Product Parameters
| Item | Specification |
|---|---|
| Material | Titanium (Ti-6Al-4V, Ti-6Al-4V ELI) |
| Application | Maxillofacial, dental, orthopedic reconstruction |
| Type | Bone screws, tissue anchors, fixation wires |
| Surface | Passivated, electropolished, anodized (colored) |
| Quality | ISO 13485, FDA 21 CFR 820, CE Mark |
| MOQ | 10 pcs |
description
Surgical implant screws serve maxillofacial surgery, dental implants, and orthopedic reconstruction - the screws anchor bone plates, attach tissue anchors, and provide the fixation that reconstructive surgery requires. These are permanent implants that must function reliably in the body for decades. Ti-6Al-4V is the standard material for surgical implant screws - the alloy provides the strength, corrosion resistance, and biocompatibility that implantation requires. Ti-6Al-4V ELI (Extra Low Interstitial) has better ductility and fracture toughness for fatigue-critical applications. Surface treatment is critical for long-term corrosion resistance and biocompatibility: passivation restores the chromium oxide layer that provides corrosion resistance; electropolishing creates the smooth, contamination-resistant surface that prevents bacterial adhesion and tissue irritation.
Why Color Anodizing for Surgical Screws
Surgical teams work under time pressure and cannot read part numbers during surgery. Colored anodizing - blue, gold, green - identifies screw sizes and types at a glance in a bloody surgical field. The color is not decorative; it is a visual sorting system that reduces the risk of selecting the wrong screw size during a procedure. The anodizing does not affect the biocompatibility of the titanium and adds essentially no cost to the finished screw.
FAQ
Q1: MOQ?
A1: 10 pieces for surgical implant screw production.
Q2: Materials?
A2: Ti-6Al-4V and Ti-6Al-4V ELI titanium.
Q3: Surface treatment?
A3: Passivated and electropolished standard. Colored anodizing for identification.
Q4: Quality systems?
A4: ISO 13485, FDA 21 CFR 820, CE Mark available.
Q5: Applications?
A5: Maxillofacial, dental, orthopedic reconstruction - permanent surgical implants.
Q6: Custom configurations?
A6: Yes. Custom thread geometries, head styles, and lengths.
Quality is non-negotiable in precision manufacturing. Every component undergoes rigorous inspection at each stage of production.
- ISO 13485 - Full FDA compliance support; quality management system for medical device components
- ISO 11607 / FDA 21 CFR 820 - Packaging and sterilization validation for implantable and surgical devices
- ASTM F136 / F67 - Material specification compliance for implant-grade titanium and stainless
- First Article Inspection (FAI) - Full dimensional and functional report for every medical component
- Passivation / Electropolishing - ASTM A967 procedures for corrosion resistance
- Material Traceability - Heat number tracking from raw material to finished part
- MIL-A-8625 - Military-specification anodizing for aluminum components
- Coating Thickness Testing - Coating weight and thickness verification per MIL spec
- Salt Spray Testing - 1000-hour ASTM B117 corrosion resistance verification available
From raw material to finished product, every step is controlled and documented:
- Material Preparation - CNC turning/milling to near-net shape
- Heat Treatment - Through-hardening or case-hardening for strength-critical parts
- Surface Preparation - Degreasing, acid cleaning, and surface activation
- Electroplating - Controlled bath process with thickness monitoring
- Sealing / Baking - Chrome sealing, anodize sealing, or hydrogen embrittlement relief baking
- Inspection - Coating thickness measurement, adhesion testing, and visual check
- Packaging - Protective interleaving, VCI packaging, and anti-tarnish wrapping
Hot Tags: surgical implant screws, China surgical implant screws manufacturers