Product Parameters
| Item | Specification |
|---|---|
| Material | Titanium (Ti-6Al-4V ELI), CoCr (CoCrMo) |
| Type | Locking, non-locking, variable angle |
| Diameter | 2.0 mm – 7.5 mm |
| Application | Orthopedic trauma, spinal fixation, reconstructive surgery |
| Surface | Passivated, electropolished |
| Quality | ISO 13485, FDA 21 CFR 820 |
| MOQ | 10 pcs |
description
Orthopedic fixation screws work with plates and rods to stabilize bone fragments - the locking plate system uses screws that lock into the plate to create a fixed-angle construct, while non-locking screws allow the plate to float on the bone for more biological fracture healing. Variable angle screws allow the surgeon to adjust the screw angle within a limited range. Ti-6Al-4V ELI titanium provides the combination of strength, biocompatibility, and corrosion resistance required for permanent implantation. Cobalt chrome (CoCrMo) is used for screws that must withstand high wear or fatigue loading - the wear resistance of CoCr is superior to titanium in joint replacement applications. The thread geometry is optimized for the specific bone type and loading conditions - cortical bone screws have fine threads for hard bone, cancellous bone screws have coarse threads for softer bone. The screw head is designed to engage the plate and provide the locking or non-locking function specified.
Locking vs. Non-Locking - What the Surgeon Decides
Locking screws: the head locks into the plate, creating a fixed-angle construct. The joint does not depend on the screw purchase in the bone for its stability - this matters when the bone quality is poor. Non-locking screws: the plate sits on the bone and the screw compresses the plate to the bone. The construct depends on the screw purchase in the bone. Used when the bone is healthy and some flexibility in the construct helps fracture healing. The choice is surgical, not mechanical.
FAQ
Q1: MOQ?
A1: 10 pieces for orthopedic fixation screw production.
Q2: Materials?
A2: Ti-6Al-4V ELI titanium. CoCrMo for high-wear applications.
Q3: Screw systems?
A3: Locking, non-locking, variable angle - selection depends on surgical approach.
Q4: Surface treatment?
A4: Electropolished - smooth, cleanable surfaces for long-term implantation.
Q5: Quality systems?
A5: ISO 13485 and FDA 21 CFR 820 compliant.
Q6: Custom configurations?
A6: Yes. Custom thread geometries and sizes for specific fixation systems.
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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