Knee System - Stem
- UID
- IMP/MD/2019/000423_e4aec191fc1ac624ac5a7d1185285617_aa85257f79554520f1d713d8408f70a2
- Device class
- Class D
- Brand name
- PFC Sigma
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- Total knee arthroplasty is a total joint replacement surgery designed to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely disabled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives. Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient
Knee System - Stem is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000423_e4aec191fc1ac624ac5a7d1185285617_aa85257f79554520f1d713d8408f70a2. This device is marketed under the brand name PFC Sigma. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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