SGS onsite-verified orthopedic manufacturer · CE (MDR / 93/42/EEC) implants · OEM & ODM
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Orthopedic Implant Manufacturing Facilities & QC Process

Precision CNC Machining, Penetrant Testing & ISO Class 8 Cleanroom Packaging at Zhejiang INAR Medical Co., Ltd.

Enterprise Overview

29,523 m² State-of-the-Art Production Base

At Zhejiang INAR Medical Co., Ltd., we specialize in end-to-end orthopedic manufacturing. With over 22 years of clinical engineering expertise and a dedicated staff of 632 professionals, our facility is equipped with modern multi-axis CNC machines, automated polishing units, non-destructive testing labs, and ISO Class 8 aseptic packaging cleanrooms.

Every trauma locking plate, intramedullary nail, spinal pedicle screw, and sports medicine implant undergoes a rigorous 13-stage manufacturing process compliant with CE MDR, ISO 13485, and EU Directive 93/42/EEC standards.

Quality Control Highlights

Our quality management system guarantees batch-to-batch consistency and full material traceability for global distributors.

100% Penetrant NDTZero surface defects assurance
ISO CleanroomClass 8 aseptic packaging
Medical TitaniumGrade 4 & Ti-6Al-4V ELI
Fatigue TestedIn-house biomechanical testing
Standard Operating Procedure

13-Stage Orthopedic Production Workflow

From certified raw bar stock to sterile packing, each production step is subject to strict in-process quality control (IPQC).

01 Medical grade titanium raw material inspection at Zhejiang INAR Medical Co., Ltd.

Raw Material Receiving

100% inspection of medical-grade titanium alloy (Ti6Al4V ELI) and PEEK bars with chemical certificate verification.

02 Longitudinal cutting lathe for orthopedic implant raw stock

Longitudinal Cutting

Precision sizing of bar stock using high-speed automatic longitudinal cutting machines to ensure accurate blank dimensions.

03 Multi-axis CNC machining of trauma locking plates and screws

CNC Machining

High-precision multi-axis CNC milling and turning for anatomical plate contours, locking threads, and screw flutes.

04 Automated surface polishing of orthopedic devices

Surface Polishing

Deburring and mirror polishing to eliminate stress concentration points and improve biocompatibility.

05 Ultrasonic washing stage 1 for medical devices

Ultrasonic Washing I

Multi-stage ultrasonic degreasing and cleaning to remove machining oil and particulate residues.

06 Precision grinding machine for orthopedic surgical tools and implants

Grinding & Refining

Micro-grinding of edge profiles and instrument tips to ensure precise mechanical tolerances.

07 Sand-blasting machine for orthopedic implant surface matte finishing

Sand-Blasting

Controlled micro-bead blasting to achieve specified surface roughness for optimal bone-implant interface adhesion.

08 Fluorescent penetrant testing for orthopedic implant micro-crack detection

Penetrant Testing (NDT)

Fluorescent dye penetrant inspection under UV light to detect micro-cracks or surface discontinuities.

09 Anodizing color coding line for titanium plates and screws

Electrochemical Anodizing

Type II anodizing and vivid color coding to facilitate quick intraoperative identification during surgery.

10 Secondary ultrasonic deionized water cleaning stage

Ultrasonic Washing II

Pure deionized water ultrasonic rinsing for final pyrogen and particulate decontamination prior to packaging.

11 Outgoing Quality Control (OQC) visual and dimensional inspection

Outgoing Quality Control (OQC)

Final optical coordinate measurement and 100% sampling audit before authorization for packaging.

12 ISO Class 8 Aseptic packing cleanroom environment

Aseptic Cleanroom Packing

Sealing implants in sterile blister packs or protective bags inside controlled ISO Class 8 (100,000 class) cleanrooms.

13 Final packaging line for export orthopedic implants

Final Packaging Line

Custom OEM/ODM box labeling, UDI barcode printing, and protective packaging compliant with global export standards.

✓ Finished orthopedic products storage warehouse

Warehouse Storage

Climate-controlled inventory storage ensuring safety and rapid worldwide dispatch to B2B distributors.

Production Infrastructure

Machinery & Quality Testing Laboratory

Zhejiang INAR Medical Co., Ltd. invests continuously in high-precision Japanese and European machining technology and advanced biomechanical testing instruments.

Longitudinal Cutting Lathe at Zhejiang INAR Medical Co., Ltd.

Longitudinal Cutting Lathe

High-efficiency automatic bar cutting lathe ensuring uniform stock preparation for locking screws and pins.

High precision multi-axis CNC machining center

Multi-Axis CNC Lathes

Swiss-type precision automatic CNC lathes capable of sub-micron machining tolerances for intricate spinal and trauma implants.

Automated implant surface polishing machine

Polishing Machinery

Automated polishing machinery providing ultra-smooth surface finishing to prevent soft tissue irritation.

Industrial ultrasonic washing unit for medical implants

Ultrasonic Washing Unit

Multi-tank ultrasonic washing equipment with automated basket agitation and temperature controls.

Precision grinding machine for surgical instruments

Precision Grinding Machine

Centerless and surface grinding machinery designed for high-concentricity intramedullary nails and k-wires.

Automated sand-blasting machine for titanium implants

Sand-Blasting Machine

Enclosed sand-blasting system for uniform titanium anodizing preparation and enhanced osseointegration micro-textures.

Electrochemical titanium anodizing machine

Anodizing System

Computerized titanium anodizing setup delivering stable oxide layers, color uniformity, and corrosion resistance.

Aseptic cleanroom packaging facility

Aseptic Packing Environment

HEPA-filtered cleanroom equipped with automatic thermal sealing machines for sterile barrier integrity.

Penetrant testing inspection room for non-destructive testing

Penetrant Testing Room

Darkroom station dedicated to non-destructive fluorescent liquid penetrant inspection of structural load-bearing components.

Mechanical fatigue and endurance tester for orthopedic implants

Mechanical Endurance Tester

Biomechanical dynamic fatigue testing machine to validate cyclic loading, bending strength, and screw pull-out forces.

Packaging accelerated aging tester for shelf life validation

Accelerated Aging Tester

Environmental chamber testing sterile packaging seals under accelerated heat and humidity to confirm shelf-life validity.

Rigorous International Quality Compliance

Zhejiang INAR Medical Co., Ltd. operates in full compliance with ISO 13485 quality management systems. Our trauma, spine, and sports medicine product lines hold CE certifications under EU MDR and Medical Device Directive 93/42/EEC.

  • Complete Raw Material Traceability (Heat Numbers & Mill Certificates)
  • Onsite Assessment Verified by SGS Group
  • Full Support for Regulatory Registration & Hospital Tenders
100% In-House Manufacturing & Inspection

Nothing critical is outsourced. We guarantee consistent manufacturing standards from blank cutting to shipment.

Partner with a Reliable Orthopedic Manufacturer

Looking for a certified OEM/ODM manufacturing partner for trauma plates, intramedullary nails, pedicle screws, or sports medicine devices? Contact our technical sales team for engineering support and factory audits.

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