ISO 13485 & CE Certified Manufacturing

Trauma Implants

ISO & CE Certified Manufacturer
ISO 13485 & CE Mark Certified Compliant with International Medical Directives
High Quality Implants
Biocompatible Materials Medical Grade Titanium & Stainless Steel
Global Distribution
Global Export Network Serving 50+ Countries & Hospital Suppliers
OEM Custom Manufacturing
OEM & ODM Turnkey Solutions Custom Implant Engineering & Packaging

Orthopedic Trauma Implants Manufacturer & Global Supplier

Zealmax Innovations Pvt. Ltd. is a government-recognized, ISO 13485 and CE-certified manufacturer and exporter of precision-engineered orthopedic trauma implants. With over 18 years of clinical and manufacturing expertise, we deliver high-performance internal fixation devices engineered to accelerate patient recovery and maintain structural stability under stress.

Our trauma solutions are trusted by orthopedic surgeons, medical importers, distributors, and healthcare procurement agencies across North America, Latin America, Europe, Africa, the Middle East, and Southeast Asia. Built in state-of-the-art facilities utilizing Swiss CNC multi-axis machining and automated robotics, every implant undergoes rigorous multi-stage quality inspections to comply with strict international regulatory frameworks.

Complete Trauma Implants & Fixation Portfolio

Comprehensive anatomical plates, interlocking nails, bone screws, and instrument sets designed for small, large, and complex fracture management.

2.7mm Locking Compression Plates & Bone Screws

2.7 mm Plates & Screws

Anatomically contoured volar radius, clavicle, and hand/foot mini fragment plates designed for optimal screw engagement and low profile placement.

3.5mm Locking Compression Plates & Screws

3.5 mm Plates & Screws

Comprehensive reconstruction, T-plates, distal humerus, and proximal tibia locking compression plates engineered for versatile small fragment internal fixation.

Locking Compression Plates LCP

Locking Compression Plates

Advanced LCP technology providing angular stability, preserving periosteal blood supply, and minimizing soft tissue irritation in osteoporotic bone.

5.0mm Large Fragment Plates and Screws

5.0 mm Plates & Screws

Heavy-duty femoral, tibial shaft, and broad locking plates designed for high load-bearing anatomical fixation in major long-bone fractures.

Intramedullary Interlocking Nails PFN PFNA

Nail Implants & PFN Systems

Proximal Femoral Nails (PFN / PFNA), Tibial, and Femoral Interlocking Nails optimized for minimally invasive insertion and dynamic axial compression.

DHS DCS Dynamic Hip and Condylar Plates

DHS / DCS & Specialized Implants

Dynamic Hip Screw (DHS) and Dynamic Condylar Screw (DCS) systems providing rigid stabilization for trochanteric and supracondylar femur fractures.

Locking Screws Cortical and Cancellous

Locking Screws

Precision-threaded self-tapping cortical and cancellous locking screws engineered for maximum pull-out strength and precise angular stability.

Cannulated Screws and Non-Locking Screws

Non-Locking & Cannulated Screws

Standard cortical, cancellous, and Herbert-style cannulated screws for percutaneous fixation and compression of joint surfaces.

Technical Excellence & Engineering Standards

At Zealmax Innovations, raw material selection is critical to ensuring patient safety and implant survival. All trauma implants are manufactured using certified biocompatible materials that meet global standards:

Titanium Ti-6Al-4V ELI

Conforms to ASTM F136 / ISO 5832-3. Offers superior fatigue strength, low modulus of elasticity, and excellent biocompatibility for primary fixation.

Stainless Steel 316L

Conforms to ASTM F138 / ISO 5832-1. High corrosion resistance, mechanical strength, and ductility suitable for cost-effective trauma solutions.

Anodization & Surface Treatments

Type II anodic passivation treatment enhances surface wear resistance, reduces fretting corrosion, and provides color-coded sizing identification.

Implants Specifications Overview

Product Family Material Grade Key Features / Sizing Regulatory Compliance
Locking Plates (LCP) Titanium / Stainless Steel 316L 2.7mm, 3.5mm, 4.5mm / 5.0mm systems ISO 13485, CE Marked, US-FDA standard
Interlocking Nails Ti-6Al-4V ELI / SS 316L PFN, PFNA, Tibial & Femoral Nails (9mm - 12mm) ISO 13485, CE Marked
Cannulated Screws Titanium / SS 316L 3.5mm, 4.0mm, 4.5mm, 6.5mm, 7.3mm ISO 13485, CE Marked
Trauma Instrument Sets Medical Stainless Steel (AISI 420/304) Ergonomic color-coded quick-coupling handles ISO 13485, CE Certified

Global Partnership & B2B Distribution Solutions

We work directly with medical device importers, hospital contractors, government health ministries, and orthopedic brand owners worldwide. Our export capabilities ensure seamless delivery with comprehensive documentation to streamline national health registration:

  • Regulatory Support: Certificate of Analysis (COA), Free Sale Certificates (FSC), CE documentation, ISO certificates, and complete technical dossiers for fast country registration.
  • OEM / ODM Manufacturing: Private labeling, custom laser marking, custom tray configuration, and tailored packaging according to client specifications.
  • Quality Guarantee: 100% optical inspection under CMM and digital profile projectors before double-chamber sterile or non-sterile protective packaging.

Partner with a Leading Trauma Implants Manufacturer

Expand your product offerings with certified high-precision orthopedic trauma implants. Contact our international export department today for bulk catalog pricing, technical specifications, and distribution opportunities.

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ISO 13485 Certification ISO 13485 Certified
CE Mark Certification CE Marked Products
Quality Certification Quality Assured
Government Recognized Govt. Recognized
International Standards International Standards
Export Excellence Export Excellence