Product Parameters
| Item | Specification |
|---|---|
| Material | Titanium (Ti-6Al-4V ELI), Stainless Steel (316L) |
| Type | Cortex, cancellous, Herbert, cannulated |
| Diameter | 1.5 mm – 8.0 mm |
| Application | Orthopedic surgery, fracture fixation, spinal fusion |
| Surface | Passivated, electropolished |
| Quality | ISO 13485, FDA 21 CFR 820 |
| MOQ | 10 pcs |
description
Orthopedic bone screws fix fractures and stabilize bone reconstruction - the screw must bite into bone without stripping, hold securely through loading, and remain in the body for years without corrosion or failure. The materials and designs are developed specifically for the demanding environment of human implantation. Ti-6Al-4V ELI is the standard for orthopedic screws - the extra low interstitial version provides better ductility and fracture toughness for the fatigue loading that bone screws see. 316L stainless is used where the strength of titanium is not needed and the lower cost of stainless is preferred. Cortex screws have aggressive thread profiles for biting into hard cortical bone - the standard orthopedic screw for most fracture fixation applications. Cancellous screws have larger, deep threads for gripping softer cancellous bone. Herbert screws are headless for insertion below the bone surface. Cannulated screws have a central hole for guide wire insertion during surgery.
Why Orthopedic Screws Strip If You Are Not Careful
Bone screws are designed to compress bone fragments - not to cut threads into the bone like a machine tap cuts threads into metal. The bone thread is created by the screw itself as it drives in. If the pilot hole is too large, the screw has nothing to bite. If you over-torque the screw, the bone thread compresses and fails. The correct technique: drill the pilot hole to the right size for the screw diameter, tap if specified (some self-tapping designs do not need tapping), and stop driving when the screw seats. Overtightening costs you the grip.
FAQ
Q1: MOQ?
A1: 10 pieces for orthopedic screw production.
Q2: Materials?
A2: Ti-6Al-4V ELI titanium. 316L stainless steel.
Q3: Screw types?
A3: Cortex, cancellous, Herbert, cannulated - selection depends on surgical application.
Q4: Surface treatment?
A4: Passivated and electropolished - smooth, cleanable surfaces for implantation.
Q5: Quality systems?
A5: ISO 13485 and FDA 21 CFR 820 compliant.
Q6: Documentation?
A6: Material certificates, heat treatment records, inspection reports for every lot.
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
From raw material to finished product, every step is controlled and documented:
- Wire / Bar Preparation - Cold heading or CNC blanking to near-net shape
- Thread Rolling / Cutting - Thread rolling for rolled threads or die cutting for cut threads
- Heat Treatment - Case-hardening or through-hardening for strength requirement
- Surface Treatment - Plating, coating, or passivation as specified
- Final Inspection - Dimensional check, torque testing, and surface inspection
- Packaging - Bulk bag, polybag, or plastic tub with labeling and traceability
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