Total Hip System - India CDSCO Medical Device Registration

Total Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000146_08226695ea318b8832570f14edad039e_f9efa90e2570a6701edf101b6565e3c0. This device is marketed under the brand name Profemur, Profemur Gladiator Classic, Profemur TL Classic, Procotyl L, Dynasty, Cancellous Bone Screw, Rim-Lock "A-CLASS®" Acetabular Poly Liner, Femoral Head Biolox Delta Ceramic/ Rim-Lock Biolox Delta Ceramic Liner, CoCr Femoral Head. The license holder is MicroPort Scientific India Pvt. Ltd.,, and it is classified as Device Class Class D. 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.

Free Database

CDSCO Registered

Class Class D

Total Hip System

UID: IMP/MD/2018/000146_08226695ea318b8832570f14edad039e_f9efa90e2570a6701edf101b6565e3c0

Brand Name

Profemur, Profemur Gladiator Classic, Profemur TL Classic, Procotyl L, Dynasty, Cancellous Bone Screw, Rim-Lock "A-CLASS®" Acetabular Poly Liner, Femoral Head Biolox Delta Ceramic/ Rim-Lock Biolox Delta Ceramic Liner, CoCr Femoral Head

License Holder

MicroPort Scientific India Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusioacetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; Correction of functional deformity; and, Revision procedures where other treatments or devices have failed. Rough grit blast surfaces and the hydroxyapatite and titanium plasma spraycoatings applied to implant surfaces are intended for uncemented arthroplasty.