SpiTrex 3D
+1 760-349-1551
1815 Aston Ave #106
Carlsbad, CA 92008
Strategy That Starts With Planning
At SpiTrex 3D, our process is a strategic framework built around collaboration, speed, and first-rate quality. We have refined a workflow that integrates engineering, additive manufacturing, and regulatory strategy into a single, focused path to production.
Every phase is designed to reduce friction, anticipate challenges, and support your product’s success from the earliest design discussions through final validated output.
A Smarter Way to Design
Our process begins with design. By applying Design for Additive Manufacturing (DfAM) from day one, we help create devices that are not only functional, but also optimized for printability, performance, and minimal post-processing. Complex geometries, surgical functionality, and internal features are planned with intention rather than treated as workarounds.
This approach allows us to eliminate unnecessary machining, simplify the path to final form, and accelerate time to market without compromising clinical objectives.
Engineering That Moves With You
Our engineering support is embedded throughout the entire project lifecycle. With decades of experience in orthopedic product development, we offer:
- Prototyping and iterative development
- Project management
- Complete design history documentation
- Risk analysis and regulatory-aligned development
You remain connected to your design at every stage, while we proactively address potential roadblocks.
From Print to Production
Using Renishaw quad-laser additive systems, production at SpiTrex 3D is fully commercial-grade and highly controlled.
Post-processing is executed through a validated sequence of steps, including Vacuum Stress Relief (VSR), Hot Isostatic Pressing (HIP), dimensional inspection, and surface finishing. Our FDA Master File supports efficient regulatory submissions, helping reduce delays and streamline the path to clearance.
A Process Built for Regulatory Reality
Orthopedic innovation goes beyond the part, extending through compliance, sterilization, and validation. That’s why we provide complete support for:
- Cleanliness and packaging validation
- Biocompatibility documentation
- Regulatory strategy and submission support
We align with ISO 13485 standards and operate as an FDA-registered facility, delivering quality you can rely on and proof you can submit with confidence.