About Us

Empowering Global Healthcare through Precision Orthopedic Engineering

Leading ISO 13485 & CE Certified Orthopedic Implants Manufacturer

Remak Ortho Pvt Ltd is an Indian FDA approved, WHO-GMP, CE, and ISO 13485:2016 certified medical device company headquartered in Ahmedabad, India. Incorporated in 2012, our organization has established itself as a premier global partner in the design, precision manufacturing, and export of high-grade generic and custom orthopedic implants and surgical instruments.

With over a decade of continuous technological innovation, we serve healthcare institutions, orthopedic distributors, government procurement bodies, and surgical specialists across more than 30 countries worldwide. Our commitment to strict quality management guarantees that every product delivers dependable surgical performance, optimal biocompatibility, and long-term implant stability.

Corporate Quality Credentials

  • International Certifications: ISO 13485:2016, CE Certified, Indian FDA Approved, WHO-GMP Compliant.
  • Global Supply Reach: Export footprint expanding across 30+ countries in Europe, Asia, Africa, and Latin America.
  • In-House Infrastructure: Advanced multi-axis CNC milling, VMC centers, and Swiss-type automatic sliding head technology.
  • Biocompatible Materials: Medical-grade Stainless Steel (SS 316L, SS LVM), Titanium Grade 5 (Ti-6Al-4V ELI), and PEEK polymers.
  • OEM & ODM Capabilities: Custom surgical solutions engineered for global healthcare brands.

Precision Manufacturing & Strict Quality Control

To maintain uncompromised mechanical strength, dimensional accuracy, and zero-defect quality, all Remak Ortho products are produced within controlled manufacturing environments using certified medical-grade alloys imported from accredited global suppliers.

Advanced Machining Technology

Equipped with multi-axis CNC machines, 5-axis VMC machining centers, and automated Swiss sliding head lathes, achieving micrometric precision across intricate spinal and trauma implant contours.

Certified Raw Materials

Implants are manufactured strictly adhering to ISO 5832 and ASTM F136 specifications using SS 316L, Stainless Steel LVM (Low Carbon Vacuum Melt), Titanium Alloy Grade 5, and implant-grade PEEK.

100% Quality Assurance

Comprehensive inspection protocols featuring Coordinate Measuring Machines (CMM), optical profile projectors, surface roughness analyzers, passivators, and full batch material traceability.

Orthopedic Implant Solutions for Global B2B Partners

1. Trauma Fixation Systems

Comprehensive trauma range including anatomically contoured locking plates, standard non-locking plates, cortical & cancellous bone screws, cannulated screws, interlocking intramedullary nails (Femoral, Tibial, Humeral), Kirschner wires, Steinmann pins, and bipolar hip prostheses.

2. Spinal Implants & Reconstruction

Advanced spine care product lines including pedicle screw systems, PEEK cervical cages, lumbar interbody cages (TLIF, PLIF), anterior cervical plate systems, posterior cervical fixation systems, and specialized spinal stabilization instruments.

3. Arthroscopy Implants & Soft Tissue

High-performance arthroscopic implants for knee and shoulder joint reconstruction, including ACL/PCL interference screws, suture anchors, fixation buttons, and dedicated soft tissue repair instrumentation sets.

4. Surgical Instruments & Power Systems

Complete ergonomic surgical instrument sets tailored for trauma, spinal, and joint surgeries, alongside heavy-duty surgical power tool systems, reamers, drill bits, and alignment guides engineered for OR reliability.

Our Quality Policy & Mission Statement

At Remak Ortho Pvt Ltd, our core mission is to enhance patient mobility and empower surgeons around the world by delivering certified, biocompatible, and high-precision orthopedic solutions at sustainable global pricing. We assist international procurement partners with complete technical documentation, Certificates of Analysis (COA), Free Sale Certificates (FSC), fast lead times, and seamless international freight logistics.