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Titanium Orthopedic Self Tapping Cortical Bone Screws

Titanium Orthopedic Self Tapping Cortical Bone Screws
Details:
Services:Specialized 5-axis CNC milling and precision thread grinding for complex-geometry orthopedic fasteners.

Capacity:High-volume production infrastructure capable of delivering over 50,000 medical-grade screws monthly.

Finishes:Medical-grade surface options including Type II/III anodization, electropolishing, and nitric acid passivation.

Specifications:Guaranteed compliance with ASTM F136 and ISO 5832-3 standards with tolerances held to ±0.008mm.

Quality Control:Stringent ISO 13485:2016 protocol involving CMM verification and 50x microscopic burr inspection.

Lead Time:Accelerated manufacturing cycles of 7 days for prototypes and 15–20 days for mass production.

MOQ:Engineering-friendly minimum order quantities starting from 10 units for R&D and clinical trials.

Drawings:Full compatibility with industrial standard formats including STEP, IGS, DWG, and high-resolution PDFs.

Value-Add:Complimentary DFM (Design for Manufacturing) optimization to refine tool paths and reduce unit costs.
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Description
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Titanium Orthopedic Self Tapping Cortical Bone Screws Ti-6Al-4V ELI

Medical-grade precision for superior osteosynthesis and intraoperative efficiency.

Core Engineering Features:

Standard Compliance: Fully compatible with international ISO/ANSI orthopedic plate systems.

Surgical Efficiency: Precision-milled self-tapping flutes for aggressive and high-torque bone engagement.

Cleanroom Prep: Degreased and ultrasonic-cleaned in ISO Class 7 (10,000) cleanroom environments.

Metallurgy: Ultra-low interstitial Ti-6Al-4V ELI (Grade 23) biocompatible alloy.

Mechanical Precision: Concentricity and pitch accuracy strictly maintained at ±0.008mm.

Size Coding: Multi-color electrolytic anodization for rapid intraoperative diameter identification.

Structural Integrity: Monoblock 5-axis milling ensures zero stress-fractures compared to forged screws.

Drive Interface: Slip-free Star or Hex drive slots prevent intraoperative tool stripping and metal debris.

Implant Certification: Fatigue-tested and certified for long-term load-bearing cortical fixation.

Ti-6Al-4V ELI Orthopedic Cortical Bone Screws

 

Precision 5-Axis CNC Milling Capabilities for Medical Implants

Dazao specializes in the precision engineering of Titanium Orthopedic Self Tapping Cortical Bone Screws designed for diaphysis fixation in trauma surgeries. Unlike standard lathed components, our CNC medical parts are milled from solid Ti-6Al-4V ELI bars (ASTM F136). This integrated 5-axis machining process preserves material grain structure, ensuring high fatigue strength for cortical bone fragment compression. The self-tapping tip design eliminates the need for intraoperative tapping, reducing surgical time and minimizing thermal bone necrosis.

Zero Micro-fracture Self-tapping Cortical Screws

 

Technical Specifications and Material Standards for Cortical Screws

Parameters

Specification Details

Material Grade

Ti-6Al-4V ELI (Grade 23), ASTM F136, ISO 5832-3

Diameter Range

2.0mm, 2.4mm, 2.7mm, 3.5mm, 4.5mm (Standard & Custom)

Length Range

6.0mm – 50.0mm (0.5mm or 1.0mm increments)

Machining Tolerance

±0.008mm (Critical dimensions)

Surface Roughness

Ra 0.4 - Ra 0.8 (Mirror polishing available)

Thread Type

Cortical fine-pitch thread with self-tapping flutes

Drive Interface

Hexagonal, Star (Torx), or Cruciform

Cleaning Standard

Ultrasonic degreasing + Class 10,000 Cleanroom packing

Custom CNC Orthopedic Cortical Bone Screws

 

ISO 13485 Quality Control and Traceability Standards

Every batch of titanium bone screws undergoes a rigorous inspection protocol to meet Class III medical implant standards:

 

· Material Traceability: 100% heat lot traceability with original mill certificates.

· Dimensional Inspection: Key parameters verified via CMM and OGP optical measurement systems.

· Torque Testing: Verification of torsional strength and drive-slot engagement integrity.

· Surface Analysis: Microscopic inspection for burrs at 50x magnification.

· Documentation: FAI (First Article Inspection) and COA (Certificate of Analysis) provided per shipment.

3.5mm Standard Self-tapping Cortical Bone Screws

 

Proprietary CNC Engineering for Enhanced Implant Fatigue Strength

Curved Chip-Breaking Micro-Grooves: Utilizing 5-axis simultaneous milling, we create curved drainage flutes. Unlike traditional straight flutes, this geometry directs bone chips outward more efficiently, preventing radial pressure that causes micro-fractures in dense cortical bone.

 

Root Arc Passivation: All thread roots undergo secondary CNC path passivation to eliminate sharp internal angles. This redistribution of stress increases the screw's cyclic fatigue resistance by 38%, preventing post-operative breakage during weight-bearing cycles.

 

Nano-scale Mirror Deburring: We implement a proprietary CNC polishing cycle that removes microscopic metallic burrs in thread crevices. This reduces metal ion leaching by 92% compared to standard sandblasted screws, significantly lowering the risk of soft tissue inflammation.

Low Stress Self-tapping Orthopedic Cortical Screws

Clinical Indications and Surgical Application Scenarios

Our cortical screws are engineered for maximum stability in dense bone structures and are fully compatible with standard orthopedic bone plates for hybrid fixation:

Lower Limb Fixation

Lower Limb Fixation

Cortical bone fragment compression in tibial and fibular shafts.

Orthopedic Plating

Orthopedic Plating

Complementary screws for LC-DCP and locking plate systems.

Osteosynthesis

Osteosynthesis

Primary fixation for corrective osteotomies.

Veterinary Orthopedics

Veterinary Orthopedics

High-strength implants for small and large animal fracture repair.

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Frequently Asked Questions

 

 

FDA Certified Titanium Cortical Bone Implant Screws

01.Why is self-tapping functionality critical for cortical bone screws?

The self-tapping tip contains cutting edges that create a thread path during insertion. This eliminates the pre-tapping step, reducing surgery time and lowering the risk of thermal necrosis caused by friction in dense cortical bone.

02.What are the advantages of Ti-6Al-4V ELI over standard Grade 5 titanium?

ELI (Extra Low Interstitials) Grade 23 titanium contains lower levels of oxygen and iron. This results in significantly higher ductility and fracture toughness, which is essential for medical implants subjected to stress.

03.Can Dazao provide color-anodized screws for surgical sets?

Yes. We provide Type II and Type III anodizing. This allows for color-coding by diameter (e.g., 2.7mm is blue, 3.5mm is gold), facilitating faster instrument selection during trauma surgery.

04.How does Dazao prevent screw head stripping during high-torque insertion?

We maintain a ±0.008mm tolerance on the drive socket. This tight fit with the screwdriver interface ensures maximum torque transfer and prevents the driver from camming out in dense bone.

05.Are these screws compatible with third-party locking plates?

Our screws are machined to ISO and ASTM orthopedic standards. We can customize thread pitches and head angles to ensure 100% compatibility with any existing locking or compression plate system.

06.What documentation is provided for medical device regulatory compliance?

Every shipment includes a Certificate of Conformity (CoC), Material Test Reports (MTR) with heat numbers, and a full dimensional inspection report for total regulatory traceability.

Request a Technical Quote

Upload your 2D/3D CAD files (STEP, IGS, or PDF) for a technical review.

Our engineers provide a comprehensive quote and machining feasibility report within 24 hours to accelerate your surgical implant production.

 

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