Medical Device

🧲 MRI-Compatible Cranial Fixation & Stereotactic Frames

Ring-shaped frame with 4-point pin fixation, adjustable arc/quadrant for probe targeting, vernier scales for coordinate positioning

3 Processes

What is MRI-Compatible Cranial Fixation & Stereotactic Frames?

🧲 MRI-Compatible Cranial Fixation & Stereotactic Frames represents a complete system of precision titanium components engineered for Medical Device applications. Ring-shaped frame with 4-point pin fixation, adjustable arc/quadrant for probe targeting, vernier scales for coordinate positioning The system integrates 0 distinct component types manufactured through 3 specialized processes.

Engineering & Design Principles

Material: Grade 1 (CP-Ti) is non-magnetic and MRI-compatible, producing zero image artifact. Higher strength than plastics but without the magnetic susceptibility of steel or even Grade 5.

Form: Bar and plate stock for ring fabrication. Small diameter bar for fixation pins. All material must be certified MRI-safe (magnetic susceptibility <10^-5).

Standards & Material Specifications

Standards: ASTM B348 Grade 1 CP-Ti, annealed, MRI compatibility certified, 100% coordinate inspection + passivated

🧱

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:

Vacuum arc remelting (VAR) of ELI-grade ingotGun-drilling of intramedullary nails + cannulated screwsLPBF 3D printing of porous fusion cagesThread rolling of pedicle screws (never cut threads)Passivation + Class 10,000 cleanroom ultrasonic wash

Toll Processing Services:

100% dimensional inspection (CMM)Mechanical testing per ASTM F543 (screw torque)MRI artifact testing (3T phantom)Surface roughness measurement (Ra 1.0-3.0um for osseointegration)Sterilization validation (gamma/EtO)

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

1
CNC machining of ring and frame components

5-axis CNC milling centers provide simultaneous multi-axis interpolation for complex titanium components. The ability to tilt the tool relative to the

2
Coordinate measurement of fiducial markers

Fiber laser marking on titanium produces high-contrast, permanent identification marks by controlled surface oxidation or micro-engraving. UDI codes,

3
Precision drilling of pin guides

Laser drilling of titanium uses pulsed laser energy to create precise holes through percussion or trepanning methods. Hole diameters range from 0.05 m

Components in This System

Frequently Asked Questions

What titanium grades are used in MRI-Compatible Cranial Fixation & Stereotactic Frames systems?
MRI-Compatible Cranial Fixation & Stereotactic Frames components are manufactured from titanium grades selected for their specific functional requirements, including Grade 2, Grade 5 (Ti-6Al-4V), and Grade 23 ELI as applicable.
What manufacturing processes are used for MRI-Compatible Cranial Fixation & Stereotactic Frames?
MRI-Compatible Cranial Fixation & Stereotactic Frames components are manufactured using processes selected for each component's specific geometry, tolerance, and volume requirements.
What quality standards apply to MRI-Compatible Cranial Fixation & Stereotactic Frames components?
All MRI-Compatible Cranial Fixation & Stereotactic Frames components are manufactured under ISO 9001:2015 and AS9100D certified quality management systems.
What industries use MRI-Compatible Cranial Fixation & Stereotactic Frames?
MRI-Compatible Cranial Fixation & Stereotactic Frames systems serve the Medical Device industry, with components engineered to meet sector-specific regulatory and performance standards.
Can you provide DFM feedback for MRI-Compatible Cranial Fixation & Stereotactic Frames designs?
Yes. Our engineering team provides free Design for Manufacturability (DFM) analysis for MRI-Compatible Cranial Fixation & Stereotactic Frames projects. Upload your CAD file (STEP, DXF, or DWG format) and our team will review your design within 24 hours.

Engineering Trends

  • Process: CNC machining of ring and frame components
  • Process: Precision drilling of pin guides
  • Process: Coordinate measurement of fiducial markers

Related Manufacturing Capabilities

These specialized processes support MRI-Compatible Cranial Fixation & Stereotactic Frames component manufacturing.

About Boze Titanium Manufacturing Center

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.

AS9100D ISO 13485 ISO 9001 500+ Clients 15+ Years OEM/ODM