X2CrNiMoN18133 Stainless Steel Sheet,Plate,for implant surgery

X2CrNiMoN18133 Stainless Steel Sheet/Plate for implant surgery Product Information -:- For detailed product information, please contact sales. -: X2CrNiMoN18133 Stainless Steel Sheet/Plate for implant surgery Synonyms -:- For detailed product information, please contact sales. -:

X2CrNiMoN18133 Stainless Steel for implant surgery Product Information -:- For detailed product information, please contact sales. -: # X2CrNiMoN18-13-3 High-Nitrogen Austenitic Stainless Steel for Implant Surgery ## Overview X2CrNiMoN18-13-3 is a premium nitrogen-enhanced, low-carbon austenitic stainless steel specifically engineered for demanding implant surgery applications. This alloy represents a significant advancement over conventional implant-grade stainless steels by combining ultra-low carbon content, optimized molybdenum addition, and controlled nitrogen enrichment to deliver exceptional corrosion resistance, enhanced mechanical strength, and superior biocompatibility. Designed to meet the stringent requirements of long-term orthopedic and trauma implants, it offers a compelling balance of properties that bridge the gap between traditional 316L stainless steel and more expensive cobalt-chromium or titanium alloys. ## International Standards & Designations | Standard System | Designation | Notes | |----------------|-------------|-------| | **European (EN)** | 1.4456 | Not exact match; closest designated grade | | **ISO** | X2CrNiMoN18-13-3 | Material designation | | **ISO 5832-9** | - | Wrought high nitrogen stainless steel for surgical implants | | **ASTM** | F1586 (similar) | Standard for nitrogen strengthened 22Mn-13Cr-1Mo alloy | | **UNS** | S31653 (approximate for 316LN) | Similar nitrogen-enhanced grade | | **Common References** | High-N 316L, 316LN+ | Industry terminology | ## Chemical Composition (Typical, % by weight) | Element | Minimum (%) | Maximum (%) | Optimal Range (%) | Functional Significance | |---------|-------------|-------------|-------------------|-------------------------| | **Carbon (C)** | - | 0.030 | 0.015-0.025 | Minimizes sensitization risk | | **Chromium (Cr)** | 17.00 | 19.00 | 17.5-18.5 | Corrosion resistance, passive film formation | | **Nickel (Ni)** | 12.00 | 14.00 | 12.5-13.5 | Austenite stabilization, ductility | | **Molybdenum (Mo)** | 2.50 | 3.50 | 2.8-3.2 | Pitting/crevice corrosion resistance | | **Nitrogen (N)** | 0.12 | 0.22 | 0.15-0.20 | Solid solution strengthening, enhances corrosion resistance | | **Manganese (Mn)** | - | 2.00 | 1.5-2.0 | Austenite stabilizer, nitrogen solubility enhancer | | **Silicon (Si)** | - | 0.75 | 0.20-0.50 | Deoxidizer | | **Phosphorus (P)** | - | 0.025 | ≤0.020 | Impurity control (minimize) | | **Sulfur (S)** | - | 0.010 | ≤0.005 | Impurity control (minimize) | | **Iron (Fe)** | Balance | Balance | Balance | Base element | **Critical Composition Features:** - **Ultra-low carbon** (<0.03%) prevents chromium carbide precipitation during welding/implant fabrication - **Nitrogen addition** (0.12-0.22%) provides solid solution strengthening without compromising ductility - **Elevated molybdenum** (2.5-3.5%) ensures exceptional pitting/crevice corrosion resistance in physiological environments - **Balanced Cr/Ni ratio** ensures stable austenitic microstructure under implant loading conditions - **Stringent impurity control** (P, S) minimizes inclusion content for improved fatigue resistance ## Physical Properties (Solution Annealed Condition) | Property | Value | Test Condition | Clinical Relevance | |----------|-------|----------------|-------------------| | **Density** | 7.95 g/cm³ | 20°C | Lighter than CoCr alloys | | **Melting Point** | 1380-1420°C | - | Manufacturing process compatibility | | **Thermal Conductivity** | 14.8 W/m·K | 20°C | Heat dissipation during machining | | **Specific Heat Capacity** | 500 J/kg·K | 20°C | - | | **Electrical Resistivity** | 0.82 μΩ·m | 20°C | Electrosurgical compatibility | | **Modulus of Elasticity** | 200 GPa | 20°C | Closer to bone than CoCr alloys | | **Magnetic Permeability** | ≤1.02 | Annealed | MRI compatibility (non-ferromagnetic) | | **Coefficient of Thermal Expansion** | 15.9 × 10⁻⁶/K | 20-100°C | Thermal compatibility with bone | | **Thermal Diffusivity** | 3.7 mm²/s | 20°C | - | ## Mechanical Properties (Implant Quality) ### **Solution Annealed Condition (ISO 5832-9 Requirements):** | Property | Minimum Value | Typical Range | Test Standard | |----------|---------------|---------------|---------------| | **Tensile Strength (Rm)** | 750 MPa | 800-950 MPa | ISO 6892-1 | | **Yield Strength (Rp0.2)** | 430 MPa | 480-600 MPa | ISO 6892-1 | | **Elongation at Break (A)** | 30% | 35-50% | ISO 6892-1 | | **Reduction of Area (Z)** | 45% | 50-65% | ISO 6892-1 | | **Hardness (HV)** | 250 HV | 260-320 HV | ISO 6507-1 | | **Fatigue Strength** | 400 MPa | 420-480 MPa (10⁷ cycles) | ISO 1099 | | **Impact Toughness** | 80 J | 100-150 J (Charpy V, 20°C) | ISO 148-1 | ### **Cold Worked Properties (for specific implant applications):** | Cold Work Level | Tensile Strength | Yield Strength | Hardness | Fatigue Strength | |-----------------|------------------|----------------|----------|------------------| | **20% Cold Work** | 950-1100 MPa | 800-950 MPa | 300-350 HV | 450-520 MPa | | **30% Cold Work** | 1050-1200 MPa | 900-1050 MPa | 320-380 HV | 480-550 MPa | | **40% Cold Work** | 1150-1300 MPa | 1000-1150 MPa | 350-420 HV | 500-580 MPa | ### **Comparative Mechanical Advantages:** - **30-50% higher yield strength** than conventional 316L implant steel - **Superior fatigue resistance** compared to standard implant stainless steels - **Excellent toughness retention** despite high strength levels - **Minimal property degradation** after long-term implantation ## Heat Treatment & Microstructural Control ### **Solution Annealing (Mandatory for Implants):** - **Temperature:** 1050-1150°C (1920-2100°F) - **Soak Time:** 30-60 minutes (minimum), dependent on section size - **Cooling:** Rapid water quenching (preferred) or forced air cooling - **Purpose:** Dissolve all carbides/nitrides, homogenize structure, optimize corrosion resistance ### **Microstructural Requirements:** - **Fully austenitic structure** with <0.5% delta ferrite - **Grain size:** ASTM 5-7 (medium-fine) for optimal strength-toughness balance - **Inclusion control:** Maximum inclusion rating per ASTM E45 (typically A, B, C, D ≤1.0 thin series) - **No continuous grain boundary precipitation** allowed ### **Special Processing Requirements:** - **Vacuum or electroslag remelting** for implant-quality material - **Controlled hot working** to ensure uniform microstructure - **Stress relieving:** 400-500°C (optional, for complex shapes) - **No sensitization treatments** permitted ## Corrosion Resistance in Physiological Environments ### **Quantitative Corrosion Metrics:** - **Pitting Resistance Equivalent Number (PREN):** PREN = %Cr + 3.3×%Mo + 16×%N - **Typical PREN:** 32-38 (significantly higher than 316L's ~25) - **Clinical significance:** Excellent resistance to pitting in chloride-containing body fluids ### **In-Vivo Corrosion Performance:** | Environment | Performance | Test Method | Acceptance Criteria | |-------------|-------------|-------------|-------------------| | **Physiological Saline (0.9% NaCl)** | Excellent | ASTM F2129 | No pitting up to 800 mV vs. SCE | | **Ringer's Solution** | Excellent | ISO 16429 | Corrosion rate <0.1 μm/year | | **Simulated Body Fluid** | Excellent | ISO 16429 | No localized corrosion | | **Crevice Conditions** | Very Good | ASTM G48 | CCT >22°C | ### **Special Corrosion Considerations for Implants:** 1. **Fretting Corrosion:** Superior resistance at modular implant junctions 2. **Galvanic Corrosion:** Compatible with Ti-6Al-4V and CoCr alloys in mixed-metal constructs 3. **Stress Corrosion Cracking:** Excellent resistance in physiological chloride environments 4. **Intergranular Attack:** Negligible risk due to ultra-low carbon content ### **Metal Ion Release (Critical for Long-term Implants):** - **Nickel release:** <0.1 μg/cm²/week (significantly lower than conventional stainless) - **Chromium release:** <0.05 μg/cm²/week - **Overall biocompatibility:** Reduced metal sensitivity reactions compared to standard grades ## Biocompatibility & Biological Response ### **ISO 10993 Compliance:** | Test Category | Standard | Typical Result | Requirement | |---------------|----------|----------------|-------------| | **Cytotoxicity** | ISO 10993-5 | Non-cytotoxic (Grade 0) | Pass | | **Sensitization** | ISO 10993-10 | Non-sensitizing | Pass | | **Irritation** | ISO 10993-10 | Non-irritating | Pass | | **Systemic Toxicity** | ISO 10993-11 | Non-toxic | Pass | | **Genotoxicity** | ISO 10993-3 | Non-genotoxic | Pass | | **Implantation (90 days)** | ISO 10993-6 | Minimal tissue response | Pass | ### **Osteocompatibility:** - **Direct bone apposition** observed in animal studies - **No fibrous encapsulation** with proper surface finish - **Surface modifications** (hydroxyapatite coating, porous structures) compatible ### **Nickel Sensitivity Considerations:** - **Reduced nickel release** due to stable passive film - **Suitable for most patients** with nickel sensitivity (case-by-case evaluation) - **Alternative materials** required for severe nickel allergy cases ## Product Applications in Implant Surgery ### **Orthopedic Trauma Implants:** 1. **Fracture Fixation Devices:** - Dynamic compression plates (DCP) - Limited contact dynamic compression plates (LC-DCP) - Locking compression plates (LCP) - Intramedullary nails and rods - Cannulated screws and fixation pins 2. **Spinal Implants:** - Pedicle screw systems - Spinal fixation rods - Interbody fusion devices - Cervical plating systems ### **Reconstructive Surgery:** 1. **Joint Arthroplasty:** - Cementless stem trials and guides - Temporary fixation components - Revision surgery instruments - *Note: Not typically for permanent bearing surfaces* 2. **Cranio-Maxillofacial:** - Reconstruction plates - Mesh for cranial defects - Fixation systems for facial fractures ### **Specialized Applications:** - **External fixation systems** (higher strength components) - **Orthopedic cables and wires** - **Suture anchors** for soft tissue reattachment - **Dental implant components** (non-oral cavity exposure) ### **Advantages for Specific Implant Types:** | Implant Type | Key Advantage | Clinical Benefit | |--------------|---------------|------------------| | **Spinal Rods** | High fatigue strength | Reduced risk of implant failure | | **Fracture Plates** | Excellent corrosion resistance | Minimizes inflammatory response | | **Intramedullary Nails** | Good toughness | Withstands insertion forces | | **Pedicle Screws** | High yield strength | Resists bending under load | ## Manufacturing & Processing for Implants ### **Implant-Specific Fabrication Requirements:** **Machinability (Solution Annealed):** - **Rating:** Fair to Difficult (30-40% of free-machining steel) - **Challenges:** Work hardening, abrasive carbides/nitrides - **Recommended Tools:** Premium carbide with specialized coatings (TiAlN, AlCrN) - **Coolants:** Biocompatible, residue-free coolants required **Forming & Forging:** - **Hot Working:** 1150-900°C range with rapid cooling below 850°C - **Cold Forming:** Limited to simple bends; intermediate annealing often required - **Precision Forging:** Suitable for near-net-shape implant components **Surface Treatments (Critical for Implants):** 1. **Electropolishing:** Standard finish (Ra 0.2-0.4 μm) for corrosion resistance 2. **Passivation:** Nitric acid per ASTM A967 (implant-grade validation required) 3. **Special Finishes:** - **Grit-blasted:** For cement fixation surfaces - **Porous coatings:** For biological fixation (Ti or HA coatings applied) - **Polished:** For articulating surfaces in temporary components **Joining Technologies:** - **Laser Welding:** Preferred for implant assemblies - **Electron Beam Welding:** For critical, high-integrity joints - **Conventional Welding:** Generally avoided for permanent implants ## Quality Assurance & Regulatory Requirements ### **Material Certification (Implant Grade):** - **EN 10204 3.2 Certificate:** Full traceability with additional test reports - **Chemical Analysis:** Per heat and product form - **Mechanical Properties:** Full testing including fatigue data - **Microcleanliness Report:** Inclusion ratings per ASTM E45 - **Corrosion Test Reports:** ASTM F2129, ASTM G61 ### **Implant-Specific Testing:** | Test | Standard | Frequency | Acceptance Criteria | |------|----------|-----------|-------------------| | **Microstructure** | ASTM E112 | Each heat | Fully austenitic, no precipitates | | **Inclusion Rating** | ASTM E45 | Each heat | A, B, C, D ≤1.0 thin series | | **Intergranular Corrosion** | ASTM A262 E | Each heat | No indication of attack | | **Pitting Corrosion** | ASTM F2129 | Each batch | Breakdown potential >600 mV | | **Fatigue Testing** | ISO 1099 | Representative | Meets design life requirements | | **Surface Analysis** | ISO 18535 | Each batch | Meets specified roughness & cleanliness | ### **Regulatory Compliance Pathways:** - **FDA (USA):** 510(k) or PMA with complete material characterization - **EU MDR:** Technical documentation per Annex II of 2017/745 - **ISO 13485:** Quality management system requirements - **Country-Specific:** PMDA (Japan), NMPA (China), etc. ## Clinical Performance & Comparative Advantages ### **vs. Conventional 316L Implant Steel:** | Parameter | X2CrNiMoN18-13-3 | 316L (ISO 5832-1) | Advantage | |-----------|-------------------|-------------------|-----------| | **Yield Strength** | 480-600 MPa | 250-350 MPa | **40-70% higher** | | **Fatigue Limit** | 420-480 MPa | 280-350 MPa | **30-40% higher** | | **Corrosion Resistance** | PREN 32-38 | PREN 24-26 | **Superior** | | **Nickel Release** | Lower | Higher | **Better biocompatibility** | | **Implant Longevity** | Extended | Standard | **Potential for longer service** | ### **vs. Titanium Alloys:** - **Advantages:** Higher stiffness, better wear resistance, lower cost - **Disadvantages:** Higher density, potential metal sensitivity concerns - **Clinical selection:** Based on specific application requirements ### **vs. CoCr Alloys:** - **Advantages:** Better ductility, easier manufacturing, MRI compatibility - **Disadvantages:** Lower wear resistance for bearing surfaces - **Application focus:** Non-articulating, load-sharing components ## Limitations & Contraindications ### **Clinical Limitations:** 1. **Not for Bearing Surfaces:** Inferior wear resistance compared to CoCr or ceramic 2. **MRI Compatibility:** Generally safe but may cause artifacts 3. **Nickel Sensitivity:** Contraindicated for patients with severe nickel allergy 4. **Load Limitations:** Not for highest load applications (e.g., hip stems in heavy patients) ### **Manufacturing Limitations:** 1. **Specialized Processing:** Requires implant-grade manufacturing facilities 2. **Cost:** Higher than standard 316L, lower than titanium/CoCr 3. **Availability:** Limited to specialized producers ### **Design Considerations:** - **Stress concentrations:** Must be minimized in design - **Surface finish:** Critical for corrosion resistance and biocompatibility - **Galvanic couples:** Avoid with less noble metals in permanent constructs ## Future Developments & Research Directions ### **Material Innovations:** - **Additive Manufacturing:** Development of implant-specific powder formulations - **Surface Functionalization:** Bioactive surface treatments for enhanced osseointegration - **Nanostructured Variants:** For improved mechanical and biological properties ### **Clinical Research Needs:** - **Long-term retrieval studies** (>10 years implantation) - **Comparative clinical trials** vs. titanium and CoCr alloys - **Pediatric applications** evaluation - **Infection resistance** surface modifications ### **Regulatory Evolution:** - **Standardization** of high-nitrogen stainless steels in implant applications - **Harmonization** of global regulatory requirements - **Post-market surveillance** protocols for new implant materials ## Economic & Healthcare System Considerations ### **Cost-Benefit Analysis:** - **Material Cost:** 1.5-2.0× conventional 316L implant steel - **Manufacturing Cost:** Similar to other implant stainless steels - **Clinical Benefits:** Potential for reduced revision rates, longer implant life - **Healthcare Economics:** Favorable for high-demand implant applications ### **Sustainability Aspects:** - **Recyclability:** Fully recyclable through standard channels - **Manufacturing Energy:** Lower than titanium alloy production - **Life Cycle Assessment:** Favorable compared to more energy-intensive materials ## Conclusion X2CrNiMoN18-13-3 represents a significant advancement in implant-grade stainless steel technology, offering orthopedic and trauma surgeons a material that combines the manufacturing familiarity of stainless steel with enhanced mechanical properties and superior corrosion resistance. Its nitrogen-enhanced composition provides a unique balance of strength, toughness, and biocompatibility that makes it particularly suitable for demanding implant applications where conventional 316L may be marginal. While not intended to replace titanium or cobalt-chromium alloys in all applications, this alloy fills an important niche in the implant materials spectrum. It offers a cost-effective solution for applications requiring higher strength than standard stainless steel but where the premium cost of titanium or the manufacturing challenges of cobalt-chromium are not justified. The successful clinical implementation of X2CrNiMoN18-13-3 requires strict adherence to implant-grade manufacturing protocols, appropriate surface treatments, and careful patient selection. When properly processed and applied, it offers the potential for improved clinical outcomes through enhanced implant performance and longevity. As the field of implant surgery continues to evolve toward more active and longer-lived patient populations, advanced materials like X2CrNiMoN18-13-3 will play an increasingly important role in meeting the demands of modern orthopedic practice, providing surgeons with additional options for optimizing patient care while managing healthcare system resources effectively. -:- For detailed product information, please contact sales. -: X2CrNiMoN18133 Stainless Steel for implant surgery Specification Dimensions Size： Diameter 20-1000 mm Length <7422 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. -: X2CrNiMoN18133 Stainless Steel for implant surgery Properties -:- For detailed product information, please contact sales. -:

Applications of X2CrNiMoN18133 Stainless Steel Sheet,Plate for implant surgery -:- For detailed product information, please contact sales. -: Chemical Identifiers X2CrNiMoN18133 Stainless Steel Sheet,Plate for implant surgery -:- For detailed product information, please contact sales. -:

Packing of X2CrNiMoN18133 Stainless Steel Sheet/Plate 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 Sheet/Plate 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 3893 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