Pedicle screws have been a cornerstone of spinal fixation for decades, offering the stability and precision necessary for complex spinal reconstruction and fusion procedures. But early designs were limited by the capabilities of traditional manufacturing. Surgeons often faced challenges related to bone integration, stress distribution, and mechanical performance that became more pronounced as patient populations grew older and procedures more advanced.
In the early years, most pedicle screws were machined from solid titanium or stainless steel. These materials offered excellent strength but lacked the microstructural features necessary for biological integration. Over time, engineers refined thread geometry and introduced variable pitch and dual-lead designs to improve grip and reduce insertion torque.
Despite these incremental advancements, the fundamental design and production process remained largely unchanged—until the introduction of 3D printing technology.
Conventional machining and casting methods have long dictated what’s possible in spinal implant design. While precise, these subtractive manufacturing techniques limit complexity. Internal lattice structures, optimized porosity, and bone-like architectures, key characteristics that enhance osseointegration, were difficult or impossible to achieve.
Additionally, traditional screws had uniform density, meaning they often exhibited a stiffness mismatch between implant and bone. This mismatch could lead to stress shielding, a phenomenon in which bone weakens over time because the implant absorbs too much of the mechanical load.
Even surface coatings and texturing treatments, while helpful, provided only partial solutions. The inability to truly replicate the porous structure of natural bone represented a major design gap, one that directly impacted fusion success and patient outcomes.
The arrival of additive manufacturing, commonly known as 3D printing, marked a turning point in the evolution of spinal implant engineering. Using layer-by-layer fabrication, manufacturers could finally produce complex geometries with unmatched precision.
In spinal surgery, 3D printing has been particularly transformative for titanium spinal screws and interbody cages. This technology enables engineers to design implants that combine high mechanical strength with controlled porosity, characteristics that were previously mutually exclusive.
For pedicle screws, 3D printing offers a level of design freedom that supports both structural and biological optimization. Engineers can now adjust internal lattice configurations to mimic cancellous bone, while maintaining a solid core for strength. This combination results in implants that provide superior mechanical fixation as well as support bone growth and long-term fusion.
The transition from machined to 3D-printed pedicle screws has completely redefined what spinal fixation can achieve. By leveraging additive manufacturing, engineers can now design implants that mirror the intricate structure of natural bone, balancing strength, flexibility, and biological compatibility. This advancement enhances mechanical stability and promotes stronger fusion and long-term patient outcomes, representing a pivotal shift in how spinal implants are conceptualized and produced.
3D-printed titanium screws can feature controlled porosity, allowing bone tissue to grow directly into the implant surface. This bone-on-growth, known as osseointegration, creates a stronger, more stable interface than traditional coatings or textures. As a result, surgeons can expect improved initial fixation and long-term fusion rates.
Additive manufacturing allows precise control over internal structure and density. The screw’s outer threads maintain the rigidity necessary for mechanical load-bearing, while the core can be lightweight yet durable. This balance reduces stress shielding and improves the distribution of mechanical forces across the bone-implant interface.
3D printing empowers engineers to tailor pedicle screw designs for specific anatomical regions or patient populations. Thread geometry, shaft taper, and porosity can all be customized during production. This design flexibility enables future possibilities for patient-specific implants or modular screw systems tailored to different spinal pathologies.
Unlike traditional machining, which removes material from a solid block, additive manufacturing builds each screw from the ground up. This process reduces waste, improves consistency, and allows for faster prototyping and production, benefits that ultimately reach hospitals and distributors in the form of improved efficiency and availability.
Explore Eminent Spine’s innovative portfolio of spinal implants and instrumentation, including the groundbreaking 3D printed pedicle screw system.
A crucial step in the adoption of 3D-printed spinal implants has been achieving U.S. FDA clearance. Regulatory validation not only confirms product safety and efficacy but also sets new standards for innovation across the industry.
In this context, Eminent Spine achieved a historic milestone, pioneering the first FDA-cleared 3D-printed pedicle screw system. This clearance marked a significant advancement in the spinal implant sector, signaling a broader shift toward additive manufacturing as the future of orthopedic device design.
FDA approval carries more than symbolic value. It represents years of engineering, testing, and validation to ensure the screw’s mechanical integrity, fatigue resistance, and biocompatibility. Eminent Spine’s achievement demonstrates that additive manufacturing can meet, and exceed, the rigorous performance standards required for spinal fixation devices.
Surgeons rely on predictable performance and tactile feedback during pedicle screw placement. Traditional designs, while familiar, sometimes introduced concerns about pullout strength or bone purchase in compromised bone quality.
3D-printed designs address these challenges head-on. The porous outer layer improves initial fixation and bone ingrowth, while the internal structure maintains mechanical stability. This dual-benefit design gives surgeons greater confidence in achieving consistent outcomes, particularly in revision cases or osteoporotic bone.
Furthermore, the improved surface texture produced by additive manufacturing enhances screw visualization and placement accuracy under fluoroscopy. As 3D-printed spinal systems become more widely adopted, surgeons will continue to benefit from implants that perform reliably across diverse patient anatomies.
Eminent Spine has consistently pushed the boundaries of spinal implant design, and its success in additive manufacturing reflects that commitment. The company’s 3D-printed pedicle screw represents a synthesis of engineering precision, clinical insight, and material science expertise.
By developing the first FDA-cleared pedicle screw, Eminent Spine positioned itself as a trailblazer in spinal innovation. Its use of titanium additive manufacturing allows for structural complexity and surface porosity that traditional methods could never achieve, all while maintaining the mechanical reliability that surgeons expect from a premium implant system.
This achievement doesn’t only mark a product milestone; it represents a broader evolution in how spinal implants are conceived and produced. Eminent Spine’s approach reflects a shift from merely improving existing devices to rethinking the very foundation of spinal fixation through advanced materials and processes.
The success of Eminent Spine’s 3D-printed pedicle screw system has already influenced the industry’s trajectory. Competing manufacturers are now accelerating their additive manufacturing research, seeking to replicate the same balance of strength, porosity, and biological compatibility.
As hospitals and procurement teams evaluate implant systems, FDA clearance and proven biomechanical performance are becoming the new benchmarks of trust. Distributors and surgeons alike recognize that additive manufacturing is no longer a novelty—it’s the future of spinal implant design.
With additive manufacturing, the possibilities continue to expand. From personalized implant geometries to hybrid fixation systems, 3D printing will continue to shape how spinal stability and patient outcomes are achieved in the years ahead.
From its early origins in solid-machined designs to today’s intricately engineered titanium lattices, the 3D-printed pedicle screw represents a generational leap in spinal fixation. By bridging engineering innovation with clinical needs, Eminent Spine continues to shape the future of spinal implant technology, one precisely printed layer at a time. Contact us today to learn more about our 3D-printed pedicle screw.
https://www.eminentspine.com/wp-content/uploads/2025/09/All-SI-Screw-examples-graphic.png 1250 2000 Abstrakt Marketing /wp-content/uploads/2025/08/ES-Logo-Edit-2.png Abstrakt Marketing2026-01-05 16:21:452026-01-05 17:29:03A Guide to SI Joint Pain: Why It’s Underdiagnosed and How Surgical Fixation Helps
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