Product Parameters
| Item | Specification |
|---|---|
| Material | Titanium (Ti-6Al-4V, Ti-6Al-4V ELI), Stainless Steel (316L) |
| Forging | Closed-Die, Precision Forging |
| Application | Bone plates, screws, clips, anchors |
| Quality | ISO 13485, FDA 21 CFR 820, CE Mark |
| Surface | Passivated, electropolished |
| MOQ | 10 pcs |
description
Surgical implant forgings serve the wide range of surgical devices that support, stabilize, or replace body structures - bone plates, screws, clips, and anchors that remain in the body for months or years. The mechanical properties, corrosion resistance, and surface finish all determine how well the implant performs inside the human body. Ti-6Al-4V and Ti-6Al-4V ELI titanium alloys are the most common materials for load-bearing surgical implants - the combination of good strength, excellent corrosion resistance, and biocompatibility makes titanium the standard for most permanent implants. 316L stainless steel is used for temporary implants like screws and wires that are removed after healing.
Why Surface Treatment Is Non-Negotiable
The surface of an implant is not cosmetic - it is the interface between the material and the body. A rough surface promotes bacterial adhesion and tissue irritation. An electropolished surface is smooth enough that bacteria cannot hide and tissue heals cleanly against it. Passivation restores the chromium oxide layer that gives stainless its corrosion resistance in the body environment.
FAQ
Q1: MOQ?
A1: 10 pieces for surgical implant forgings.
Q2: Materials?
A2: Ti-6Al-4V ELI for permanent implants. 316L stainless for temporary implants.
Q3: Quality systems?
A3: ISO 13485, FDA 21 CFR 820, CE Mark available.
Q4: Surface treatment?
A4: Passivated and electropolished for biocompatibility and corrosion resistance.
Q5: Heat treatment?
A5: Solution annealed for machining. Aging for final properties.
Q6: Custom configurations?
A6: Yes. Custom implant geometries for specific surgical procedures.
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
- CMM Inspection - Coordinate measuring for complex geometries and tight tolerances
- Surface Roughness Measurement - Ra, Rz, and Rt charting with every inspection report
- 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:
- Billet Heating - Precision heating to forging temperature with temperature monitoring
- Forging - Closed-die, open-die, or ring rolling to near-net shape
- Trimming / Piercing - Flash removal and bore operations
- Heat Treatment - Through-hardening, case-hardening, or age-hardening as required
- Finishing Machining - CNC machining, grinding, or super-finishing to final dimensions
- Surface Treatment - Anodizing, plating, or shot peening as specified
- Inspection & Testing - Dimensional check, hardness testing, surface inspection
- Cleaning & Packaging - Degreasing, rust prevention, and protective packaging
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