Maka Medical Surgical
Maka Medical Surgical
Premium OEM/ODM manufacturing engineered using medical-grade Titanium and PEEK biomaterials.
Maka Medical Technology Co., Ltd. is a clinical-grade implantable device manufacturer based in Changzhou City, Jiangsu Province, China. With over a decade of dedication to orthopedic excellence, we specialize in high-end design, CNC machining, surface finishing, and quality control systems for trauma, spine, and joint applications.
Our core orthopedic and trauma device range covers: trauma bone plates, anatomical locking screws, intramedullary interlocking nails, pedicle screws, anterior cervical plates, and PEEK cervical and lumbar fusion cages.
By leveraging advanced Swiss precision machining equipment, automated validation protocols, and comprehensive cleanroom operations, we serve as an authoritative OEM/ODM partner for medical device brands, veterinary surgical institutes, and international healthcare distributors worldwide.
Expert insights into regulatory evolution, materials innovation, and supply chain strategies.
The global implantable device market is transitioning from traditional stainless steel to highly biocompatible metals and engineering plastics. High-strength Titanium Alloys (Ti-6Al-4V ELI) and PEEK (Polyetheretherketone) represent the modern clinical standard. PEEK cages provide an elastic modulus closely matching human cortical bone, reducing stress shielding and promoting accelerated osseointegration.
International procurement departments require flawless validation. Class III medical devices mandate complete material traceability, validated ultrasonic washing, and cleanroom bioburden controls. Maka Medical implements standardized material certs (ASTM F136 / ASTM F2026), assuring compliance with EU MDR and US FDA regulatory pathways.
Implant success depends heavily on the interface between implants and instruments. High-performance stainless steel (such as surgical grade 440C or 17-4 PH) is utilized for drill bits and quick couplings. Proper torque transfer, thread geometry (such as variable pitch in cannulated headless screws), and wear resistance prevent hardware failure during intraoperative fixation.
Maka Medical Technology Co., Ltd. provides a streamlined manufacturing process from raw material bar stock to sterile-ready packaged products. Our integrated production solutions include:
Every raw material batch (Titanium Grade 5 Eli / PEEK Optima) undergoes mass spectrometry, mechanical load limits testing, and chemical composition validation. We maintain record files for 10+ years to guarantee post-market clinical traceability.
Ensuring compliance, accelerating time-to-market, and future-proofing orthopedic systems.
We supply complete technical documentation, including raw material mill certificates, design drawings, cleanroom validation reports, and sterilization test data. This speeds up registration with regional health ministries (FDA, CE, SFDA, PMDA).
Our engineering team works directly with your R&D department. Using CAD/CAM modeling and FEA (Finite Element Analysis) stress simulations, we optimize custom implant profiles before volume production begins, minimizing design risk.
As smart orthopedics evolve, we are integrating active osteoinductive surfaces, biodegradable composite alloys, and customized, patient-matched structures into our manufacturing capabilities.
Engineered for high load-bearing stability and anatomical matching.
Technical answers to common engineering, regulatory, and quality control questions.
We use medical-grade Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136/ISO 5832-3 standards. For spinal fusion cages, we use implant-grade PEEK (Polyetheretherketone) complying with ASTM F2026. Material certification and traceability reports from raw stock to finished goods are provided with every delivery.
Yes, we provide full ODM and OEM services. We can customize screw thread pitches (such as double-lead or variable-angle locking screws), adjust locking plate profiles, and design specialized surgical instrumentation kits (such as tibial and femoral nail installation sets) using your specific CAD files.
Our manufacturing includes validated ultrasonic cleaning systems, chemical passivation to enhance corrosion resistance, and bioburden inspections. All implants are packaged in ISO Class 7 (Class 10,000) cleanrooms. We provide non-sterile products for hospital sterilization or pre-packaged sterile implants sterilized via Gamma Irradiation or Ethylene Oxide (EO).
Our factory operates under ISO 13485 quality management systems for medical devices. We employ automated CMM (Coordinate Measuring Machines), optical comparators, and mechanical testing systems to verify that dimensional tolerances and load limits match clinical requirements.
Yes. We supply a comprehensive line of veterinary-specific orthopedic implants, including PEEK TLIF spinal cages, micro-locking plates, and specialized veterinary PFNA interlocking nails. These are designed to withstand the varied biomechanical stresses found in different animal species.
