Medical Titanium (Ti-6Al-4V) Custom Anatomical Curved Bone Plate – Orthopedic Trauma/Corrective Locking Plate
Description
Product Overview
The Custom Anatomical Curved Bone Plate is a precision-engineered orthopedic implant manufactured from medical-grade Ti-6Al-4V titanium alloy. Designed for trauma fixation and corrective orthopedic procedures, this locking plate features an anatomical curvature that closely mimics natural bone contours, ensuring optimal load distribution and promoting faster patient recovery.
Each plate is custom-manufactured to patient-specific anatomical requirements, offering surgeons the flexibility to address complex fracture patterns, deformities, and corrective osteotomies with unparalleled precision. The locking screw mechanism provides angular stability, reducing the risk of screw loosening and enhancing construct rigidity—critical factors in successful fracture healing-1.
As a specialized CNC machining service provider, XINQIDA combines advanced multi-axis machining capabilities with rigorous quality control protocols to deliver implants that meet the most demanding orthopedic standards.
CNC Machining Capabilities & Parameters
| Parameter | Specification |
|---|---|
| Material | Ti-6Al-4V (Grade 5) Titanium Alloy – ASTM F136 / ISO 5832-3 |
| Machining Process | 5-Axis CNC Milling & Turning Center |
| Plate Thickness Range | 1.5mm – 6.0mm (customizable) |
| Plate Width Range | 4mm – 20mm (customizable) |
| Hole Diameter | 2.7mm / 3.5mm / 4.5mm / 5.0mm locking screw holes |
| Hole Count | 2 – 24 holes (customizable per surgical plan) |
| Curvature Radius | Patient-specific anatomical matching |
| Surface Finish | ≤ 0.4μm Ra (mirror-polished / anodized options) |
| Lead Time | 10 – 25 working days (depending on complexity) |
| Quality Standard | ISO 13485:2016 Medical Devices |
| Inspection Equipment | CMM (Coordinate Measuring Machine) ± 0.002mm |
Material Analysis: Ti-6Al-4V (Grade 5)
Ti-6Al-4V is the most widely used titanium alloy in orthopedic implant manufacturing, and for good reason:
Chemical Composition (ASTM F136):
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Titanium: Balance (~90%)
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Aluminum: 5.50 – 6.50%
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Vanadium: 3.50 – 4.50%
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Iron: ≤ 0.25%
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Oxygen: ≤ 0.13%
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Carbon: ≤ 0.08%
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Nitrogen: ≤ 0.05%
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Hydrogen: ≤ 0.012%
Key Properties:
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Biocompatibility: Excellent tissue acceptance with minimal inflammatory response; no known cytotoxic effects
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Corrosion Resistance: Forms a stable, passive oxide layer (TiO₂) that protects against bodily fluids
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Strength-to-Weight Ratio: Ultimate tensile strength ~950 MPa with density of 4.43 g/cm³—significantly lighter than stainless steel while offering comparable strength
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Elastic Modulus: ~110 GPa—closer to cortical bone (~15–20 GPa) than stainless steel (~200 GPa), reducing stress shielding
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Fatigue Resistance: Superior endurance limit (~500–600 MPa) ensuring long-term implant durability under cyclic loading
Application Scenarios
1. Orthopedic Trauma Fixation
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Fracture Types: Comminuted fractures, spiral fractures, and segmental fractures of long bones (femur, tibia, humerus)
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Anatomic Sites: Diaphyseal and metaphyseal regions requiring anatomical contouring
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Clinical Benefit: Locking plate technology provides angular stability ideal for osteoporotic bone or periarticular fractures
2. Corrective Osteotomy
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Indications: Malunion, non-union, and angular deformities of the lower and upper extremities
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Procedures: High tibial osteotomy (HTO), distal femoral osteotomy (DFO), and forearm corrective osteotomies
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Clinical Benefit: Custom anatomical curvature ensures precise realignment without the need for intraoperative bending
3. Periarticular Fracture Management
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Applications: Proximal humerus, distal radius, proximal tibia, and distal femur fractures
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Clinical Benefit: Locking screws create a fixed-angle construct that maintains reduction even in compromised bone quality
4. Pediatric Orthopedics
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Applications: Congenital deformities and growth plate-related conditions requiring smaller, low-profile implants
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Clinical Benefit: Custom sizing reduces soft tissue irritation and implant prominence
Tolerance & Precision Capabilities
| Feature | Tolerance Capability |
|---|---|
| Hole Diameter | ± 0.01mm |
| Hole Position | ± 0.05mm |
| Plate Thickness | ± 0.05mm |
| Plate Width | ± 0.10mm |
| Curvature Profile | ± 0.10mm (along entire contour) |
| Screw Thread Fit | Class 2A / 6H thread tolerance |
| Surface Roughness | ≤ 0.4μm Ra (polished); ≤ 0.8μm Ra (as-machined) |
| Overall Dimension | ± 0.10mm |
| CMM Inspection | 100% critical dimension inspection |
All critical dimensions are verified using Coordinate Measuring Machines (CMM) with measurement uncertainty of ± 0.002mm. Each plate undergoes rigorous dimensional inspection before release.
Manufacturing Challenges & Solutions
| Challenge | Solution |
|---|---|
| Work hardening of Ti-6Al-4V | Use of specialized carbide tooling with optimized cutting parameters (low speeds, high feed rates); flood coolant application to control heat generation |
| Tool wear | Regular tool monitoring and replacement schedules; diamond-like carbon (DLC) coated tools to extend tool life |
| Anatomical curvature complexity | 5-axis simultaneous CNC machining enables complex 3D contours without multiple setups; CAD/CAM programming with patient-specific DICOM data |
| Hole-to-hole positional accuracy | High-precision fixturing and in-process CMM verification; thermal stabilization of machine environment |
| Surface integrity requirements | Multi-stage finishing processes: roughing → semi-finishing → finishing → polishing; electropolishing or anodizing for enhanced corrosion resistance and aesthetics |
| Burr formation | Deburring stations integrated into machining workflow; centrifugal barrel finishing for edge refinement |
| Sterilization compatibility | Passivation treatment to restore oxide layer after machining; packaging in medical-grade sterile barriers |
Frequently Asked Questions
Q1: Can I order a custom bone plate based on patient CT/MRI data?
A: Yes. We accept DICOM data (CT/MRI) for patient-specific plate design. Our engineering team reconstructs the 3D anatomy and designs a plate that precisely matches the bone curvature. Please upload your files through our contact form or reach out to our expert team for guidance-1.
Q2: What is the minimum order quantity (MOQ)?
A: We specialize in custom orthopedic implants with no minimum order quantity. Single-piece orders are welcome for patient-specific applications.
Q3: What surface finishes are available?
A: Options include: mirror-polished (≤ 0.2μm Ra), satin-brushed, bead-blasted, anodized (color options available), and electropolished. The choice depends on the specific clinical application and surgeon preference.
Q4: How do you ensure the quality of each implant?
A: We operate under ISO 13485:2016 quality management system. Each plate undergoes 100% dimensional inspection using CMM, visual inspection under magnification, and surface roughness measurement. Material certificates and inspection reports are provided with every shipment.
Q5: What is the typical lead time for custom plates?
A: Standard lead time is 10–25 working days from design approval, depending on complexity and quantity. Rush services are available for urgent clinical cases.
Q6: Is Ti-6Al-4V MRI-compatible?
A: Yes. Ti-6Al-4V is non-ferromagnetic and considered MRI-conditional (safe under specific scanning conditions). However, always refer to the implant labeling for specific MRI safety information.
Q7: Can you manufacture locking plates with variable-angle locking holes?
A: Yes. We offer both fixed-angle and variable-angle locking hole configurations. Please specify your preference during the design phase.
Q8: What documentation do you provide with each shipment?
A: Each shipment includes: Material test certificate (EN 10204 3.1), dimensional inspection report, surface roughness report, sterility validation (if applicable), and certificate of conformance.
Why Choose XINQIDA for Medical CNC Machining?
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ISO 13485:2016 Certified – Dedicated medical device manufacturing quality system
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State-of-the-Art Equipment – 5-axis CNC machining centers with ± 0.002mm accuracy
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Material Expertise – Extensive experience with Ti-6Al-4V, stainless steel (316L), and Co-Cr alloys
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End-to-End Service – From design consultation to finished, inspected, and packaged implants
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Confidentiality Guaranteed – All patient data and design files are treated as strictly confidential-1
For inquiries, custom design consultations, or to request a quotation, please contact our expert team. All information and uploads are protected securely and treated as confidential.
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