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Linh kiện Cấy ghép Chỉnh hình & Hướng dẫn Phẫu thuật Titan Hạng 5 (Ti-6Al-4V ELI) CNC 5 Trục Tùy chỉnh
Custom medical Grade 5 titanium (Ti-6Al-4V ELI) orthopedic implants, bone plates, and surgical guides. 5-axis CNC micro-machining, ISO 13485, Ra <= 0.2 um, zero burr.
Lợi thế quy trình & giao hàng
- Hỗ trợ dung sai ±0.01mm, bao phủ toàn bộ trung tâm gia công CNC 3/4/5 trục
- Vật liệu bao gồm hợp kim nhôm, thép không gỉ, đồng, hợp kim titan và nhựa kỹ thuật
- Kết hợp với anot hóa, mạ điện, phun sơn, khắc laser và các xử lý bề mặt khác
- Kiểm tra toàn bộ 100% trước khi xuất hàng, cung cấp báo cáo mẫu đầu và dữ liệu CP/CPK kích thước
- Năng lực sản xuất tại nhà máy Đông Quan, 7-15 ngày cho linh kiện tiêu chuẩn, kênh gấp trong vòng 5 ngày
TỔNG QUAN SẢN PHẨM
Tổng quan sản phẩm
Product Overview
Manufactured to exacting international medical standards (ISO 13485, ASTM F136), the Custom 5-Axis CNC Titanium Grade 5 (Ti-6Al-4V ELI) Orthopedic Implant & Surgical Guide Component (Model: MD-TI-01) delivers biocompatible mechanical fixation for human trauma reconstruction, spinal fusion systems, and patient-specific surgical navigation guides.
Utilizing simultaneous 5-axis Swiss-style and micro-milling machining centers operating with diamond/ceramic tooling under pressurized flood coolant, Altus Precision produces organic anatomical curvatures, low-profile tapered contours, and multi-axial combi-threaded locking holes with microscopic burr-free edges. Articulating joint contact surfaces achieve mirror-polished roughness (Ra ≤ 0.2 μm), while bone-interfacing undercuts support controlled micro-rough blasting (Ra 1.6~3.2 μm) for accelerated osseointegration.
Figure 1: 5-Axis CNC Machined Anatomical Titanium Locking Plates with Multi-Angle Screw Receptacles and Color-Coded Anodized Fixation Screws.
Technical Specifications
| Technical Parameter | Design Specification & Standard |
|---|---|
| Medical Material Grade | Medical-Grade Titanium Alloy Ti-6Al-4V ELI (Grade 23 / ASTM F136 / ISO 5832-3) or CP-Ti Grade 2 / Grade 4 |
| Manufacturing Technology | 5-Axis Simultaneous Micro-Milling & Swiss Turn-Mill (Spindle Speeds up to 30,000 RPM) |
| Dimensional Tolerance Class | General: ±0.01mm | Thread Pitch & Depth: ±0.01mm | Freeform Contours: ±0.015 mm (ISO 2768-f) |
| Surface Roughness (Ra) | Articulating Faces: Ra ≤ 0.2 μm (Mirror Lapping) | Osseointegration Zones: Ra 1.6~3.2 μm (Grit Blasted) |
| Biocompatibility & Passivation | Citric Acid Ultrasonic Passivation per ASTM F86 & ASTM A967 | Hydrophobic/Hydrophilic verified |
| Surface Finishing & Color Coding | Type II Anodization (Anti-galling, grey) or Type III Color Anodizing (Magenta/Blue/Gold per screw sizing) |
| Sterilization Sterility Resistance | 100% Autoclave Steam (134 °C, 2.1 bar, ≥ 1000 cycles), Gamma Radiation, and EtO (Ethylene Oxide) compatible |
| Cleanliness & Particle Inspection | Class 10,000 (ISO 7) Cleanroom Ultrasonic Cleaning | Cytotoxicity & Bioburden Tested (ISO 10993) |
Anatomical Geometry & Biomechanical Architecture
- Patient-Matched 3D Freeform Contouring: Milled directly from surgical CT/MRI-derived DICOM and CAD point clouds, ensuring seamless periosteal contact along radius, femur, humerus, and mandibular curves with zero spring-back residual stresses.
- Combi-Hole Locking & Dynamic Compression: Precision dual-function threaded/compression holes accept standard cortex screws for dynamic interfragmentary compression and threaded conical locking screws for angular stability in osteoporotic bone.
- Zero-Burr Micro-Deburring under 50x Magnification: Every screw recess, scallop, and through-hole undergoes cryogenic deburring and automated high-pressure fluid blasting, followed by 100% optical microscopic inspection to prevent microscopic foreign body shedding in vivo.
Anatomical distal bone plate featuring low-profile tapered edges to prevent soft tissue irritation.
Precision Swiss-machined polyaxial pedicle screw with buttress threads and self-tapping flutes.
Full Medical Traceability & Metrology Protocols
- Raw Material Mill Certification: 100% heat-lot traceability with chemical composition and tensile elongation test reports per ASTM F136.
- Optical Profile & Contact CMM Scanning: 3D laser non-contact scanning validates anatomical surface profile deviations within ±0.010 mm.
- Thread Go / No-Go Micro-Gaging: Every internal locking thread is validated with calibrated optical gages.
- ISO 13485 Quality Management: Rigorous Device Master Record (DMR) and Device History Record (DHR) tracking for every production lot.
Frequently Asked Questions (FAQs)
Q1: What medical titanium material certifications does Altus Precision provide?
A: We provide complete raw material mill test certificates (EN 10204 3.1) verifying compliance with ASTM F136 / ISO 5832-3 (Ti-6Al-4V ELI) including chemical composition, interstitial gas analysis (O2 < 0.13%, H2 < 0.012%), and tensile strength verification.
Q2: How do you prevent burrs and micro-metal particulates on titanium implants?
A: We employ dedicated high-speed micro-endmills with specialized titanium coatings, followed by automated multi-stage ultrasonic cavitation deburring and magnetic abrasive finishing. Parts undergo 100% optical inspection under 50x magnification to ensure zero loose particles.
Q3: Can Altus Precision support custom surgical drill guides and patient-specific plates from CT scans?
A: Yes. We work seamlessly with biomedical engineering teams. Customers provide segmented STL/STEP models derived from patient CT data; our 5-axis CAM specialists generate simultaneous 5-axis toolpaths to deliver custom implants and sterilizable surgical guide blocks within 5 to 7 business days.
SẢN PHẨM LIÊN QUAN
Sản phẩm liên quan
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Emailinfo@altusprecision.com
Điện thoại+86 13418313631
WhatsApp+86 13418313631
Địa chỉĐông Quan, Quảng Đông, Trung Quốc