Sharma Orthopedic is a global manufacturer and exporter of ISO 13485 & CE certified Radial Head Replacement Implants. Engineered using high-purity medical stainless steel and titanium alloy, our prostheses provide stable joint kinematics, anatomical load sharing, and long-term durability for severe elbow fractures and degenerative joint disorders.
Designed with a monopolar, single-piece intramedullary stem that simplifies insertion while ensuring solid stability across the radiohumeral and proximal radioulnar joints. Ideal for primary joint preservation and non-reconstructable radial head fractures.
Features interchangeable heads and stems to accurately match complex anatomical variations. Offers smooth self-alignment capabilities within the radial neck, reducing friction against the humerus capitellum during flexural and rotational movements.
The radial head plays a critical role as a primary lateral stabilizer of the elbow joint. When comminuted Mason Type III or Type IV fractures occur, restoring native biomechanics through primary internal fixation is often impossible. Sharma Orthopedic's Radial Head Prosthesis delivers smooth articular tracking and minimizes the risk of valgus instability or proximal migration of the radius.
| Specification Parameter | Technical Details |
|---|---|
| Primary Material | Stainless Steel 316LVM / ISO 5832-1 & Titanium Alloy |
| Implant Configurations | Fixed Monopolar & Modular Bipolar Systems |
| Fixation Type | Cemented & Press-Fit Uncemented Options |
| Head Diameters | Multiple Anatomical Sizes (18mm - 24mm) |
| Stem Diameters | Proportional Sizing Options for Intramedullary Fit |
| Quality Certifications | ISO 13485:2016, CE Mark, WHO-GMP Compliant |
| Packaging | Double-Sterile Protective Blister Packaging |
Operating from a 62,000+ sq. ft. state-of-the-art facility equipped with 5-axis CNC machines and cleanroom sterile packaging lines in Gujarat, India, Sharma Orthopedic supplies hospital networks, government health ministries, and medical distributors across 50+ countries with uncompromised quality assurance.
Radial head replacement is indicated for severe comminuted radial head fractures (Mason Type III/IV), non-reconstructable traumatic elbow dislocations, osteoarthritis, rheumatoid arthritis, or acute elbow revision surgeries where native bone reconstruction is impossible.
We manufacture both Fixed (Monopolar) and Modular Radial Head Prostheses. Fixed implants provide a robust single-piece stem design, while Modular implants allow intraoperative customization with independent stem and head sizing to match patient anatomy.
Yes. Sharma Orthopedic supplies complete, ergonomic surgical trial sets including reamers, rasps, sizing gauges, and insertion instruments tailored to ensure predictable surgical technique and precise implant positioning.
Our entire manufacturing process complies with ISO 13485:2016 quality management systems and CE certification standards. Every batch undergoes strict dimensional verification, material testing, and non-destructive testing prior to dispatch.
Partner with a trusted orthopedic implant manufacturer. Contact our international sales department for bulk pricing, catalog distribution, and regulatory documentation.
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