Total Knee Replacement System - Triathlon All Poly Tibial Component - India CDSCO Medical Device Registration
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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
Antibiotic Simplex
License Holder
M/s Stryker India Private Ltd.,Device Class
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
Bone Cement(Simplex P Bone Cement )
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Antibiotic Bone Cement(Antibiotic Bone Cement Simplex P )
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee Replacement System-Patella
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Modular replacement System
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Modular replacement System
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Hip replacement system
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee Replacement System-Patellar components
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee replacement System
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Rotating Hinge Knee System - Kinematic
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Bone Cement
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Inzone Detachment System
Brand: Inzone Detachment System
AXS Vecta Intermediate Catheter
Brand: AXS INFINITY LS PLUS Long Sheath
AXS INFINITY LS PLUS Long Sheath
Brand: AXS INFINITY LS PLUS Long Sheath
SPS Instruments
Brand: SPS
PRO System Instruments
Brand: SPS
Trauma Plating System
Brand: Bone Screws
Bone Screws
Brand: Bone Screws
Trauma Plating System
Brand: PRO System
Defibrillator
Brand: LIFEPAK 20e Monitor/Defibrillator and accessories
Defibrillator
Brand: LIFEPAK 20e Monitor/Defibrillator and accessories