ISO 13485 & CE Certified Contract Manufacturing

OEM & ODM Manufacturing Solutions

Custom Orthopedic Contract Manufacturing & Private Labeling for Global Healthcare Distributors

Government Recognized Facility
7,000+ sqm Facility High-Precision CNC Machining Center
ISO 13485 & CE Quality
100,000+ Implants / Month Automated Large-Scale Capacity
Global Export Excellence
700+ ODM Products Proven Surgical Product Library
Custom Private Labeling
End-to-End Solutions Laser Marking, Packaging & CE Support

Precision OEM Manufacturing for Global Orthopedic Brands

Zealmax Innovations Pvt. Ltd. is a government-recognized orthopedic manufacturing leader with over 18 years of clinical and engineering expertise. Operating from a state-of-the-art 7,000 square meter production facility, we specialize in high-precision Original Equipment Manufacturing (OEM) of orthopedic implants, trauma plates, pedicle screws, and specialized surgical instruments.

Our facility is equipped with multi-axis VMC and CNC machining centers, automated robotic positioning, and cleanroom packaging systems to achieve micrometer-level accuracy and defect-free production. Every implant undergoes 100% CMM dimensional testing and surface passivation to meet international ISO 13485:2016 and CE standards, offering global distributors exceptional reliability and cost efficiency.

7,000 sqm Manufacturing Plant
100,000+ Implants Monthly Capacity
50+ Countries Exported
OEM Orthopedic Implants Precision Machining Center
ODM Custom Orthopedic Design and Engineering

Turnkey ODM Custom Implant Design & Co-Development

Our Original Design Manufacturing (ODM) service bridges innovative surgical concepts and commercially viable medical devices. Supported by an established design portfolio of over 700+ implant variations, our bio-engineers work directly with orthopedic surgeons, hospital networks, and brand owners to engineer customized implants tailored to specific anatomical requirements.

From initial 3D CAD modeling and Finite Element Analysis (FEA) to rapid prototyping and mechanical fatigue testing, Zealmax Innovations manages the entire lifecycle of custom product creation, providing complete technical documentation and regulatory dossier support for international markets.

ODM Development Highlights:

  • 3D Anatomical Modeling: Biomechanical simulation and structural stress optimization.
  • Prototyping & FEA: Rapid sample fabrication and destructive/non-destructive fatigue testing.
  • Clinical & Regulatory Alignment: Technical files ready for CE, US FDA, and local market registration.

Medical-Grade Materials & Technical Standards

We source certified bio-materials exclusively from internationally accredited raw material suppliers to maintain clinical excellence.

Implants & Alloy Standards

Titanium Alloy (Ti-6Al-4V ELI / Grade 5): ISO 5832-3 compliant, offering high strength-to-weight ratio and bio-inertness for trauma, spine, and maxillofacial systems.

PEEK Optima: High-grade radiolucent polymer for interbody spine cages, cervical cages, and arthroscopy suture anchors.

Stainless Steel 316L / 316LVM: ISO 5832-1 medical steel for robust fracture fixation and reusable surgical instrument sets.

Surface Finishing & Finishing Options

• Type II Hard Anodization and Type III Color Anodization for dimensional coding and anti-galling performance.

• Electrochemical polishing, citric/nitric acid passivation, and ultrasonic multi-stage washing.

• High-precision fiber laser marking for customer logos, part numbers, lot identification, and GS1 UDI barcodes.

Partner with an ISO 13485 Certified OEM/ODM Manufacturer

Discover our complete range of certified orthopedic implants, custom engineering services, and international distribution support.

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