Medical Device
🧱 Trauma & Spine Fixation Hardware
Intramedullary nails with proximal/distal locking holes, pedicle screw tulip heads for rod connection, interbody fusion cages with lattice architecture, craniofacial reconstruction mesh, cannulated bone screws with guidewire channels, polyaxial connection rods
What is Trauma & Spine Fixation Hardware?
🧱 Trauma & Spine Fixation Hardware represents a complete system of precision titanium components engineered for Medical Device applications. Intramedullary nails with proximal/distal locking holes, pedicle screw tulip heads for rod connection, interbody fusion cages with lattice architecture, craniofacial reconstruction mesh, cannulated bone screws with guidewire channels, polyaxial connection rods The system integrates 3 distinct component types manufactured through 3 specialized processes.
Key manufacturing processes for this system include CNC swiss turning for spine fixation geometry, Cryogenic deburring with 0.5mm corner radius, Ultrasonic clean Class 10k with 0.5mm corner radius, Sterile packaging with 0.5mm corner radius, Cryogenic deburring with Class 6g gauge, each selected and qualified to meet component-specific requirements.
Engineering & Design Principles
Material: Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3) is mandatory for all permanent spinal and trauma implants. Oxygen <0.13%, iron <0.25% for maximum fracture toughness. Grade 9 (Ti-3Al-2.5V) for spinal rods requi
Form: VAR-melted bar stock for nails and screws via gun-drilling + swiss turning. LPBF 3D printing for interbody cages with porous lattice. Precision sheet stamping + chemical etching for craniofacial mesh.
Standards & Material Specifications
Standards: ASTM F136 / ISO 5832-3 Ti-6Al-4V ELI, 100% dimensional + mechanical tested, cleanroom packed (ISO 7), MTC traceable to VAR ingot
Engineering Solution Blueprint
Trauma & Spine Fixation Hardware
Medical Device
1 Part Feature Analysis
Intramedullary nails with proximal/distal locking holes, pedicle screw tulip heads for rod connection, interbody fusion cages with lattice architecture, craniofacial reconstruction mesh, cannulated bone screws with guidewire channels, polyaxial connection rods
- ⚠️ Stress shielding from implant-to-bone stiffness mismatch causing osteopenia
- ⚠️ Screw pullout in osteoporotic bone with low bone mineral density
- ⚠️ MRI artifact generation from ferrous alloys obscuring post-op imaging
- ⚠️ Fatigue fracture of nails under early patient weight-bearing protocol
- ⚠️ Screw back-out from cyclic spinal loading causing loss of correction
2 Material Selection Rationale
Grade 23 Ti-6Al-4V ELI — Ultra-low interstitial, implant grade
Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3) is mandatory for all permanent spinal and trauma implants. Oxygen <0.13%, iron <0.25% for maximum fracture toughness. Grade 9 (Ti-3Al-2.5V) for spinal rods requiring intraoperative bendability with spring-back. Ti-6Al-7Nb (ASTM F1295) for vanadium-free pediatric implants.
3 Form Selection Rationale
Round Bar / Rod — for turning, fasteners
VAR-melted bar stock for nails and screws via gun-drilling + swiss turning. LPBF 3D printing for interbody cages with porous lattice. Precision sheet stamping + chemical etching for craniofacial mesh. Centerless ground bar for spinal rods.
4 Manufacturing Process & Services
Core Processes:
Toll Processing Services:
Process Pitfalls:
- ⚠️ Cannulated screw guidewire channel concentricity must be <0.1mm TIR to prevent wire binding during insertion
- ⚠️ Pedicle screw tulip head must accept rods up to +-15 degrees angulation for multi-level constructs
- ⚠️ Interbody cage porosity must be 60-80% with pore size 300-600um for optimal bone ingrowth — verified by micro-CT
5 Procurement Specifications
ASTM F136 / ISO 5832-3 Ti-6Al-4V ELI, 100% dimensional + mechanical tested, cleanroom packed (ISO 7), MTC traceable to VAR ingot
Manufacturing Process Flow
Laser drilling of titanium uses pulsed laser energy to create precise holes through percussion or trepanning methods. Hole diameters range from 0.05 m
Selective Laser Melting (SLM/DMLS) builds titanium components layer-by-layer from metal powder using a fiber laser. Internal lattice structures, confo
Professional manufacturing process for semiconductor titanium components. Vacuum arc remelting (VAR) of ELI-grade ingot is performed by certified tech
Components in This System
| Component | Material |
|---|---|
| Titanium Spinal Fixation Rod | Grade 9 Ti-3Al-2.5V |
| Titanium Spinal Interbody Cage | Ti-6Al-4V ELI (ASTM F136) |
| Titanium Spinal Pedicle Screw | Ti-6Al-4V ELI (ASTM F136) |
Frequently Asked Questions
What titanium grades are used in Trauma & Spine Fixation Hardware systems?
What manufacturing processes are used for Trauma & Spine Fixation Hardware?
What quality standards apply to Trauma & Spine Fixation Hardware components?
What industries use Trauma & Spine Fixation Hardware?
Can you provide DFM feedback for Trauma & Spine Fixation Hardware designs?
Engineering Trends
- ▸ Process: Vacuum arc remelting (VAR) of ELI-grade ingot
- ▸ Process: Gun-drilling of intramedullary nails + cannulated screws
- ▸ Process: LPBF 3D printing of porous fusion cages
Related Manufacturing Capabilities
These specialized processes support Trauma & Spine Fixation Hardware component manufacturing.
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.