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.
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 (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 ImplementationSurface 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 ImplementationSimultaneous 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.
Our 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 ImplementationSurgical 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 ImplementationEvery 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.
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.
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.
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.
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.
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.
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.
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.
Everything a Medical engineering buyer needs to evaluate us in one place: materials, components, manufacturing capability, and quality compliance.
Send us your drawing and material specification. Our engineers respond with a DFM review, tolerance assessment, and quote within 48 hours.
Role-specific answers and resources for engineers and buyers in this industry.
We operate under ISO 13485 and ISO 9001; implantable-grade parts are made from Ti-6Al-4V ELI (Grade 23) with full material certification and traceability.
Ti-6Al-4V ELI (Grade 23) is the most common implantable grade, offering high strength, biocompatibility and a lower interstitial content for improved toughness.
Yes—precision grinding and controlled finishing achieve Ra down to 0.4 µm and mirror finishes where specifications require.
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.