Medical Device

🏥 Medical Implants

Small precision part, complex curved surfaces (articular), hex/cross drive, self-tapping thread

8 Components 3 Materials 3 Processes 8 Standards

What is Medical Implants?

🏥 Medical Implants represents a complete system of precision titanium components engineered for Medical Device applications. Small precision part, complex curved surfaces (articular), hex/cross drive, self-tapping thread The system integrates 8 distinct component types manufactured through 3 specialized processes.

Key manufacturing processes for this system include CNC swiss turning for orthopedic joints geometry, Cryogenic deburring with Class 6g gauge, Ultrasonic clean Class 10k with Class 6g gauge, Sterile packaging with Class 6g gauge, CNC swiss turning for trauma fixation geometry, each selected and qualified to meet component-specific requirements.

Engineering & Design Principles

Material: Grade 23 ELI (ASTM F136) is the standard for surgical implants. Extra-low interstitials (O<=0.13%) improve fracture toughness. Do not substitute industrial TC4.

Form: Bar is the standard form for bone screws/plates. Single-setup Swiss turning, good surface quality, batch consistency.

Standards & Material Specifications

Standards: ASTM F136, Annealed, 100% dimensional inspection + surface contamination test, sterile packaging

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Engineering Solution Blueprint

Medical Implants

Medical Device

1 Part Feature Analysis

Small precision part, complex curved surfaces (articular), hex/cross drive, self-tapping thread

  • ⚠️ Biocompatibility
  • ⚠️ Fatigue fracture
  • ⚠️ Osseointegration
  • ⚠️ Sterile processing
  • ⚠️ Stress shielding

2 Material Selection Rationale

Grade 23 Ti-6Al-4V ELI — Ultra-low interstitial, implant grade

Grade 23 ELI (ASTM F136) is the standard for surgical implants. Extra-low interstitials (O<=0.13%) improve fracture toughness. Do not substitute industrial TC4.

3 Form Selection Rationale

Round Bar / Rod — for turning, fasteners

Bar is the standard form for bone screws/plates. Single-setup Swiss turning, good surface quality, batch consistency.

4 Manufacturing Process & Services

Core Processes:

Automatic Swiss turningThread rolling / formingElectrochemical polishing

Toll Processing Services:

Passivation (ASTM F86)Cleaning & packaging (Class 8 cleanroom)Laser marking (UDI code)

Process Pitfalls:

  • ⚠️ Self-tapping threads require no burrs; use thread rolling instead of cutting
  • ⚠️ Implant surface must be free of iron contamination; use dedicated Ti-alloy tooling

5 Procurement Specifications

ASTM F136, Annealed, 100% dimensional inspection + surface contamination test, sterile packaging

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Manufacturing Process Flow

1
Automatic Swiss turning

Swiss-type automatic lathes use a sliding headstock and fixed guide bushing to machine slender titanium components. The guide bushing supports the bar

2
Electrochemical polishing

Titanium anodizing (AMS 2488) grows a controlled oxide layer through electrochemical conversion in an electrolyte bath. Type II produces interference

3
Thread rolling / forming

Thread rolling cold-forms threads by displacing material between two reciprocating or rotary dies, rather than cutting it away. Compressive residual s

Components in This System

Component Material
Titanium Acetabular Cup Ti-6Al-4V ELI (ASTM F136)
Titanium Bone Plate Ti-6Al-4V ELI (ASTM F136)
Titanium Bone Screw Ti-6Al-4V ELI (ASTM F136)
Titanium Craniofacial Mesh Grade 2 CP-Ti
Titanium Femoral Condyle Ti-6Al-7Nb (ASTM F1295)
Titanium Hip Stem Ti-6Al-4V ELI (ASTM F136)

Frequently Asked Questions

What titanium grades are used in Medical Implants systems?
Medical Implants components are manufactured from Ti-6Al-4V ELI (ASTM F136), Grade 2 CP-Ti, Ti-6Al-7Nb (ASTM F1295). The specific grade is selected based on mechanical property requirements, corrosion resistance needs, and Medical Device industry regulations.
What manufacturing processes are used for Medical Implants?
The Medical Implants system components are produced using CNC swiss turning for orthopedic joints geometry, Cryogenic deburring with Class 6g gauge, Ultrasonic clean Class 10k with Class 6g gauge, Sterile packaging with Class 6g gauge, CNC swiss turning for trauma fixation geometry, Cryogenic deburring with 0.5mm corner radius. Each process is selected and qualified to meet the specific dimensional, metallurgical, and surface requirements of each component within the system.
What quality standards apply to Medical Implants components?
Medical Implants components are manufactured to ISO 14971 (porous biomimetic applied), ASTM F136 (modular locking applied), ASTM F136 (corticalcancellous locking applied), ASTM F136 (reconstruction mesh applied), ASTM F136 (total knee applied) and other applicable specifications. Full material traceability, dimensional inspection reports, and certificates of conformance are provided with each shipment.
What industries use Medical Implants?
Medical Implants systems are deployed in Medical Device applications. Each industry has specific regulatory and performance requirements that drive material selection and process qualification.
Can you provide DFM feedback for Medical Implants designs?
Yes. Our engineering team provides free Design for Manufacturability (DFM) analysis for Medical Implants projects. Upload your CAD file (STEP, DXF, or DWG format) and our team will review your design within 24 hours.

Engineering Trends

  • ▸ Process: Automatic Swiss turning
  • ▸ Process: Thread rolling / forming
  • ▸ Process: Electrochemical polishing

Related Manufacturing Capabilities

These specialized processes support Medical Implants component manufacturing.

Automatic Swiss turning Electrochemical polishing Thread rolling / forming
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 CNC Ti is the dedicated titanium manufacturing center of Baoji Boze Metal Products Co., Ltd.

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