Medisplint Medisplint

Total Hip & Knee Replacement (THR/TKR) Solutions for Milan Market

Global Joint Reconstruction Implants & Orthopaedic Instruments Exporter. Supporting Milan's Advanced Orthopaedic Centers with CE Class III Certified Innovations.

Send Inquiry Now
18,500m²
Production Facility
1,200+
Supply Chain Partners
68
New Products Launched
ISO 13485
CE MDR Standards
Product Portfolio Focus

Primary Joint Replacement Implants

Explore our top clinically-proven joint reconstruction implants designed for exceptional bone preservation and long-term durability in primary hip and knee arthroplasty.

CANWELL Primary Acetabular Cup Titanium Coating

CANWELL Primary Acetabular Cup Total Hip Arthroplasty Artificial Hip Titanium Coating Prosthetics Joint Replacement

View Product Specifications
CANWELL Primary Femoral Titanium Stem

CANWELL Primary Femoral Titanium Stem Artificial Hip Ti HA Coated Prosthetics Joint Replacement Hip Replacement Class III

View Product Specifications
CANWELL Primary Ceramic Femoral Head

CANWELL Primary Ceramic Femoral Head Total Hip Arthroplasty Revision Modular Head Prosthetics Joint Replacement Class III CE

View Product Specifications
CANWELL TKR Knee Implants Arthroplasty

CANWELL TKR Knee Implants Arthroplasty Artificial Knee Joint CoCrMo Alloy Orthopedic Implants Primary Total Knee Replacement Kit

View Product Specifications
Local Market Insights

Milan Arthroplasty Demand & Clinical Standards

As the commercial capital of Italy and home to the Lombardy healthcare cluster—the region with the highest volume of orthopedic interventions in Italy—Milan represents a mature market demanding peak clinical efficacy. Renowned institutes like the Istituto Ortopedico Galeazzi, Gaetano Pini Hospital, and the Humanitas Research Hospital drive the local demand for advanced Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA) solutions.

Faced with an aging demographics and rising physical activity expectations among elderly cohorts, Milanese orthopedic surgeons demand high biological fixation implants (such as Titanium-Plasma Spray and Hydroxyapatite double coating) and high-flexion, ultra-wear-resistant knee components. Medisplint addresses these critical parameters by fabricating implants from premium ISO 5832 compliant materials that significantly mitigate risk of aseptic loosening and revision.

Medisplint Raw Materials Quality Control
Clinical Excellence

Addressing Global Orthopaedic Trends

We analyze global joint replacement data to engineers implants that reduce revision rates and maximize post-surgical mobility.

Advanced Osseointegration

Our cementless hip stems feature vacuum-sprayed rough Titanium coating combined with HA (Hydroxyapatite) to guarantee high primary stability, inducing faster bone growth and continuous biological anchorage.

Optimized Tribological Couples

Leveraging Biolox Delta ceramic heads paired with highly cross-linked polyethylene (XLPE) or dual mobility UHMWPE liners. Minimizes wear rates to less than 0.1 mm per year under standard gait cycles.

Ergonomic Instrumentation

Proprietary hip extractor and revision instrument kits. Reduces surgical time in complex cases, facilitating seamless stem explantation and precise modular alignment.

Production Mastery

Advanced Orthopaedic Manufacturing

From raw material testing to final cleaning and packing, Medisplint maintains complete control over the orthopedic manufacturing pipeline in our 18,500m² facility.

Slitting Raw Materials
Slitting & Material Preparation
CNC Machining
CNC Machining (High Precision)
Machining Operations
High-Speed Milling & Grinding
Inspection and Packing
Inspection & Cleanroom Packing
Slitting Machine
Industrial Slitting Systems
CNC Machining Center
CNC Multiaxis Machining Center
Wire Cutting Machine
Precision Wire-Cut EDM
CNC Lathe
Advanced CNC Lathe Operations
Medisplint CAD Engineering Design
Technical Roadmap

Material Science & Surface Morphology

Medisplint’s THR and TKR implants are engineered based on deep tribological and mechanical fatigue studies. We select medical grade Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and CoCrMo conforming to ISO 5832-4 to construct implants that meet high biocompatibility and yield strength parameters.

For modular hip stems, our taper geometry uses the industry-standard 12/14 taper, preventing taper lock and micro-motion wear. Knee femoral components are polished to a mirror finish (Roughness Average, Ra < 0.05 μm) using high-grade chemical mechanical planarization (CMP), mitigating abrasive wear on UHMWPE and vitamin-E enriched polyethylene liners during flexion and extension cycles.

Regulatory Assurance

Rigorous Testing & Regulatory Compliance

Our quality inspection team includes 42 certified inspectors running dynamic mechanical fatigue tests and dimensional analysis to meet EU MDR & CE Class III requirements.

Fatigue Tester
Dynamic Fatigue Testing
Tensile Tester
Tensile Strength Testing
Two Dimensional Measuring Instrument
2D Metrology Dimension Inspection
Bone Screw Performance Tester
Torque & Performance Analysis

CE Class III Certification & Hospital Audit Preparation

Under the EU MDR (Medical Device Regulation 2017/745), joint replacement implants are classified as high-risk Class III devices requiring comprehensive clinical evaluation reports (CER) and post-market clinical follow-up (PMCF) plans. Medisplint supports distributors in Milan and across Lombardy with fully documented technical dossiers, biocompatibility data (ISO 10993), packaging validation reports, and sterilization validation certificates.

  • ISO 13485:2016 Certified Quality Management System
  • 100% Traceability from raw material bar stock to sterile barrier pouch
  • Third-party laboratory validation for mechanical fatigue and wear analysis
Custom Solutions

OEM/ODM & Private Label Sourcing for European Distributors

Medisplint offers clinical-grade OEM/ODM services, allowing distributors to customize sizing profiles, bone-prosthetic interface designs, and surgical instruments. Supported by our team of 85 R&D engineers, we provide rapid prototyping and 3D modeling to tailor joint components specifically for localized patient morphologies or customized surgery pathways.

Our facility runs high-volume manufacturing lines capable of scaling production to support major public tenders in Europe. We establish long-term contract pricing models, allowing importers to bypass intermediaries, reduce landing costs by 30-40%, and build resilient, high-margin product pipelines under their proprietary brand names.

Medisplint Clean Testing Laboratory
Common Sourcing Questions

Orthopaedic Implants FAQ

Find detailed answers to key engineering, regulatory, and logistics questions from hospital procurement specialists and orthopaedic device distributors.

How does Medisplint ensure compliance with the strict CE MDR requirements for Class III implants?
Medisplint maintains a certified ISO 13485 quality management system. For all Class III hip and knee implants, we prepare comprehensive technical documentation (Annex IX/X), perform extensive biocompatibility testing (ISO 10993), run mechanical fatigue verification tests (ISO 7206 / ISO 14879), and establish a Post-Market Clinical Follow-up (PMCF) framework to ensure compliance with the European Medical Device Regulation (EU 2017/745).
What raw materials are used in the production of your femoral stems and acetabular cups?
We use medical-grade Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136 / ISO 5832-3 for cementless stems and acetabular cups, ensuring ideal mechanical properties and biocompatibility. For articulating joints, we utilize Cobalt-Chromium-Molybdenum (CoCrMo) alloy conforming to ISO 5832-4 and Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or highly cross-linked polyethylene (XLPE) for inserts to optimize wear resistance.
Do you support OEM manufacturing and private labeling for orthopedic distributors in Northern Italy?
Yes, Medisplint is an experienced OEM/ODM partner. We offer private labeling, tailored implant design adjustments, custom surgical instrument development, and cleanroom sterile packaging solutions. Our engineering department can customize sizing ranges to match the specific anatomical profiles of European patients.
What quality testing protocols are implemented in your facility?
Our quality assurance program is managed by 42 dedicated inspectors. We conduct 100% incoming material validation, In-Process Quality Control (IPQC), Final Quality Control (FQC) involving three-dimensional measuring instruments, surface finish roughness evaluation, bone screw torque/shear testing, and third-party laboratory verification for fatigue and tensile performance.
Instrument & Implant Modules

Surgical Instruments & Modular Implants

Premium Grade CoCrMo components, UHMWPE mobility inserts, and ergonomic surgical instrument kits optimized for primary and revision joint arthroplasty procedures.

CANWELL Stem Inserter Orthopaedic Instrument

CANWELL Stem Inserter Orthopaedic Joint Replacement Instrument Total Hip Arthroplasty Instruments Common Set

View Specs & Pricing
CANWELL Manual Orthopedic Hip Extractor

CANWELL Manual Orthopedic Hip Extractor T-Handle Acetabulum Instrument Set Hip Revision Instrument Set Hemi Arthroplasty Bipolar

View Specs & Pricing
CANWELL Hip Revision Instrument Set

CANWELL Hip Revision Instrument Set Hemi Arthroplasty Bipolar Total Hip Replacement Tool Femoral Stem Orthopedic Surgery Tools

View Specs & Pricing
CANWELL Tibial Base Plate Knee Prosthesis

CANWELL CoCrMo Alloy Tibial Base Plate Arthroplasty Prosthetic Knee Joint Prosthesis TKA Solution Primary Revision Total Knee

View Specs & Pricing
CANWELL Femoral Component Knee Prosthesis

CANWELL Femoral Component Arthroplasty Prosthetic Knee Joint Prosthesis Artificial PS CoCrMo Primary Total Knee Replacement Kit

View Specs & Pricing
CANWELL Total Hip Ceramic Replacement

CANWELL Arthroplasty Total Hip Ceramic Replacement Cemented Prosthesis Corail Femoral Stem Bipolar Prosthesis Instrument Set

View Specs & Pricing
CANWELL Bipolar Head Total Hip Arthroplasty

CANWELL Primary Femoral Bipolar Head CoCrMo UHMWPE Total Hip Arthroplasty Modular Head Prosthesis Joint Replacement Class III

View Specs & Pricing
CANWELL Cementless Femoral Stem

CANWELL Primary Cementless Femoral Stem CoCrMo Class III Artificial Hip Prosthetics Joint Replacement Total Hip Replacement CE

View Specs & Pricing

Partner with an Industry-Leading Orthopedic Manufacturer

Get in touch with our product application specialists to discuss technical compliance, local distribution tenders, or OEM options for Milan and broader European markets.

Send Inquiry Now