CDSCO UID IMP/MD/2019/000088_34c2e41e8e18584bcde6363d92a64ef3_1a5e7bf3a007b1c24c60790332c7cdfb
Total Knee Replacement System
Stryker India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: Trident II Acetabular Component System
Registration details
- UID
- IMP/MD/2019/000088_34c2e41e8e18584bcde6363d92a64ef3_1a5e7bf3a007b1c24c60790332c7cdfb
- Device class
- Class C
- Brand name
- Trident II Acetabular Component System
- License holder
- Stryker India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- General Total Knee Arthroplasty (Trident II Acetabular Component System) Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (Trident II Acetabular Component System), rheumatoid arthritis or post-traumatic arthritis. • Posttraumatic 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 Tritanium Tibial Baseplate and Tritanium Metal- Backed Patella components are indicated for both uncemented and cemented use. The Triathlon Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only. The Triathlon All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (Trident II Acetabular Component System) and Total Stabilizer (Trident II Acetabular Component System) 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 (Trident II Acetabular Component System) Components: • Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: • Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. • Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments • Severe degeneration or trauma requiring extensive resection and replacement • Femoral and tibial bone voids • Metaphyseal reconstruction The Triathlon Tritanium® Cone Augment components are intended for cemented or cementless use
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About this record
Total Knee Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_34c2e41e8e18584bcde6363d92a64ef3_1a5e7bf3a007b1c24c60790332c7cdfb. This device is marketed under the brand name Trident II Acetabular Component System. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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