Medical Grade Titanium CNC Machining Services
ISO 13485:2016 certified manufacturing delivering biocompatible, high-precision titanium micro-components and orthopedic implants. Specializing in Swiss CNC turning for bone screws and dental abutments with zero-contamination ultrasonic cleaning lifecycle.
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CNC Swiss Machining — Grade 23 Ti-6Al-4V ELI Medical Bone Screws & Dental Abutments
High-precision CNC Swiss turning of Grade 23 Titanium (Ti-6Al-4V ELI — Extra Low Interstitials) for medical bone screws, dental abutments, and micro-implants. Surface roughness controlled to Ra ≤ 0.4 µm to promote optimum osseointegration.
Grade 23 Ti-6Al-4V ELI Swiss Turning
CNC Swiss Lathe · Extra Low Interstitials · Bone ScrewsGrade 23 Ti-6Al-4V ELI (ASTM F136) is the gold standard for surgical implants — with reduced oxygen, carbon, and iron content for improved fracture toughness and biocompatibility. Our CNC Swiss lathes produce bone screws, dental abutments, and micro-implants in diameters from 1.5–12 mm with L:D ratios exceeding 20:1, all in single-setup operations.
Technical Implementation- Precision-ground form tools produce Ra ≤ 0.4 µm on thread roots and flanks — promotes osteoblast cell attachment
- Controlled thread root radius eliminates micro-notches — reduces stress concentration under cyclic loading
- 100% optical thread inspection — compliant with ASTM F543 bone screw standards
Osseointegration Surface Optimization
Surface Roughness Ra ≤ 0.4 µm · Implant Grade FinishSurface topography of titanium implants directly influences osseointegration success. Our Swiss turning process achieves Ra ≤ 0.4 µm on thread flanks and bone-contact surfaces — produced through precision-ground form tools and micro-finishing passes that eliminate micro-cracks and stress risers on Grade 23 ELI titanium components.
Technical Implementation- Precision-ground form tools produce Ra ≤ 0.4 µm on thread roots and flanks — promotes osteoblast cell attachment
- Controlled thread root radius eliminates micro-notches — reduces stress concentration under cyclic loading
- 100% optical thread inspection — compliant with ASTM F543 bone screw standards
5-Axis CNC Milling — Orthopedic Implants, Trauma Plates & Surgical Instrumentation
Simultaneous 5-axis milling of Grade 5 and Grade 23 titanium for orthopedic joint implants, trauma fixation plates, and precision surgical instruments. Complex anatomical surfaces machined in single-setup operations with tolerances held to ±0.005 mm.
Orthopedic Implant Milling
5-Axis CNC · Grade 23 ELI · ±0.005mmOur 5-axis machining centers produce complex anatomical implant geometries — femoral knee components, acetabular cups, spinal interbody cages, and custom patient-specific implants — in single-setup operations. Simultaneous contouring eliminates the need for EDM or secondary finishing, reducing lead time by up to 40%.
Technical Implementation- Multi-axis simultaneous contouring of compound anatomical surfaces — eliminates secondary EDM or benching operations
- Single-setup machining of complete implant geometries — eliminates positional errors from re-fixturing multiple operations
- Achieves ±0.005 mm tolerance on critical mating surfaces — ensures proper fit with mating joint components
Surgical Instrument Manufacturing
Grade 5 & Grade 23 · Burr-Free · SterilizableSurgical instruments demand consistent precision, durability, and sterilizability. Our 5-axis milling centers produce complex instrument geometries from Grade 5 and Grade 23 titanium, with sharp burr-free edges and smooth surfaces that withstand repeated sterilization cycles.
Technical Implementation- Burr-free edge finishing — critical for soft-tissue safety in surgical instrument applications
- Ergonomic handle contouring and textured grip surfaces machined in the same setup
- Material compatibility: Grade 5 (Ti-6Al-4V) and Grade 23 (Ti-6Al-4V ELI) for both reusable and single-use instruments
Zero-Contamination Post-Processing — Ultrasonic Cleaning Lifecycle for Medical Implants
Every medical-grade component undergoes an institutional ultrasonic cleaning lifecycle using deionized water to completely eliminate cutting fluids, machining residues, and particulate contamination — ensuring full compliance with cytotoxicity and bio-burden thresholds for surgical implant applications.
Ultrasonic Cleaning Lifecycle
A multi-stage ultrasonic cleaning process using deionized water and medical-grade detergents — removing all cutting fluid residues, chip debris, and particulate contamination from every surface, including internal threaded bores and blind holes.
- Multi-tank ultrasonic cascade with deionized water rinsing at each stage — eliminates cross-contamination
- Medical-grade enzymatic detergent — breaks down protein-based residues from machining coolants
- Final DI water rinse with resistivity ≥ 18 MΩ·cm — leaves zero ionic residue on implant surfaces
Bio-Burden & Cytotoxicity Control
Cleaning validation per ISO 19227 and ISO 10993 standards. Lot-specific bio-burden testing verifies that microbial contamination remains below implantable-device thresholds. Cytotoxicity testing per ISO 10993-5 confirms the absence of leachable residues.
- Bio-burden testing per ISO 11737-1 — verifies microbial count below implantable-device thresholds
- Cytotoxicity testing per ISO 10993-5 — confirms absence of leachable residues from cutting fluids or cleaning agents
- Process validation per ISO 19227 — documented cleaning efficacy for each implant product family
Clean Packaging & Delivery
After cleaning, medical components are packaged in controlled environments to maintain purity through transit. Individual sterile barrier packaging options available for direct-to-surgery delivery, eliminating secondary cleaning at the hospital.
- Individual Tyvek pouch packaging for clean-to-surgery delivery
- Lot-specific cleaning batch records for full process traceability
- Controlled-environment storage prior to dispatch — maintains certified cleanliness
ISO 13485:2016 Compliance — EN 10204 3.1 MTR & ELI Grade Material Traceability
Full compliance with ISO 13485:2016 Clause 7.5.9 for traceability, delivered with EN 10204 3.1 Mill Test Reports. Every Grade 23 Ti-6Al-4V ELI lot is chemically verified for low oxygen and carbon interstitials — the critical parameters that define ELI-grade biocompatibility.
EN 10204 3.1 Mill Test Reports
Every medical-grade raw material lot — Grade 23 Ti-6Al-4V ELI and Grade 5 — is certified with EN 10204 Type 3.1 inspection documentation. Chemical composition is verified for ELI-specific limits: oxygen ≤ 0.13%, carbon ≤ 0.08%, iron ≤ 0.25%, ensuring the extra-low interstitial properties critical for implant safety.
- Chemical composition verified per ASTM E2371 — O₂ ≤ 0.13%, C ≤ 0.08%, Fe ≤ 0.25% for ELI grade
- Mechanical properties: UTS ≥ 860 MPa, Yield ≥ 795 MPa, Elongation ≥ 10% per ASTM F136
- Digital MTR archive with 10-year retention — full lot traceability for regulatory audits
ISO 13485:2016 Quality System
Our quality management system is certified to ISO 13485:2016 — the international standard for medical device manufacturing. Clause 7.5.9 traceability requirements are integrated into every production step, from raw material receiving to finished goods dispatch.
- Risk management per ISO 14971 — systematic identification and mitigation of manufacturing risks
- Document-controlled processes: DHR, DMR, device master record for every product family
- 10-year record archival — fully compliant with FDA 21 CFR Part 820 and EU MDR requirements
CMM Dimensional Validation
All medical components receive CMM dimensional inspection per engineering drawing callouts. ZEISS CMM platforms with ±1.9 µm accuracy validate thread forms, surface profiles, hole positions, and mating features against ASME Y14.5 GD&T standards — ensuring every bone screw and implant meets design intent.
- ZEISS CMM — ±1.9 µm volumetric accuracy, ISO 17025 traceable calibration
- GD&T interpretation per ASME Y14.5 — flatness, position, profile, runout verification
- Full dimensional report delivered with each lot — auditable by regulatory bodies
Ready for ISO 13485 Certified
Medical Titanium CNC Machining?
Submit your implant or instrument design files for a complimentary Design for Manufacturability (DFM) review. Our engineering team will evaluate your bone screw, orthopedic implant, or surgical instrument requirements and respond with a competitive quote within 24 hours.
Engineering response within 24 hours · CAD models accepted in STEP, IGES, STL formats
One Metal. One Focus. Infinite Precision.
Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, ISO 13485 & ISO 9001 certified with 500+ clients across Aerospace, Medical & Motorsport industries, we deliver end-to-end precision titanium CNC machining with full material traceability from source to component.
Boze Titanium Manufacturing Center is operated by Baoji Boze Metal Products Co., Ltd.
Certifications verified by NADCAP and compliant with ASTM International titanium standards (B265, B348, B381, F136, F2924) and ISO 13485 medical-device QMS.