SpiTrex 3D
+1 760-349-1551
1815 Aston Ave #106
Carlsbad, CA 92008
Additive Manufacturing, Elevated by Design
At SpiTrex 3D, we deliver a full ecosystem of design, production and regulatory services driven by orthopedic advancement. Our strength lies in the convergence of Design for Additive Manufacturing, engineering expertise and a fully validated manufacturing environment. From complex titanium implants to high-precision surgical tools, we partner with customers to take products from concept to commercialization with speed, accuracy and confidence.
With industry-leading Renishaw Quad Laser Printers and an FDA Master File supporting our 3D printing and post-processing methods, we’re strategically positioned to accelerate regulatory approval while maintaining world-class quality and repeatability.
Co-Designing for Additive Manufacturing
We specialize in designing complex implant geometries and surgical tools that unlock the full potential of additive manufacturing. Through enhancements such as optimized lattice creations and integrated surgical functions, our co-design process minimizes material use, boosts biomechanical performance and simplifies production from the start.
Engineering Services
Our engineering team provides complete design support, including prototyping, project management, Design History Files, Risk Analyses and Design Transfer, making certain every product is development and submission ready.
Additive Manufacturing
We operate a full-scale additive manufacturing platform using best-in-class Renishaw quad-laser systems, delivering consistent, high-resolution outputs for prototypes, V&V test parts, and through full, high-volume commercial production or patient specific devices.
Validations & Regulatory Support
We support every stage of the device lifecycle, including process validations while assisting with or fully drafting regulatory submissions. Our FDA Master Files streamline new 510(k) submissions and/or provide justifications for transferring existing product lines to our highly controlled ecosystem.
Thermal Treatments, HIP & VSR
We have validated traditional Hot Isostatic Pressing (HIP) and in-house Vacuum Stress Relieving (VSR) cycles for residual stress relief, microstructure optimization, mechanical property enhancements and homogenization.
Subtractive Manufacturing
Our upfront DfAM feedback can help minimize secondary machining while ultimately reducing lead times and costs.However, when your designs require complex subtractive features or assemblies with machined parts, our broader SpiTrex locations are dedicated to high-precision machining, with workflows fully integrated with 3D.
Sterile Packaging
Our integrated process allows us to ship clean and internally passivated 3D-printed product directly to your preferred packaging and sterilization vendor or we can package and steam sterilize in our controlled environment.
Quality Systems
Our ISO 13485-registered and FDA-compliant Quality Management System (QMS) makes certain all products consistently meet customer specifications, regulatory requirements, and safety standards. Our 3D printing process control monitors, fully documented within our FDA Master Files, create complex statistical datasets for consistently high-quality products without overburdening lead times and costs. Our QMS focus on continual improvements ensures we remain leaders within the rapidly advancing field of additive manufacturing.