cap/prosthesis stems The taper below the tibial metal tray can be fitted with a taper cap (D). In cases of instability or insufficient bone quality, in particular, this taper allows a cementable (E) or cementless (F) stem to be connected. Anchorage The bone contact surfaces on the tibial and femoral components have an SMS (Squarical Monobloc Structure) honeycomb macrostructure and an additional microstructure for cementable fixation. For cementless fixation, implants with TiCaP double coating Ti tan (Ti)/Calcium Phosphate (CaP) are available. D E F Instrument Set Implants TiCaP double coating: Titan (Ti)/Calcium Phosphate (CaP) The TiCaP coating is applied to implants by firstly spraying a highly porous layer of titanium approximately 200 µm* thick onto the surface of the implant using vacuum plasma technology. On top of this porous surface, an approx. 20 µm** thick layer of extremely mechanically stable calcium phosphate is deposited in an electrochemical process, which promotes ingrowth into the open-cell titanium layer. Animal experiments have demonstrated ingrowth on.9% of the implant surface.** 2.000x 400x * The thickness of the titanium layers varies in different types of implant. ** Cunningham B W et al.: General Principles of Total Disc Replacement Arthroplasty, Spine, Vol 2, No 20 Suppl, Accessories Index Important Information

8 System Description GEMINI SL Total Knee Replacement Resections compatible with Endo-Model SL rotating and hinge knee The tibial and femoral resections for sizes 2, 3 and 4 of the LINK GEMINI Total Knee Replacement are identical to those required for the corresponding sizes of Endo-Model SL rotating hinge knee: Size 2 GEMINI SL corresponds to size ROKNEP SL Size 3 GEMINI SL corresponds to size ROKNEP SL Size 4 GEMINI SL corresponds to size ROKNEP SL After resection of the femur (for which the additional instrument set -0001/02, Endo-Model SL rotating knee is necessary), it is possible to switch intraoperatively or revise with the SL constrained total knee system. GEMINI SL ROKNEP SL Indications/Contraindications Note: Specified indications/contraindications see catalogs: 737_GEMINI SL Total Knee Replacement, Surgical Technique Standard 732_MIT-K for GEMINI SL Total Knee Replacement, Surgical Technique Minimally Invasive Technique-Knee 0

9 System Description MIT-K Minimally Invasive Technique - Knee The success of total knee arthroplasty depends upon: Correct alignment of the leg axis Good soft-tissue balancing Stable primary fixation of the implant The MIT-K Minimally Invasive Technique Knee presents a tissue-sparing surgical technique for implanting the GEMINI SL prosthesis via a incision. This leads to less blood loss, both during and after surgery, while preserving muscles, tendons and ligaments. The risk of infection and embolism is reduced; wound healing is improved and the patient recovers faster. Navigation Accurate and preserving Precise, tissue-sparing implantation The newly developed, state-of-the-art instrument set and the optional computerassisted navigation system BLU-IGS (from company Orthokey) facilitate precise alignment of the axes and positioning of the resection guides. The instruments are compact, so they do not impinge on surrounding soft tissue. Indications Instrument Set Implants Systemb Description Contraindications These features ensure that the patient gets the maximum life from the artificial joint, optimal function, and the minimally invasive technique means short convalescence. Accessories 07 Index Important Information

10 Implants GEMINI SL Femoral Components MOBILE / FIXED to use with MOBILE and FIXED BEARING cementable CoCrMo alloy A B 3-2/01 3-2/02 3-2/25 3-2/2 3-2/03 3-2/04 3-2/05 x- plus A B 3-3/01 3-3/02 3-3/25 3-3/2 3-3/03 3-3/04 3-3/05 x- plus A B cementless with TiCaP ** CoCrMo alloy A B 3-204/ / / / / / /05 x- plus A B 3-205/ / / / / / /05 x- plus A B ** TiCaP double coating: Titan (Ti)/Calcium Phosphate (CaP) 0

11 Implants GEMINI SL Tibial Components MOBILE to use with MOBILE BEARING System Description cementable CoCrMo alloy A B Indications Contraindications 3-3/01 3-3/02 3-3/03 3-3/04 3-3/05 x / / / / /05 x- Implants cementless Instrument Set with TiCaP ** CoCrMo alloy A B 3-3/01 3-3/02 3-3/03 3-3/04 3-3/ / / / / /05 x- x- Accessories ** TiCaP double coating: Titan(Ti)/Calcium Phosphate (CaP) 09 Index Important Information

12 Implants GEMINI SL PE Articulating Surfaces MOBILE to use with MOBILE BEARING UHMW polyethylene H h A B 3-431/ 3-432/ 3-437/ x- plus A B 3-433/ 3-434/ 3-435/ / 3-4/ 3-4/ 3-443/ 3-444/ 3-445/ x- plus A B 3-431/ 3-432/ x / 3-433/ 3-434/ 3-435/ plus A B 3-441/ 3-4/ 3-4/ 3-443/ 3-444/ 3-445/ x- plus A B 3-431/ 3-432/ x / 3-433/ 3-434/ 3-435/ plus A B further implant sizes see next page...

13 Implants GEMINI SL PE Articulating Surfaces MOBILE to use with MOBILE BEARING System Description UHMW polyethylene H h A B Indications Contraindications 3-441/ 3-4/ 3-4/ x- plus A B 3-443/ 3-444/ 3-445/ 3-431/ 3-432/ 3-437/ x- plus A B Implants 3-433/ 3-434/ 3-435/ / 3-4/ 3-4/ 3-443/ 3-444/ 3-445/ x- plus A B Instrument Set Tibial component (mobile bearing) Polyethylene articulating surfaces (mobile bearing) Femoral component Accessories 11 Index Important Information

14 Implants GEMINI SL Tibial Components FIXED / FIXED PS to use with FIXED and FIXED BEARING PS* cementable incl. safety bolt for PE articulating surface CoCrMo alloy A B Taper / 3-372/ / / / /05 x / / / / /05 x- * to use with femoral components: MOBILE BEARING, page 0 and MOBILE BEARING PS (Posterior Stabilized), page 15. cementless incl. safety bolt for PE articulating surface with TiCaP ** CoCrMo alloy A B Taper / 3-37/ / / / /05 x / / / / /05 x- * to use with femoral components: MOBILE BEARING, page 0 and MOBILE BEARING PS (Posterior Stabilized), page 15. ** TiCaP double coating: Titan (Ti)/Calcium Phosphate (CaP)

15 Implants GEMINI SL PE Articulating Surfaces FIXED to use with FIXED BEARING System Description Indications Contraindications UHMW polyethylene H h A B 3-231/ 3-232/ 3-237/ 3-233/ 3-234/ 3-235/ x- plus A B Implants 3-241/ 3-2/ x- 3-2/ 3-243/ 3-244/ 3-245/ 3-231/ 3-232/ plus x- A B Instrument Set 3-237/ 3-233/ 3-234/ 3-235/ plus A B 3-241/ 3-2/ 3-2/ 3-243/ 3-244/ 3-245/ x- plus A B Accessories 3-231/ 3-232/ 3-237/ 3-233/ 3-234/ 3-235/ x- plus further implant sizes see next page... A B 13 Index Important Information

16 Implants GEMINI SL PE Articulating Surfaces FIXED to use with FIXED BEARING UHMW polyethylene H h A B 3-241/ 3-2/ 3-2/ 3-243/ 3-244/ 3-245/ x- plus A B 3-231/ 3-232/ x / 3-233/ 3-234/ 3-235/ plus A B 3-241/ 3-2/ 3-2/ x- plus A B 3-243/ 3-244/ 3-245/ 3-231/ 3-232/ 3-237/ x- plus A B 3-233/ 3-234/ 3-235/ 3-241/ 3-2/ 3-2/ 3-243/ 3-244/ 3-245/ x- plus A B

17 Implants GEMINI SL Femoral Components FIXED PS to use with FIXED BEARING PS* System Description cementable CoCrMo alloy A B Indications Contraindications 3-1/01 3-1/02 3-1/25 3-1/2 3-1/03 3-1/04 3-1/ / / / / / / /05 x- plus x- plus A B A B Implants * to use with tibial components (FIXED BEARING), page cementless Instrument Set with TiCaP ** CoCrMo alloy A B 3-2/01 3-2/02 3-2/25 3-2/2 3-2/03 3-2/04 3-2/05 x- plus A B Accessories 3-213/ / / / / / /05 x- plus * to use with tibial components (FIXED BEARING), page ** TiCaP double coating: Titan (Ti)/Calcium Phosphate (CaP) A B 15 Index Important Information

18 Implants GEMINI SL PE Articulating Surfaces FIXED PS to use with FIXED BEARING PS* UHMW polyethylene H h A B 3-251/ 3-252/ x- 3-2/ 3-2/ 3-254/ 3-255/ plus A B 3-21/ 3-2/ x- 3-2/ 3-23/ 3-24/ 3-25/ plus A B 3-251/ 3-252/ x- 3-2/ 3-2/ 3-254/ 3-255/ plus A B 3-21/ 3-2/ x- 3-2/ 3-23/ 3-24/ 3-25/ plus A B * to use with tibial components (FIXED BEARING), page further implant sizes see next page...

19 Implants GEMINI SL PE Articulating Surfaces FIXED PS to use with FIXED BEARING PS* System Description 3-251/ 3-252/ 3-2/ 3-2/ 3-254/ 3-255/ UHMW polyethylene x- plus H h A B A B Indications Contraindications 3-21/ 3-2/ 3-2/ 3-23/ 3-24/ 3-25/ x- plus A B Implants 3-251/ 3-252/ 3-2/ 3-2/ 3-254/ 3-255/ 3-21/ 3-2/ 3-2/ 3-23/ 3-24/ 3-25/ x- plus x- plus A B A B Instrument Set 3-251/ 3-252/ 3-2/ 3-2/ 3-254/ 3-255/ x- plus A B Accessories 3-21/ 3-2/ 3-2/ 3-23/ 3-24/ 3-25/ x- plus * to use with tibial components (FIXED BEARING), page A B 17 Index Important Information

20 Implants GEMINI SL Total Knee Replacement Ø L Taper caps for tibial components CoCrMo alloy 3-3 Ø, length (L) 2 cementable cementless with TiCaP * CoCrMo alloy The taper of the tibial component for coupling with modular stems can be covered with the taper cap, thus providing a short prosthesis stem (overall length = 49 ). The cap is fixed to the taper by means of a hex screw using hex screwdriver 4-11/0 (hex. 2.0 ). 3-3/01 Ø, length (L) 2 * TiCaP double coating: Titan (Ti)/Calcium Phosphate (CaP) Patella resurfacing components, cementable Ø H Item No. UHMW Polyethylene Ø Height 3-400/25 Size /2 Size /31 Size /34 Size 4 34 Instrument set for patella components available on request.

21 Implants GEMINI SL Total Knee Replacement System Description Ø D Prothesis stems for tibial stem extensions cementable Tilastan Ø B L Indications Contraindications Ø A Ø B Ø D L LT 3-190/ / 3-190/ Ø A Prothesis stems for tibial stem extensions cementless 3-191/ / 3-191/ Ø A Tilastan Ø B Ø D L LT Accessories Implants Ø D Ø B L Instrument Set LT 19 Index Important Information

22 Instrument Set MIT-K Basic Instrument Set for GEMINI SL Total Knee Replacement II I III IV V VI / / /03 MIT-K Basic Instrument Set Complete set in 4 standard containers N11 and 2 standard containers N21, instruments on trays with products and storage racks. Standard container N11, empty, stainless steel, 575 x 275 x 0 Standard container N21, empty, stainless steel, 575 x 275 x 130 Trays, empty, stainless steel: /01 Tray I, 550 x 25 x / / / / /0 Tray II, 550 x 25 x 50 Tray III, 550 x 25 x 50 Tray IV, 550 x 25 x 50 Tray V, 550 x 25 x 50 Tray VI, 550 x 25 x 50 20

23 Instrument Set Tray I MIT-K Basic Instrument Set System Description Indications Contraindications Implants / / / / / / / / / Femoral controll blocks for femoral components size 1, for femoral components size 2, for femoral components size 2A, for femoral components size 3, for femoral components size 4, for femoral components size 5, yellow green green blue black brown Impactor for tibial components, incl. PE plateau, rotational version for size 1-2 for size 2A, 3, 4 for size 5 Instrument Set / / / / / /2 Femoral cutting blocks size 1 size 2 size 2A size 3 size 4 size /32 Chisel for patella glide, / Femoral cutting block inserter /57 Handle, 150 Accessories / / / / / /3 Dove tail adapter for femoral cutting blocks for size 1 neutral for size for size for size 2-5 neutral for size for size /55 Alignment instrument for external rotation, complete (3 parts) /4 Stylus for control block femur / Cutting template 21 Index Important Information

24 Instrument Set Tray II MIT-K Basic Instrument Set /31 Femoral sizer /39 Alignment instrument for valgus angulation, complete (2 parts) / Foot clam, adjustable / / / /43 Distal cutting blocks for size 1 for sizes 2+2A for size 3 for sizes / Orientation rod tibia, complete /50 Tibial saw guide, /5 Alignment rods for epicondyles, 0 (2 ea. included in container) /51 Tibial saw guide, /52 Stylus for tibial saw guide, adjustable (2 parts) /95 Fixation pins, Ø 3, 95 (2 ea. included in container) 22

25 Instrument Set MIT-K Basic Instrument Set Tray III System Description 21 Implants Indications Contraindications /30 Alignment rod, Ø, Spacers for flexion-extension gap for femoral components: colour: height: / / / / / / size 1 yellow size 1 yellow size 1 yellow sizes 2+2A green sizes 2+2A green sizes 2+2A green Instrument Set 317-0/ 317-0/ 317-0/ size 3 blue size 3 blue size 3 blue / / / 317-0/ 317-0/ 317-0/ size 4 black size 4 black size 4 black size 5 brown size 5 brown size 5 brown Accessories Optional Spacers for FIXED and FIXED BEARING PS high, for flexion-extension gap (not included in Tray III) / / 317-0/ / 317-0/ for femoral components: colour: height: size 1 yellow sizes 2+2A green size 3 blue size 4 black size 5 brown 23 Index Important Information

26 Instrument Set MIT-K Basic Instrument Set Tray IV Hex screwdriver for trial plateaus, SW 2.5, Alignment rod (extramedullary), Attachable handle and impactor for tibial baseplate trials, E* Trephine, with fitting Jacobs chuck E*, 200 (* additional fittings see page 2) Cancellous bone compressor, Sleeve for cancellous bone compressor and tibial base trials, Insertion forceps for trial plateaus and shims, Trial plateaus for femoral components: colour: / / / / /05 size 1 sizes 2+2A size 3 size 4 size 5 yellow green blue black brown 31 Tibial base trials for tibial metal casings: / / / / /05 size 1 size 2 size 3 size 4 size /01 size /02 size /03 size /04 size /05 size Drill guide for trephine 33 Shims / / / / for height for height for height for height 24

27 Instrument Set MIT-K Basic Instrument Set Tray V Indications Contraindications System Description Implants /01 Attachable handle and impactor for femoral components, Driver for femoral components, Rasp for patella glide, Bone awl with trocar point, Threaded pins for femoral trials (2 ea. included in container) Drill guides for femoral trials (2 ea. included in container) 40 Femoral trials standard* Instrument Set 317-7/ / / / / / /05 size 1 size 2 size 2A size 2B size 3 size 4 size / / / /2 317-/ / /05 size 1 size 2 size 2A size 2B size 3 size 4 size 5 Accessories * Trial components for use with MIT-K or standard surgical technique 25 Index Important Information

28 Instrument Set MIT-K Basic Instrument Set Tray VI /0E* Twist drill to open femoral and tibial cavity, Ø, 0, with fitting Jacobs chuck E* /0E* Twist drill for pilot holes of femoral trials, Ø 5,5, 0, with fitting Jacobs chuck E* Extraction instrument (4 parts) for femoral trials /0 Hex screwdriver, hex 2, /95 Fixation pins, Ø 3, 95 (5 ea. included in container) Driver and extraction forceps for fixation pins, Guide rod (intramedullary), Ø, Tibial impactor to drive tibial components home, Tibial sizers / / / / /15 size 1 size 2 size 3 size 4 size Hex screwdriver, hex 3, Universal wrench, hex, for guide nuts, 0 * Fittings optional: B C D E H Hudson Harris A-O Jacobs Zier How to order: /0B = with Hudson fitting 2

29 Instruments MIT-K Instruments for PS (POSTERIOR STABILIZED) System Description Box guide Size 317-/ / / /2 317-/ / /05 size1 size 2 size 2A size 2B size 3 size 4 size 5 Indications Contraindications Notch trephine for box guide Size /01B /02B /25B /03B /04B /05B size 1 size 2 size 2A/2B size 3 size 4 size 5 Implants Trial plateaus Size / / / / / /05 size 1 size 2 size 2A/2B size 3 size 4 size 5 Instrument Set Femoral trial box Size 317-/ / / /2 317-/ / /05 size 1 size 2 size 2A size 2B size 3 size 4 size 5 Accessories 317- Fixation screw, for femoral trial prosthesis with trial box GEMINI Screwdriver for safety bolt for PE articulating surface (FIXED + FIXED BEARING PS) 27 Index Important Information

30 Instruments MIT-K Additional Instruments (not included in MIT-K Basic Instrument Set) 317-5/01 Gauge for ligament tension Screwdriver for safety bolt for PE articulating surface (FIXED + FIXED BEARING PS) Saw blade, without offset teeth, 1.24 thick wide Fitting / 317-/ Synthes / /11 Aesculap combi / 317-/ 3M / /13 Zier/Hall combi / 317-/ Stryker system 4 2

31 Instrument Set Standard Instrument Set for GEMINI SL Total Knee Replacement optional for the MIT-K Basic Instrument Set System Description I II Indications Contraindications III IV Implants V Instrument Set GEMINI SL Standard Instrument Set, complete / /03 Set in 5 standard containers, on 5 trays, with product and storage racks Standard container N11, empty, 4 ea. stainless steel, 575 x 275 x 0 Accessories /03 Standard container N21, empty, stainless steel, 575 x 275 x ea. Trays, empty, stainless steel: /11 Tray I, 550 x 25 x / / / /15 Tray II, 550 x 25 x 50 Tray III, 550 x 25 x 50 Tray IV, 550 x 25 x 50 Tray V, 550 x 25 x Index Important Information

32 Accessories X-ray templates for GEMINI SL, Set contains femoral and tibial implants (MOBILE and FIXED BEARING), 1% actual size, 1 set of sheets X-ray templates for GEMINI SL - PS version, Set contains femoral and tibial implants (POSTERIOR STABILIZED), 1% actual size, 1 set of 7 sheets 30

33 Accessories Additional information for GEMINI SL Total Knee Replacement Surgical technique - standard (German/English) System Description Surgical technique - MIT-K Minimally Invasive Technique-Knee (German/English) available on request. Indications Contraindications Accessories Instrument Set Implants Additional information for patella components Surgical technique GEMINI SL patella components available on request. 31 Index Important Information

34 Index /03, / , / / , / / /11 to / /... 20, /01 to 317-/ /25, 317-/ /01 to / /25, / E* /0E* / /0E* / to / / to 317-/ /01 to 317-7/ /25, 317-7/ /01 to 317-/ /25, 317-/ /01 to 317-/ /25, 317-/ /11 to / /01 to / /01 to / /01 to / /01 to / / to / / / to / /20 to / / / / /33 to / / /40 to / / / / / / / / / / / / /1 to / /01 to / / to 317-0/ / to / / to / / to 317-0/ / to / / to 317-0/ /01 to 3-2/ /25, 3-2/ /01 bis 3-3/ /25, 3-3/ /01 to 3-1/ /25, 3-1/ /01 to 3-113/ /25, 3-113/ /07, /, / /07, /, / /01 to 3-204/ /25, 3-204/ /01 to 3-205/ /25, 3-205/ /01 to 3-2/ /25, 3-2/ /01 to 3-213/ /25, 3-213/ / to 3-237/ / to 3-237/ / to 3-237/ / to 3-237/ / to 3-237/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-222/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ / to 3-2/ /01 to 3-3/ /01 to 3-313/ , 3-3/ /01 to 3-3/ /01 to 3-317/ /01 to 3-372/ /01 to 3-373/ /01 to 3-37/ /01 to 3-377/ /25 to 3-400/ / to 3-437/ / to 3-437/ / to 3-437/ / to 3-437/ / to 3-4/ / to 3-4/ / to 3-4/ / to 3-4/ ,2

35 Important Information Please note the following regarding the use of our implants: 1. Choosing the implant is extremely important. The size and shape of the human bone determine the size and shape of the implant and also limit the load capacity. Implants are not designed to withstand unlimited physical stress. Demands should not exceed normal functional loads. 2. Correct handling of the implant is exceedingly important. Under no circumstances should the shape of a finished implant be altered, as this shortens its life span. Our implants must not be combined with implants from other manufacturers. The instruments indicated in the Surgical Technique must be used to ensure safe implantation of the components. 3. Implants must not be reused. Implants are supplied sterile and are intended for single use only. Used implants must not be reused. 4. After-treatment is also very important. The patient must be informed of the limitations of the implant. The load capacity of an implant cannot compare with that of healthy bone! 5. Unless otherwise indicated, implants are supplied in sterile packaging. Note the following conditions for storage of packaged implants: Avoid extreme or sudden changes in temperature. Sterile implants in their original, intact protective packaging may be stored in permanent buildings up until the Use by date indicated on the packaging. They must not be exposed to frost, dampness or direct sunlight, or mechanical damage. Implants may be stored in their original packaging for up to 5 years after the date of manufacture. The Use by date is indicated on the product label. Do not use an implant if the packaging is damaged.. Traceability is important. Please use the documentation stickers provided to ensure traceability. 7. Further information on the material composition is available on request from the manufacturer. Follow the instructions for use! WALDEMAR LINK GmbH & Co. KG, Hamburg All content in this catalog, including text, pictures and data, is protected by copy. Every instance of use not permitted by the German Copy Act is subject to our prior consent. In particular, this applies to the reproduction, editing, translation, saving, processing or passing on of content stored in databases or other electronic media and systems. The information in this catalogue is solely intended to describe the products and does not constitute a guarantee. The Surgical Technique described has been written to the best of our knowledge and belief, but it does not relieve the surgeon of his/her responsibility to duly consider the particularities of each individual case. Unless otherwise indicated, all instruments are made of surgical stainless steel.

36 LINK 737en./Impl.Instr./03./002 WALDEMAR LINK GmbH & Co. KG Barkhausenweg Hamburg, Germany P.O. Box Hamburg, Germany Tel.: Fax: info@linkhh.de Internet: