Bipolars Hip prosthesis

The Bipolars Hip prosthesis from JS Medimax Private Limited is a bipolar hemiarthroplasty implant manufactured from SS 316 stainless steel, an austenitic grade with molybdenum addition for improved pitting corrosion resistance in saline physiological environments. The head diameters span 37mm to 55mm, accommodating a range of acetabular morphologies, with a stem length of 163mm and stem thickness of 10mm. The bipolar design features an articulating outer shell and inner bearing, allowing dual motion that reduces shear stress on the acetabular cartilage compared to unipolar alternatives.

SS 316L, the low-carbon variant of 316, is standard for orthopaedic implants to minimise sensitisation during welding or forging, though the source specifies SS 316 without confirming carbon content. The 135-degree operational angle referenced in the source relates to the range of motion before impingement or dislocation risk becomes critical. Typical bipolar head articulation in this category employs ultra-high molecular weight polyethylene (UHMWPE) or similar polymer liners between the inner and outer shells, though the source does not specify liner material or sterilisation method. Buyers should confirm whether heads are forged, cast, or machined from bar stock, and whether surface finish meets Ra thresholds for biological acceptance.

This prosthesis is indicated for displaced femoral neck fractures, avascular necrosis, and certain post-traumatic hip pathologies in patients where total hip replacement is contraindicated or unnecessary. The bipolar configuration suits older, less active patients who require stable, low-maintenance articulation. Importers should verify whether JS Medimax offers trial heads, broach sets, and rasp systems with matching geometries, and confirm regulatory clearance status for target markets before committing to clinical trials or hospital tenders.

JS Medimax Private Limited is located at Office Number 73, Gulabi Bagh Truck Market, Delhi 110007, India, placing it in a commercial district of North Delhi rather than a dedicated medical device manufacturing zone. The supplier is classified as an imported-tier account with a harbor trust tier. Its response rate is 0.00 percent and average response time is zero hours, meaning no recent buyer engagement data is available. The listing does not disclose manufacturing facility location, cleanroom classification, design history file status, or regulatory affairs personnel.

The profile does not specify ISO 13485 certification, CE marking, or US FDA registration, despite the source description referencing ISO and FDA certifications without detail. No information is provided on production capacity, sterility assurance level (SAL), biocompatibility testing per ISO 10993, or clinical follow-up data. The company name suggests private limited status under Indian company law, but incorporation date, authorised capital, and directorship are not stated. Buyers must request the certificate of incorporation, manufacturing licence under the Drugs and Cosmetics Act, and any GMP audit reports directly from JS Medimax.