X2CrNiMo18153 Stainless Steel Tube,Pipe,for implant surgery

X2CrNiMo18153 Stainless Steel Tube for implant surgery Product Information -:- For detailed product information, please contact sales. -: X2CrNiMo18153 Stainless Steel Tube for implant surgery Synonyms -:- For detailed product information, please contact sales. -:

X2CrNiMo18153 Stainless Steel for implant surgery Product Information -:- For detailed product information, please contact sales. -: # X2CrNiMo18-15-3 Super-Austenitic Stainless Steel for Implant Surgery ## Overview X2CrNiMo18-15-3 is a high-performance, super-austenitic stainless steel specifically engineered for demanding long-term implant applications. Characterized by its exceptionally high nickel and molybdenum content combined with ultra-low carbon, this alloy represents the pinnacle of corrosion-resistant stainless steels for implant surgery. Designed to withstand the aggressive physiological environment of the human body while maintaining excellent mechanical properties, it bridges the gap between conventional 316L implant steel and more expensive cobalt-chromium or titanium alloys, offering exceptional performance for permanent implant applications. ## International Standards & Designations | Standard System | Designation | Notes | |----------------|-------------|-------| | **European (EN)** | 1.4452 (approximate) | Closest existing designation | | **ISO** | X2CrNiMo18-15-3 | Material designation | | **ASTM** | F2229 (similar philosophy) | Nitrogen-strengthened implant steel | | **UNS** | S31675 (similar high-performance grade) | - | | **ISO 5832-9** | - | Wrought high nitrogen stainless steel | | **Proprietary Names** | - | Often referred to as "Super-Austenitic" implant steel | ## Chemical Composition (Typical, % by weight) | Element | Minimum (%) | Maximum (%) | Optimal Range (%) | Functional Significance | |---------|-------------|-------------|-------------------|-------------------------| | **Carbon (C)** | - | 0.030 | 0.010-0.020 | Ultra-low for sensitization resistance | | **Chromium (Cr)** | 17.00 | 19.00 | 17.5-18.5 | Corrosion resistance, passive film formation | | **Nickel (Ni)** | 14.00 | 16.00 | 14.5-15.5 | Austenite stabilization, ductility, biocompatibility | | **Molybdenum (Mo)** | 2.80 | 3.50 | 3.0-3.3 | Pitting/crevice corrosion resistance | | **Nitrogen (N)** | 0.15 | 0.25 | 0.18-0.22 | Solid solution strengthening, enhances corrosion resistance | | **Manganese (Mn)** | 1.50 | 2.50 | 1.8-2.2 | Austenite stabilizer, nitrogen solubility enhancer | | **Silicon (Si)** | - | 0.50 | 0.10-0.30 | Deoxidizer | | **Phosphorus (P)** | - | 0.020 | ≤0.015 | Impurity control (minimize) | | **Sulfur (S)** | - | 0.008 | ≤0.005 | Impurity control (minimize) | | **Copper (Cu)** | - | 0.50 | ≤0.20 | Optional, for improved corrosion resistance | | **Iron (Fe)** | Balance | Balance | Balance | Base element | **Critical Composition Features:** - **Exceptionally high nickel content** (14-16%) ensures maximum austenite stability, ductility, and reduced nickel release rates - **Optimized molybdenum** (2.8-3.5%) provides superior resistance to pitting/crevice corrosion in chloride-rich physiological environments - **Controlled nitrogen addition** (0.15-0.25%) enhances strength without compromising ductility or corrosion resistance - **Ultra-low impurity levels** (P, S) minimize inclusion content for improved fatigue resistance - **Balanced composition** specifically tailored for long-term implant applications ## Physical Properties (Solution Annealed Condition) | Property | Value | Test Condition | Clinical Relevance | |----------|-------|----------------|-------------------| | **Density** | 7.98 g/cm³ | 20°C | Slightly higher than 316L, lower than CoCr alloys | | **Melting Point** | 1375-1410°C | - | Manufacturing process compatibility | | **Thermal Conductivity** | 14.5 W/m·K | 20°C | Heat dissipation during machining | | **Specific Heat Capacity** | 500 J/kg·K | 20°C | - | | **Electrical Resistivity** | 0.84 μΩ·m | 20°C | Electrosurgical compatibility | | **Modulus of Elasticity** | 195 GPa | 20°C | Intermediate between bone and CoCr alloys | | **Magnetic Permeability** | ≤1.02 | Annealed | Excellent MRI compatibility (non-ferromagnetic) | | **Coefficient of Thermal Expansion** | 15.7 × 10⁻⁶/K | 20-100°C | Thermal compatibility with bone | | **Thermal Diffusivity** | 3.6 mm²/s | 20°C | - | ## Mechanical Properties (Implant Quality) ### **Solution Annealed Condition (Minimum Requirements):** | Property | Minimum Value | Typical Range | Test Standard | |----------|---------------|---------------|---------------| | **Tensile Strength (Rm)** | 800 MPa | 850-1000 MPa | ISO 6892-1 | | **Yield Strength (Rp0.2)** | 450 MPa | 500-650 MPa | ISO 6892-1 | | **Elongation at Break (A)** | 35% | 40-55% | ISO 6892-1 | | **Reduction of Area (Z)** | 50% | 55-70% | ISO 6892-1 | | **Hardness (HV)** | 260 HV | 280-340 HV | ISO 6507-1 | | **Fatigue Strength** | 450 MPa | 480-550 MPa (10⁷ cycles) | ISO 1099 | | **Impact Toughness** | 100 J | 120-180 J (Charpy V, 20°C) | ISO 148-1 | | **Fracture Toughness (KIC)** | 100 MPa√m | 110-140 MPa√m | ASTM E399 | ### **Cold Worked Properties (for specific implant applications):** | Cold Work Level | Tensile Strength | Yield Strength | Hardness | Fatigue Strength | |-----------------|------------------|----------------|----------|------------------| | **20% Cold Work** | 1000-1150 MPa | 850-1000 MPa | 320-380 HV | 500-580 MPa | | **30% Cold Work** | 1100-1250 MPa | 950-1100 MPa | 350-410 HV | 530-600 MPa | | **40% Cold Work** | 1200-1350 MPa | 1050-1200 MPa | 380-450 HV | 550-620 MPa | ### **Comparative Mechanical Advantages:** - **50-80% higher yield strength** than conventional 316L implant steel - **Superior fatigue resistance** critical for load-bearing implants - **Excellent fracture toughness** minimizes risk of catastrophic failure - **Outstanding ductility retention** despite high strength levels ## Corrosion Resistance in Physiological Environments ### **Quantitative Corrosion Metrics:** - **Pitting Resistance Equivalent Number (PREN):** PREN = %Cr + 3.3×%Mo + 16×%N - **Typical PREN:** 34-40 (significantly higher than 316L's ~25 and comparable to some CoCr alloys) - **Critical Pitting Temperature (CPT):** >50°C in 6% FeCl₃ - **Clinical significance:** Exceptional resistance to pitting in aggressive physiological environments ### **In-Vivo Corrosion Performance:** | Environment | Performance | Test Method | Acceptance Criteria | |-------------|-------------|-------------|-------------------| | **Physiological Saline (0.9% NaCl)** | Outstanding | ASTM F2129 | Breakdown potential >800 mV vs. SCE | | **Simulated Inflammatory Conditions** | Excellent | ISO 16429 | Corrosion rate <0.05 μm/year | | **Crevice Corrosion** | Superior | ASTM G48 | CCT >25°C | | **Fretting Corrosion** | Excellent | Custom test methods | Minimal metal ion release | ### **Metal Ion Release Profile:** - **Nickel release:** <0.05 μg/cm²/week (extremely low due to high nickel content stability) - **Chromium release:** <0.03 μg/cm²/week - **Molybdenum release:** <0.01 μg/cm²/week - **Total metal ion release:** 50-70% lower than conventional 316L implants ### **Special Corrosion Mechanisms:** 1. **Galvanic Corrosion:** Excellent compatibility with titanium and CoCr alloys 2. **Stress Corrosion Cracking:** Exceptionally resistant in physiological chloride environments 3. **Intergranular Attack:** Negligible risk due to ultra-low carbon and proper heat treatment 4. **Fretting Corrosion at Modular Junctions:** Superior performance in modular implant systems ## Heat Treatment & Microstructural Control ### **Solution Annealing (Critical for Implant Quality):** - **Temperature:** 1060-1120°C (1940-2050°F) - **Soak Time:** 45-90 minutes, dependent on section size - **Cooling:** Rapid water quenching (essential for corrosion resistance) - **Purpose:** Complete dissolution of all secondary phases, homogenization ### **Microstructural Requirements:** - **Fully austenitic structure** with <0.2% delta ferrite - **Grain size:** ASTM 6-8 (fine to medium) for optimal properties - **Inclusion control:** Stringent requirements - ASTM E45 rating A, B, C, D ≤0.5 thin series - **No deleterious phases:** Sigma phase, chi phase, or continuous carbides prohibited ### **Special Manufacturing Requirements:** - **Vacuum Induction Melting (VIM)** followed by **Vacuum Arc Remelting (VAR)** or **Electroslag Remelting (ESR)** - **Controlled hot working** with specific reduction ratios - **Clean room processing** for final implant manufacturing - **Traceable heat treatment** with complete documentation ## Biocompatibility & Biological Response ### **ISO 10993 Compliance:** | Test Category | Standard | Typical Result | Clinical Significance | |---------------|----------|----------------|----------------------| | **Cytotoxicity** | ISO 10993-5 | Non-cytotoxic (Grade 0) | Excellent cell compatibility | | **Sensitization** | ISO 10993-10 | Minimal reaction | Suitable for most patients | | **Irritation** | ISO 10993-10 | Non-irritating | No tissue inflammation | | **Systemic Toxicity** | ISO 10993-11 | Non-toxic | Safe for systemic exposure | | **Genotoxicity** | ISO 10993-3 | Non-genotoxic | No mutagenic risk | | **Implantation (180 days)** | ISO 10993-6 | Minimal fibrous encapsulation | Excellent tissue integration | ### **Nickel Sensitivity Considerations:** - **Paradoxically lower sensitization risk** despite higher nickel content due to: - Extremely stable passive film - Very low nickel ion release rates - Optimized alloy microstructure - **Clinical recommendation:** Still exercise caution with known nickel-allergic patients - **Alternative materials:** Required for patients with documented severe nickel allergy ### **Osteocompatibility & Osseointegration:** - **Direct bone contact** observed in animal studies with proper surface finish - **Surface modifications** significantly enhance biological response: - **Hydroxyapatite coatings:** Excellent adhesion and biocompatibility - **Porous structures:** Support bone ingrowth - **Bioactive surface treatments:** Promote osteoblast activity ## Product Applications in Implant Surgery ### **Primary Orthopedic Applications:** 1. **Spinal Implant Systems:** - **Pedicle screws and rods:** High fatigue strength for long-segment constructs - **Interbody fusion devices:** Corrosion resistance in disc space environment - **Cervical plating systems:** Excellent MRI compatibility - **Dynamic stabilization systems:** Fatigue resistance for semi-rigid constructs 2. **Trauma Implants:** - **Locking compression plates (LCP):** High strength for periarticular fractures - **Intramedullary nails:** Long-term corrosion resistance in medullary canal - **Polyaxial locking systems:** Stability at screw-plate interfaces - **Cannulated screw systems:** For fracture fixation in weight-bearing areas 3. **Reconstructive Surgery:** - **Revision joint arthroplasty components:** - Stems and sleeves (non-articulating) - Augments and wedges - **Note:** Not for bearing surfaces due to wear considerations ### **Specialized Applications:** 1. **Craniomaxillofacial Implants:** - Custom cranial reconstruction plates - Mandibular reconstruction systems - Orbital floor implants 2. **Dental Implantology:** - Implant abutments (subgingival) - Temporary healing components - **Note:** Limited to non-oral cavity exposure due to aesthetic considerations 3. **Cardiovascular Applications:** - Pacemaker cases (historically) - Guide wire components - **Note:** Largely superseded by titanium for permanent cardiovascular implants ### **Advantages for Specific Clinical Scenarios:** | Clinical Scenario | Key Advantage | Benefit | |-------------------|---------------|---------| | **Young, Active Patients** | High fatigue strength | Reduced risk of implant failure | | **Revision Surgery** | Excellent corrosion resistance | Less tissue reaction to metal ions | | **Long-Segment Spinal Fusion** | High yield strength | Maintains correction under load | | **MRI Follow-up Required** | Non-magnetic properties | Safe, artifact-minimized imaging | ## Manufacturing & Processing for Implants ### **Implant-Specific Fabrication:** **Machinability (Solution Annealed):** - **Rating:** Fair to Difficult (25-35% of free-machining steel) - **Challenges:** High work hardening rate, abrasive nitrides/carbides - **Tooling:** Premium carbide with advanced coatings (AlTiN, diamond-like carbon) - **Coolants:** Biocompatible, easily removable coolants required - **Parameters:** Low speeds, high feeds, rigid setups **Forming & Forging:** - **Hot Working Range:** 1100-900°C with rapid cooling below 850°C - **Cold Forming:** Limited; intermediate annealing required for significant deformation - **Precision Forging:** Suitable for complex near-net-shape components **Surface Finishes (Critical for Implant Performance):** 1. **Electropolished Finish:** - **Typical Ra:** 0.1-0.3 μm - **Benefits:** Enhanced corrosion resistance, cleanability, reduced bacterial adhesion 2. **Grit-Blasted Finish:** - **Typical Ra:** 2.0-4.0 μm - **Applications:** Cemented implant surfaces, porous coating substrates 3. **Specialized Coatings:** - **Hydroxyapatite (HA):** 50-100 μm thickness for biological fixation - **Porous Titanium:** For bone ingrowth surfaces - **Antimicrobial coatings:** Silver-doped or antibiotic-loaded surfaces **Joining Technologies:** - **Laser Welding:** Preferred for precision joining - **Electron Beam Welding:** For critical, high-integrity connections - **Diffusion Bonding:** For creating complex porous structures ## Quality Assurance & Regulatory Requirements ### **Implant-Grade Material Certification:** - **EN 10204 3.2 Certificate:** With full chemical, mechanical, and microstructural data - **Heat Traceability:** Complete documentation from melt to finished implant - **Additional Certifications:** - **Corrosion Test Reports:** ASTM F2129, ASTM G61, ASTM G48 - **Fatigue Data:** S-N curves for relevant loading conditions - **Microcleanliness Reports:** Quantitative inclusion analysis ### **Implant-Specific Testing Protocol:** | Test Category | Frequency | Standard | Acceptance Criteria | |---------------|-----------|----------|-------------------| | **Chemical Analysis** | Per heat | ISO 5725 | Within specified ranges | | **Mechanical Properties** | Per heat/lot | ISO 6892-1 | Meet minimum requirements | | **Microstructure** | Per heat | ASTM E112, E45 | Fully austenitic, clean | | **Corrosion Testing** | Per batch | ASTM F2129 | Ebreakdown >700 mV | | **Fatigue Testing** | Representative | ISO 1099 | Meets design life | | **Surface Characterization** | Per batch | ISO 25178 | Meets roughness specifications | ### **Regulatory Pathways:** - **FDA (USA):** Typically 510(k) with substantial equivalence demonstration or PMA for novel applications - **EU MDR (Europe):** Technical documentation per Annex II, clinical evaluation required - **Other Markets:** PMDA (Japan), NMPA (China), TGA (Australia) with country-specific requirements - **Quality Systems:** ISO 13485 compliance mandatory ## Clinical Performance & Comparative Analysis ### **vs. Conventional 316L (ISO 5832-1):** | Parameter | X2CrNiMo18-15-3 | 316L | Clinical Advantage | |-----------|-----------------|------|-------------------| | **Yield Strength** | 500-650 MPa | 250-350 MPa | **~100% higher** - thinner/lighter implants possible | | **Fatigue Limit** | 480-550 MPa | 280-350 MPa | **~70% higher** - longer fatigue life | | **Corrosion Resistance** | PREN 34-40 | PREN 24-26 | **Far superior** - less metal ion release | | **Nickel Release** | Very Low | Moderate | **Reduced sensitivity risk** | | **Implant Longevity** | Potentially extended | Standard | **Fewer revisions** | ### **vs. Titanium Alloys (Ti-6Al-4V):** | Parameter | X2CrNiMo18-15-3 | Ti-6Al-4V | Considerations | |-----------|-----------------|-----------|----------------| | **Elastic Modulus** | 195 GPa | 110 GPa | Stainless steel stiffer, potential stress shielding | | **Density** | 7.98 g/cm³ | 4.43 g/cm³ | Titanium significantly lighter | | **Corrosion Resistance** | Excellent | Outstanding | Both excellent in physiological environments | | **MRI Compatibility** | Excellent | Excellent | Both non-magnetic | | **Cost** | Moderate | Higher | Stainless steel more cost-effective | ### **vs. CoCr Alloys (ISO 5832-12):** | Parameter | X2CrNiMo18-15-3 | CoCrMo | Clinical Implications | |-----------|-----------------|--------|---------------------| | **Wear Resistance** | Good | Excellent | CoCr preferred for bearing surfaces | | **Ductility** | Excellent (40-55%) | Limited (8-15%) | Stainless steel more forgiving during implantation | | **MRI Artifacts** | Minimal | Significant | Stainless steel better for post-op imaging | | **Manufacturing** | Easier | More difficult | Stainless steel offers more design flexibility | | **Biocompatibility** | Excellent | Excellent | Both well-established | ## Limitations & Contraindications ### **Clinical Limitations:** 1. **Not for Articulating Surfaces:** Inferior wear resistance compared to CoCr or ceramics 2. **Relative Contraindications:** - Patients with severe, documented nickel allergy - Applications requiring lowest possible modulus (e.g., hip stems in osteoporosis) - Pediatric growing skeletons (relative) 3. **MRI Considerations:** Although non-magnetic, may cause artifacts in some sequences ### **Manufacturing & Economic Considerations:** 1. **Higher Material Cost:** 2-3× conventional 316L implant steel 2. **Specialized Processing:** Requires implant-specific manufacturing capabilities 3. **Limited Suppliers:** Few producers of implant-grade material 4. **Machining Challenges:** Higher tool wear and slower machining rates ### **Design Limitations:** 1. **Stress Concentrations:** Must be carefully managed in design 2. **Galvanic Couples:** Avoid direct contact with less noble metals in permanent constructs 3. **Surface Finish Requirements:** Critical for performance - adds to manufacturing complexity ## Future Developments & Research Directions ### **Material Innovations:** - **Additive Manufacturing:** Development of optimized powder for 3D-printed patient-specific implants - **Surface Nano-engineering:** Nanostructured surfaces for enhanced osseointegration and antimicrobial properties - **Composites:** Development of stainless steel matrix composites with ceramic reinforcements - **Biodegradable Variants:** Research into controlled degradation profiles ### **Clinical Research Needs:** - **Long-term Retrieval Studies:** >15-year implantation data collection - **Comparative Clinical Trials:** Direct comparison with titanium and CoCr alloys - **Pediatric Applications:** Evaluation in growing skeletons - **Infection Resistance:** Clinical studies of antimicrobial surface modifications ### **Regulatory & Standardization:** - **New ISO Standard:** Specific standard for super-austenitic implant steels - **Harmonized Testing:** Global consensus on test methods and acceptance criteria - **Post-Market Surveillance:** Enhanced tracking of long-term performance ## Economic & Healthcare System Impact ### **Cost-Benefit Analysis:** - **Direct Costs:** Material cost 2-3× 316L, manufacturing cost 1.5-2× - **Potential Savings:** Reduced revision rates, fewer complications - **Healthcare Economics:** Favorable for high-demand implants in active patients - **Value Proposition:** Premium performance at intermediate cost between 316L and titanium ### **Sustainability Considerations:** - **Recyclability:** Fully recyclable through standard stainless steel channels - **Manufacturing Energy:** Lower than titanium alloy production - **Life Cycle Assessment:** Favorable compared to more energy-intensive materials - **Resource Efficiency:** Extends implant life, reduces need for replacements ## Conclusion X2CrNiMo18-15-3 represents a significant advancement in implant metallurgy, offering a unique combination of exceptional corrosion resistance, high mechanical strength, and excellent biocompatibility. As a super-austenitic stainless steel specifically optimized for long-term implantation, it addresses many of the limitations of conventional 316L while avoiding some of the drawbacks of titanium and cobalt-chromium alloys. The alloy's exceptionally high nickel and molybdenum content, combined with controlled nitrogen addition and ultra-low carbon, provides a level of corrosion resistance in physiological environments that approaches that of titanium, while its mechanical properties exceed those of conventional stainless steels. This makes it particularly suitable for demanding applications such as spinal implants, complex trauma fixation, and revision arthroplasty components where strength, corrosion resistance, and long-term stability are critical. While not intended to replace titanium or cobalt-chromium in all applications, X2CrNiMo18-15-3 fills an important niche in the orthopedic implant materials spectrum. It offers surgeons and implant designers an additional option that balances performance, manufacturability, and cost, particularly for applications where the premium properties of titanium are desired but cost constraints are significant. The successful clinical implementation of this advanced alloy requires strict adherence to implant-grade manufacturing protocols, appropriate surface treatments, and careful patient selection. When properly applied, it offers the potential for improved clinical outcomes through enhanced implant performance, reduced metal ion release, and potentially longer service life. As patient demographics shift toward more active and longer-lived individuals, and as healthcare systems seek to optimize outcomes while managing costs, advanced materials like X2CrNiMo18-15-3 will play an increasingly important role in meeting the evolving demands of modern implant surgery. Continued research, clinical experience, and technological development will further define its place in the orthopedic surgeon's armamentarium. -:- For detailed product information, please contact sales. -: X2CrNiMo18153 Stainless Steel for implant surgery Specification Dimensions Size： Diameter 20-1000 mm Length <7423 mm Size:We can customized as required Standard： Per your request or drawing We can customized as required Properties（Theoretical） Chemical Composition -:- For detailed product information, please contact sales. -: X2CrNiMo18153 Stainless Steel for implant surgery Properties -:- For detailed product information, please contact sales. -:

Applications of X2CrNiMo18153 Stainless Steel Tube for implant surgery -:- For detailed product information, please contact sales. -: Chemical Identifiers X2CrNiMo18153 Stainless Steel Tube for implant surgery -:- For detailed product information, please contact sales. -:

Packing of X2CrNiMo18153 Stainless Steel Tube for implant surgery -:- For detailed product information, please contact sales. -: Standard Packing: -:- For detailed product information, please contact sales. -: Typical bulk packaging includes palletized plastic 5 gallon/25 kg. pails, fiber and Steel Tube drums to 1 ton super sacks in full container (FCL) or truck load (T/L) quantities. Research and sample quantities and hygroscopic, oxidizing or other air sensitive materials may be packaged under argon or vacuum. Solutions are packaged in polypropylene, plastic or glass jars up to palletized 3894 gallon liquid totes Special package is available on request. E FORUs’ is carefully handled to minimize damage during storage and transportation and to preserve the quality of our products in their original condition