Product Parameters
| Item | Specification |
|---|---|
| Material | Titanium (Ti-6Al-4V ELI), Cobalt Chrome (CoCrMo) |
| Forging | Closed-Die, Precision Forging |
| Application | Hip stems, knee femoral components, spinal implants |
| Quality | ISO 13485, FDA 21 CFR 820 |
| Surface | Machined, polished, textured |
| MOQ | 10 pcs |
description
Orthopedic implant forgings are the high-performance forgings that replace failed joints and support broken bones - hip stems, knee femoral components, and spinal implants that carry the body's weight and movement for years inside the body. The material, forging process, and heat treatment all determine how long the implant lasts. Ti-6Al-4V ELI is the standard material for joint replacement stems and plates - the extra low interstitial version has better ductility and fracture toughness for the fatigue loading that implants endure. Cobalt chrome (CoCrMo) is used for knee femoral components and other articulating surfaces where wear resistance matters more than strength-to-weight ratio. Forgings provide the grain flow and mechanical properties that machined or cast implants cannot match - the forging process produces components with directional properties aligned with the loading direction.
Why Forgings Beat Castings for Implants
A casting has grain that is random and coarse - a forged implant has grain that follows the contour of the bone-replacing shape. The fatigue strength of a forging is significantly higher than the same alloy as a casting. For an implant that must last 20 years under cyclic loading, that difference matters.
FAQ
Q1: MOQ?
A1: 10 pieces for implant forgings.
Q2: Materials?
A2: Ti-6Al-4V ELI titanium. CoCrMo cobalt chrome for articulating surfaces.
Q3: Quality systems?
A3: ISO 13485 and FDA 21 CFR 820 compliant.
Q4: Surface finish?
A4: Machined, polished, or textured depending on implant type and application.
Q5: Heat treatment?
A5: Solution treated for machining. Aging for final properties.
Q6: Custom configurations?
A6: Yes. Custom implant geometries for specific surgical requirements.
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:
- Pattern Making - Wooden or metal pattern fabrication for sand/centrifugal/investment casting
- Molding - Sand casting, shell mold, centrifugal, or lost-wax investment casting setup
- Melting & Pouring - Controlled furnace melting with chemistry and temperature monitoring
- Solidification & Shakeout - Controlled cooling with riser/removal and core shakeout
- Heat Treatment - Annealing, normalizing, or solution treatment per specification
- Machining - CNC machining, drilling, and tapping to final dimensions
- Surface Treatment - Grinding, welding, or coating as required
- Inspection & Testing - Dimensional, visual, hydrostatic, or NDT inspection
- Cleaning & Packaging - Sand removal, degreasing, rust prevention, and packaging
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