CDSCO UID IMP/MD/2020/000070_89ff1ca23adfc3e47c68d6701c18aef1_d697fe2c00309e8926a23d4bc67ba069
Total Knee Replacement System - Triathlon All Poly Tibial Component
M/s Stryker India Private Ltd.,·Device Class Class C·India CDSCO·Brand: Antibiotic Simplex
Registration details
- UID
- IMP/MD/2020/000070_89ff1ca23adfc3e47c68d6701c18aef1_d697fe2c00309e8926a23d4bc67ba069
- Device class
- Class C
- Brand name
- Antibiotic Simplex
- License holder
- M/s Stryker India Private Ltd.,
- Approving authority
- CDSCO
- Product information
- General Total Knee Arthroplasty (Antibiotic Simplex) Indications: • Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (Antibiotic Simplex), rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure. • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture –management techniques. The Triathlon All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (Antibiotic Simplex) and Total Stabilizer (Antibiotic Simplex) Components: • Ligamentous instability requiring implant bearing surface geometries with increased constraint. • Absent or non-functioning posterior cruciate ligament. • Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (Antibiotic Simplex) Components: • Severe instability of the knee secondary to compromised collateral ligament integrity or function
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About this record
Total Knee Replacement System - Triathlon All Poly Tibial Component is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_89ff1ca23adfc3e47c68d6701c18aef1_d697fe2c00309e8926a23d4bc67ba069. This device is marketed under the brand name Antibiotic Simplex. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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