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
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
Contact
Tel: (440) 899-2922 E-mail: chengbao@surgtech-med.com Address: 24600 Center Ridge Road, Suite 195 Westlake OH 44145