Titanium Bone Plate is a precision-manufactured modular locking compression component designed for Modular locking compression bone plate. Fabricated from Ti-6Al-4V ELI, this component meets the stringent requirements of sterile surgical environments including corrosion resistance to bodily fluids, compatibility with repeated autoclave cycles, and non-magnetic properties for MRI compatibility.

Medical Device / Trauma Fixation / SKU: TI-MD-TRA-TITANI

Titanium Bone Plate

MOQ 1 Unit
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Titanium Bone Plate — Ti-6Al-4V ELI Product Rendering
Also known as: Bone plateCompression plateFixation plate
Technical Parameter Specification
Component SKU TI-MD-TRA-TITANI
Standards & Specifications ASTM B348
Surface Finish Passivation ASTM F86 (20-30% HNO3, 30min @50C)
Trauma Fixation SKU: TI-MD-TRA-TITANI

Titanium Bone Plate

EN 10204 3.1REACHRoHS 3ISO 2768-m
Material Grade: Ti-6Al-4V ELI (ASTM F136)

Modular locking compression bone plate

Technical Specifications Matrix
Technical Parameter Specification Value
International Compliance ASTM B348
Surface Finish & Max Temp Passivation ASTM F86 (20-30% HNO3, 30min @50C)
📜 Quality & Traceability Gate
  • 100% Traceability: Mill Test Certificate (EN 10204 3.1) with heat analysis & mechanical testing.
  • Compliance: REACH, RoHS 3 certified. FAI AS9102 available.
⚙️ CNC & Stress Relief Controls
  • Process: CNC precision machining, vacuum stress relief, thread rolling, surface passivation.
  • Thermal Stress Relief: Post-machining vacuum annealing (540-675°C under Argon) reduces distortion risk >70%.
  • Rolled Threads: Thread rolling (not cutting) increases fatigue limits by 30-50%.
Engineering FAQ
Q: Is Titanium Bone Plate MRI-safe or MRI-conditional?

Ti-6Al-4V ELI is non-ferromagnetic (magnetic susceptibility 1.00005 × 10⁻⁶ cgs) and generates negligible MRI artifact compared to 316L stainless steel. Titanium Bone Plate is classified as MR-Conditional under ASTM F2052/F2213 testing at 1.5T and 3.0T field strengths. Specific absorption rates remain within safe limits for modular locking compression configurations.

Q: What is the typical lead time for Titanium Bone Plate orders?

Standard lead time for Titanium Bone Plate is 15-25 business days depending on quantity and complexity. Rush orders (3-5 working days) are available for prototype evaluation. Sample evaluation (1-5 units) can be expedited to 5-7 business days. Volume pricing is available for production quantities above 100 units.

Q: What material certifications are provided with Titanium Bone Plate?

Each Titanium Bone Plate shipment includes EN 10204 Type 3.1 mill test certificate with chemical analysis, mechanical properties, and heat identification. Dimensional inspection reports and Certificate of Conformance (CoC) are standard. First Article Inspection Reports (FAIR) per AS9102 are available on request for modular locking compression.

Integration: Primary Assembly Integration / Subsystem Mounting Interface
Downstream: Fastener Kit A / Sealing Gasket / Protective Cover
Engineering Report & Product Documentation

§ Why Ti-6Al-4V ELI for modular locking compression

Function

Designed for Medical Device applications, this component fulfills the role of . The use of Ti-6Al-4V ELI (ASTM F136) ensures long-term reliability in this Trauma Fixation configuration.

Specifications

  • SKU: TI-MD-TRA-TITANI
  • Category: Trauma Fixation
  • Industry: Medical Device
  • Material: Ti-6Al-4V ELI (ASTM F136)
  • Process: CNC precision machining, vacuum stress relief, thread rolling, surface passivation
  • Weight: 35-45% lighter than steel equivalents at equivalent section modulus

§ Biocompatibility & Dimensional Inspection

Quality Management

Quality system compliant with ISO 9001:2015. Each Titanium Bone Plate batch includes full material traceability, dimensional inspection results, and a Certificate of Conformity (CoC).

Inspection & NDT

Vision-based optical inspection for surface defects; helium leak testing for sealed interfaces; eddy current surface crack detection on high-stress areas

§ Surgical-Grade Manufacturing Process

Titanium Bone Plate is manufactured using cnc precision machining, vacuum stress relief, thread rolling, surface passivation. Each operation is performed by certified machinists with real-time process monitoring and dimensional verification at critical stages. Heat code traceability is maintained throughout all production steps.

Commercial Logistics & Procurement Framework

Minimum Order (MOQ) 1 Unit
Sample Evaluation 3-5 Business Days
Mass Production Lead 15-25 Business Days (Batch Dependent)
Shipping Basis EXW / FOB Shenzhen

Pricing and lead times for Titanium Bone Plate are batch-dependent. Contact our supply chain team for volume-based tiered pricing.

Regulatory & Quality Assurance Ledger

Verifiable certifications for Titanium Bone Plate

Material Test Certificate (MTC)

EN 10204 3.1

Verified

Environmental Compliance

REACH (EC No 1907/2006)

Verified

Restricted Substances

RoHS 3 Directive (2015/863/EU)

Verified

Quality Management System

ISO 9001:2015

Verified

Dimensional Tolerances

ISO 2768-m

Verified

Standard: ASTM B348

ASTM B348

Available upon Request

Systems Interconnectivity & Topology

Cross-functional integration matrix for Tier-1 supply chains and assembly orchestration.

Upstream System Integration
  • Primary Assembly Integration
  • Subsystem Mounting Interface
Primary Inspected Component

Titanium Bone Plate

Material: Ti-6Al-4V ELI (ASTM F136)

SKU: TI-MD-TRA-TITANI

Industry: Medical Device / System: Medical Implants

Downstream Consumables
  • Fastener Kit A
  • Sealing Gasket
  • Protective Cover

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