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Total Knee Arthroplasty System
Overview

The SurgTech GENOLLTM Total Knee Arthroplasty System (TKA) is used for primary total knee replacement in skeletally mature individuals.

The system consists of GENOLL™PS FEMORAL COMPONENT, GENOLL™ TIBIAL BASEPLATE, GENOLL™PS TIBIAL INSERT & GENOLL™ 3-PEG PATELLA.

Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patello femorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: JWH
Dated: April 29, 2019
Received: May 3, 2019

New Materials, Wear Resistance 

Features
The SurgTech GENOLLTM Total Knee Arthroplasty System (TKA) is available in a wide range of sizes. Some notable design features include:
Features
  • Wide Range of Part Sizes
  • Matching Characteristics
  • Material & Design of Femoral Condyle
  • Material & Design of Tibial Insert
  • Material & Design of Tibial Baseplate
  • Material & Design of Patella
    Component 1: TIBIAL INSERT (AB-54/36 CD-61/40 EF-67/44 GH-72/46 IJ-78/50) 8/10/12/14/16MM - UHMWPE
    Component 2: TIBIAL BASEPLATE (A-54/36 B-58/38 C-61/40 D-64/42 E-67/44 F-69/45 G-72/46 H-75/48 I-78/50 J-82/53)
    Component 3: FEMORAL COMPONENT (53/49 56/52 59/54 62/57 65/59 68/61 71/63 74/65 77/68 80/72), Left/Right 
    Component 4: 3-PEG PATELLA (S-27/7 M-31/8 L-35/9) - UHMWPE
    1. The 1:2 Spec. matching relationship between meniscus & tibia bracket is adopted to reduce the meniscus spec. & facilitate operation;
    2. Various combinations can be realized according to the matching diagram to meet different clinical needs;
    3. High compatibility between the femoral condyle and the meniscus can meet the needs of special patients.
    1. Made of cast Co-Cr-Mo alloy;
    2. PS type and CR type meet the needs of different patients and doctors;
    3. Design the involute joint surface to reconstruct the movement track of the knee joint;
    4. After referring to design and adjustable osteotomy template, the installation position is more accurate and the operation is simpler;
    5. Customized special five-axis milling machine with high dimensional accuracy and good contour;
    6. The surface is highly polished, effectively reducing joint wear.
    1. Cast cobalt-chrome-molybdenum alloy;
    2. Fixed type and rotary type, meeting the needs of different patients and doctors;
    3. The lower part of tibia bracket is designed with thin wings, which can reduce bone loss of medullary cavity;
    4. The mating surface of the meniscus is highly polished to effectively reduce fretting wear;
    5. A 2:1 specification matching design was adopted between the meniscus to reduce the size of the meniscus and facilitate the operation.
    1. High crosslinking materials processed by irradiation crosslinking technology are adopted;
    2. Excellent wear resistance and biocompatibility, significantly improve the service life of joints;
    3. Various models are designed to meet different clinical needs;
    4. A 1:2 specification matching design is adopted between the tibia bracket to reduce the size of the meniscus and facilitate the operation.
    1. High crosslinking materials processed by irradiation crosslinking technology;
    2. Excellent wear resistance and biocompatibility, significantly improve the service life of joints;
    3. Cylinder and inverted groove design, more stable combination with bone cement.
Instruments

The design reduces space needed in the OR and facilitates efficient, effective in-hospital instrument processing.
Essential components of the SurgTech GENOLLTM Total Knee Arthroplasty (TKA) System Instrument Set includes:

Instruments
  • A Full Set of Tools No. 1 Layer 1
  • A Full Set of Tools No. 1 Layer 2
  • A Full Set of Tools No. 1 Layer 3
  • A Full Set of Tools No. 2 Layer 1
  • A Full Set of Tools No. 2 Layer 2
  • A Full Set of Tools No. 2 Layer 3
    1. Femoral Medullary Drill X 1; 2. T-shaped Intramedullary Rod X 1; 3. Sliding Hammer X 1; 4. Sickle Ruler L X 1; 5. Sickle Ruler S X 1; 6. Intercondylar Osteotomy Drill Sleeve (0-5) X 1; 7. Intercondylar Osteotomy Drill Sleeve (6-9) X 1; 8. Intercondylar Osteotomy Drill X 1; 9. Straight Bone Knife X 1; 10. 30° Bone Knife X 1; 11. Femoral Condyle Positioning Hole Drill X 1; 12. Femoral Condyle Impactor X 1; 13. Intramedullary Femoral Puller X 1; 14. Quick Connect Bit X 1; 15. Airfoil Bone Knife S X 1; 16. Airfoil Bone Knife M X 1; 17.  Airfoil Bone Knife L X 1; 18. Femoral Valgus Adjuster X 1.
    1. Ankle Holder X 1; 2. Tibial Plateau Osteotomy Template R X 1; 3. Tibial Plateau Osteotomy Template S X 1; 4. Tibial Plateau Depth Measuring Needle X 1; 5. Joint Gap Gauge X 1; 6. Universal Handle For Extramedullary Wire X 1; 7. Guide Pin L X 1; 8. Guide Pin S X 1; 9. Tibial Plateau Drill X 1; 10. Tibial Platform Installer X 1; 11. Meniscus Installer X 1; 12. Universal Handle X 1; Nail Holder X 1; 13. Nail Drawer X 1; 14. Temporary Fixing Nail L X 6; 15. Temporary Fixing Nail S X 6.
    1. Intercondylar Osteotomy Template (0/1, 2/3, 4/5, 6/7, 8/9) X 1; 2. Femoral Condyle Test Model (1L, 1R, 2L, 2R, 3L, 3R, 4L, 4R, 5L, 5R, 6L, 6R, 7L, 7R, 8L, 8R) X 1; 3. Femoral Condyle Test Model (0L, 0R, 9L, 9R) X 1 (Non-standard); 
    1. The Connector X 1; 2. Distal Femoral Osteotomy Template X 1; 3. Condylar Holder X 1; 4. Handle For Condylar Holder X 1; 5. Femoral Condyle Measuring Ruler X 1; 6. Femoral External Rotation Regulator L X 1; 7. Femoral External Rotation Regulator S X 1; 8. Osteotomy Template of Femoral Condyle (1#, 2#, 3#, 4#, 5#, 6#, 7#, 8#) X 1; 9. Osteotomy Template of Femoral Condyle (0#, 9#) X 1 (Non-standard); 10. Template Connector Handle for Femoral Condylar Osteotomy X 1; 11. Straight Shank Screwdriver X 1.
    1. Opening Pliers X 1; 2. Patellar Forceps X 1; 3. Patella Measuring Instrument (S, M, L) X 1; 4. Patellar Measuring Ruler X 1; 5. Patellar File X 1; 6. Patella Drill X 1; 7. Patellar Forceps X 1; 8. Patella Test Model (S, M, L) X 1; 9. Bone Pry X 1.
    1. Femoral Condyle Installer X 1; 2. Tibial Osteotomy Locator X 1; 3. Tibial Plateau Template (B, C, D, E, F, G, H, I) X 1; 4. Tibial Plateau Template (A, J) X 1 (Non-standard); 5. Tibial Bone Marrow Cavity Treatment Mold Sleeve X 1; 6. Handle for Meniscus Test X 1; 7. Meniscus Test Model (AB-8, AB-10, AB-12, AB-16, CD-8, CD-10, CD-12, CD-14, CD-16, EF-8, EF-10, EF-12, EF-14, EF-16, GH-8, GH-10, GH-12, GH-14, GH-16, IJ-8, IJ-10, IJ-12, IJ-14, IJ-16) X 1; 8. Meniscus Pillar X 1.
Indication


Indication:

1. Severe Knee Pain and Knee Dysfunction
2. Knee Deformities
3. Instability of Knee Joint
4. Loss of Motion of Knee Joint
5. Osteoarthritis
6. Late Lesions of Knee Joint Caused by Rheumatoid Arthritis and Ankylosing Spondylitis
7. Hemophilic Arthritis
8. Post Traumatic Osteoarthritis
9. Tumor Destroys Knee Joint and Rebuilds Knee Joint


Absolute Contraindications

1. Periarticular or Systemic Active Infection of The Knee
2. Failure to Reconstruct Knee Extension Function
3. Extensive Soft Tissue Damage Around Knee Joint Cannot Be Corrected Effectively
4. limbal Vascular Pathological Changes
5. Poor General Condition and Intolerance of Surgery, such as Severe Cardiopulmonary Disease, Diabetes Mellitus, etc.
6. Severe Osteoporosis


Relative Contraindication

1. Young, Obese, High Knee Load
2. Dysfunction of Knee Extension and Surrounding Soft Tissue Defect Can Be Corrected
3. The Knee Has a History of Infection
4. The Knee Joints are Stiff and Painless
5. Hemophilia, Complications

 

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