Luminus Flex Total Knee System (Fixed Type) The Innovative Technology for Knee Replacement

Luminus Flex Total Knee System (Fixed Type) The Innovative Technology for Knee Replacement

Intro The Luminus-Flex Total Knee system takes its name from the English word "Luminous" An adjective meaning radiating, shining or illuminating to describe the Gold Tin Ceramic coating. In combination with the latin root word "Flexus", meaning to bend, emphasises the full range of motion and smooth bending provided with the system. Advantages of L-F Total Knee System Deeper and wider proximal trochlear groove for the optimal patella tracking and more generous movement in both hyperflexion and rotation. Lengthened trochlear groove having shorter notch height supports the patella and quadriceps tendon in hyperflexion. Multi-axis design of femoral component with 9.5mm and 9mm of posterior and distal condyles thickness, allows minimum bone resection and enhancement in range of motion up to 150. Lengthened width of posterior condyles and unique posterior cam design assure a safe jump distance which reduces the risk of dislocation and contact stress on tibial insert in hyperflexion. Reduction in weight and risk for metal allergy by using titanium material, and enhancement in gravimetric wear rate on tibial insert and backside wear by applying Ceramic Titanium Nitride(TiN) coating. Deeper patella tendon relief minimizes the contract stress and patella impingement in hyperflexion. 3 of posterior Tibia Base Plate allowing hyperflexion for initial implant stability and reduction of the risk of anterior cortex impingement. 02

Advanced Bio-compatible Technology Weight Reduction in Titanium and TiN-Coating and Sanding Surface Treatments Titanium is used for Reduction of weight up to 50% compared to the weight of Total Knee Replacement system made by Co-Cr. The weight of L-F Femroal Component is similar to the bone resection weight that is removed from a patient during surgery. Moreover, unlike Co- Cr material there is no risk of metal allergy in titanium Nitride(TiN) coating and it provides better wear rate with UHMWPE Tibial Insert. In addition, the sanding surface treatment was applied to the inner surface of femoral component to provide better adhesion and integration with bone and cement material. Features Service Satisfaction Management Quality Best service for best customers Satisfactory services ranging from production to follow-up service Cares for you through reliable sales management We have always pursued the best quality Fixed Type 03

Luminus Flex Total Knee System (Fixed Type) Advanced Bio-compatible Technology L-F Femoral Component Lengthened Width of Posterior Condyles Enhancement in Posterior Cam Design Wider Proximal Trochlear Groove Deeper Trochlear Groove Longer Proximal Trochlear Groove Multi-axis for Bionic Profile Optimization in Tibia-Femoral Articulation 04

Deeper Trochlear Groove and Anterior Flange Geometry L-F Femoral Component has anterior flange shape for the optimal patella tracking and performance. This unique geometry supports more generous patella movement during both flexion and rotation. Reduction of Notch Height and Longer Trochlear Groove L-F Femoral Component (Size 3) 35mm (58.3%) L-F Femoral Component has a shorter notch height leading to lengthened trochlear groove to support the patella and quadriceps tendon in hyperflexion. Fixed Type 05

Luminus Flex Total Knee System (Fixed Type) Wider Proximal Trochlear Groove 0 ~15 L-F Femoral Component provides balance in patella performance through a widened trochelar floor to reduce constraining forces and shear stresses in extension. These features provide excellent patellar tracking regardless of the patient's Q-angle. Sagittal Geometry Features with Multi-axis for Bionic Profile 9.5 4 8.5 9.0 L-F Femoral Component has multi-axis design concept to accomodate bionic profile for articular stability and smoothness with flexion and enhancement in range of motion. The thickness of the posterior and distal condyles are 9.5mm and 9mm, respectively and the anterior flange angle is 4 degrees. These allow for less femoral bone resection. 06

Coronal Geometry Features L-F Femoral Component has fully congruent, spherical shaped, articular surface to reduce contact stress with tibial insert and to improve stability in physiological motion. The profile of lengthened width of posterior condyles provides increased contact area. Increased Range of Motion (150 ) L-F Femoral Component has increased posterior condyle thickness design to allow and oblige for patients to have up to 150 degrees of hyperflexion without the need of additional posterior condyles resection and patella impingement. Fixed Type 07

Luminus Flex Total Knee System (Fixed Type) Proportional of Femoral Component Sizes L-F Femoral Component posterior condyles size increases arithmetically with 2.5mm difference in size and this provides implant interchangeability within 2 sizes and better bone coverage. Enhancement in Posterior Cam Design L-F Femoral Component has intercondylar and unique posterior cam design of posterior stabilized total knee replacement to reduce the risk of dislocation and contact stress with tibial insert in Hyperflexion. 08

Advanced Bio-compatible Technology L-F Conforming Bearing Component Optimization in Surface Bearing Articulation Higher Flexion Patellar Tendon Relief Deeper Trochlear Groove Fixed Type 09

Luminus Flex Total Knee System (Fixed Type) Hyperflexion Patella Tendon Relief L-F Bearing Component have a deeper anterior relief to minimize the contact stress on patella tendon and the potential for patella impingement during Hyperflexion. Sagittal and Coronal Geometry Features Deep and Smooth curve Anterior tibial articular surface : for joint stability Posterior tibial articular surface : for joint function (deep flexion) L-F Bearing Component have high conformity at the frontal plane to improve contact area and has double radii at the sagittal plane for improved anterior stability and deep flexion. 10

Simulation of Contact Stresses on Tibial Insert using Finite Element Analysis(FEA) Comparison of Contact Stress on Tibial Insert during flexion L-F Bearing Component inserts produce less contact pressure and have greater contact area with Femoral Component as compared with other leading product. Verification using Wear Testing Experiment Product Bearing Type Volumetric Wear Rate(mm 3 /Mc) Cellumed Titanium/Conventional PE 40.2 Company B CoCr/Conventional PE 43.3 Table 4.4 : Comparison of Published Wear Rates per Million Cycles 50 40 30 mm 3 /Mc 20 10 0 Cellumed Company B Figure 4.3 : Comparison of Published Wear Rates According to mechanical simulation and wear testing experimental verification, L-F Bearing Component geometry provides significant reduction in gravimetric wear at 5.0 million cycles as compared with other leading product Fixed Type 11

Luminus Flex Total Knee System (Fixed Type) L-F Tibial Baseplate Advanced Bio-compatible Technology Tibial Baseplate Design with 3 degrees of Posterior Slope keel 12

Sagittal and Coronal Geometry Features 3 35/40mm L-F Tibial Baseplate has a stem with keel which has 3 degrees of posterior slope for enhanced initial implant stability and reduced anterior cortex impingement. It also provides the potential for deep flexion. Length of stem and thinckness of plate are 35mm and 6.5mm respectively. Prosthesis Strength Verification using Fatigue Testing Experiment Fatigue testings of tibial baseplates were performed with frequency of 10Hz at 10.0 million cycles in ambient air conditions. All products successfully completed 10 million cycles and showed no indications of fracture or failure. Moreover, there was no backside wear or any defeat due to Tin Coating. Fixed Type 13

Luminus Flex Total Knee System (Fixed Type) Dome Patella Geometry Features Advanced Bio-compatible Technology L-F Patella Component L-F Patella Component provides the optimal patella tracking and performance with anterior flange geometry of Femoral Component with deeper and wider trochlear groove. Simulation of Contact Stresses on Patella Component using Finite Element Analysis(FEA) L-F Patella Component produces up to 20% greater contact area with Femoral Component, leading to less contact pressure, during the flexion as compared with other leading product. 14

Implant Dimension Femoral Component Tibia Base Plate Bearing Component Patella Component (mm) (mm) (mm) (mm) Size AP ML H Size AP ML Size AP ML Size Radius Thickness 1 55.0 58.7 49.9 1 38.5 59.6 1 38.5 59.6 1 26 9 2 57.5 61.3 52.2 2 40.3 62.3 2 40.3 62.3 2 29 9 3 60.0 64.0 54.4 3 42.0 65.0 3 42.0 65.0 3 32 9 4 35 9 4 62.5 66.7 56.5 4 43.8 67.7 4 43.8 67.7 5 65.0 69.3 59.0 6 67.5 72.0 61.2 7 70.0 74.7 63.5 5 45.5 70.4 6 47.3 73.1 7 49.0 75.8 5 45.5 70.4 6 47.3 73.1 7 49.0 75.8 Fixed Type 15

Luminus Flex Total Knee System (Fixed Type) Advanced Bio-compatible Technology Optional Items Extension Rod Block (mm) (mm) Size Length Diameter Size AP ML 1 2 3 4 5 6 7 60 90 60 90 60 90 60 90 60 90 60 90 60 90 11.5 11.5 11.5 11.5 11.5 13.5 13.5 1 38.1 29.6 2 41.0 31.9 3 44.1 34.3 4 47.6 36.9 5 51.2 39.7 16

Ordering Information Description Cat.Code Size L-F Femoral Component 04-31-3201 1(RT) 04-31-3202 2(RT) 04-31-3203 3(RT) 04-31-3204 4(RT) 04-31-3205 5(RT) 04-31-3206 6(RT) 04-31-3207 7(RT) 04-31-4201 1(LT) 04-31-4202 2(LT) 04-31-4203 3(LT) 04-31-4204 4(LT) 04-31-4205 5(LT) 04-31-4206 6(LT) 04-31-4207 7(LT) Description Cat.Code Thickness Size L-F Conforming Bearing Component 04-33-0201 9mm 04-33-0202 11mm 04-33-0203 13mm 04-33-0204 15mm 04-33-0205 18mm 04-33-0206 9mm 04-33-0207 11mm 04-33-0208 13mm 04-33-0209 15mm 04-33-0210 18mm 04-33-0211 9mm 04-33-0212 11mm 04-33-0213 13mm 04-33-0214 15mm 04-33-0215 18mm 04-33-0216 9mm 04-33-0217 11mm 04-33-0218 13mm 04-33-0219 15mm 04-33-0220 18mm 04-33-0221 9mm 04-33-0222 11mm 04-33-0223 13mm 04-33-0224 15mm 04-33-0225 18mm 04-33-0226 9mm 04-33-0227 11mm 04-33-0228 13mm 04-33-0229 15mm 04-33-0230 18mm 04-33-0231 9mm 04-33-0232 11mm 04-33-0233 13mm 04-33-0234 15mm 04-33-0235 18mm 1 2 3 4 5 6 7 Fixed Type 17

Luminus Flex Total Knee System (Fixed Type) Ordering Information Description Cat.Code Size 04-32-1301 1 Description Cat.Code Length Size 01-16-1001 60mm 1 01-16-1002 90mm 04-32-1302 2 01-16-1001 60mm 01-16-1002 90mm 2 04-32-1303 3 01-16-1001 60mm 01-16-1002 90mm 3 L-F Tibia Baseplate 04-32-1304 4 L-F Modular Extension of Tibia 01-16-1001 60mm 01-16-1002 90mm 4 04-32-1305 5 01-16-1001 60mm 01-16-1002 90mm 5 04-32-1306 6 01-16-1003 60mm 01-16-1004 90mm 6 04-32-1307 7 01-16-1003 60mm 01-16-1004 90mm 7 Description Cat. Code. Size L-F Fixed All Poly Patella Component 04-34-0501 1 04-34-0502 2 04-34-0503 3 04-32-0504 4 Description Cat.Code Thickness Size L-F Wedge Block 04-35-0001 5mm 04-35-0006 8mm 04-35-0002 5mm 04-35-0007 8mm 04-35-0003 5mm 04-35-0008 8mm 04-35-0004 5mm 04-35-0009 8mm 04-35-0005 5mm 04-35-0010 8mm 1 2 3 4 5 18

Vision 2015 To become a leading musculoskeletal biotechnology company by 2015 through outsourcing and R&D Creative Management Developing new product and human resource development without fear of failure. Ethical Management Contributing to public health and welfare through biotechnology Communication Management Solidarity of employees, having efficient communication and close relationship with customers Fixed Type 19

www.cellumed.co.kr Cellumed Co., Ltd. aims to become a top musculoskeletal biotechnology company through research in the field of orthobiologics, medical device, bio-similar, and cell therapy. Cellumed is committed to the improvement of human health and the quality of life. We will continue to strive toward our goal of putting smiles on our patients faces as they recover their health and look forward better life. Visit www.cellumed.co.kr to see the innovative products of Cellumed. WORLD-LEADING ENTERPRISE IN THE BIOTECH INDUSTRY Cellumed Co., Ltd. #408, 409, 410 Acetechno tower 9, Gasan-dong, Geumcheon-gu, Seoul, Korea(153-782) TEL : +82-2-2104-0475 FAX : +82-2-2104-0473 E-mail : elodia@cellumed.co.kr www.cellumed.co.kr