3D Titanium Pedicle Screw

The only 510(k) FDA 3D titanium pedicle screw approved in the world.

Revised Screw

History

  • 1985

    21 Years Old

    1985 Image

    A Biomechanical Analysis of the Steffee- Plated Thoracolumbar Spine

    Stephen P. Courtney; Subrata Saha, Ph.D; John M. Lipka, M.S.; and James A Albright, M.D., Edward Benzel, M.D.

    Louisiana State University Medical Center Department of Orthopaedic Surgery
    P.O. Box 33932
    Shreveport, Louisiana 71130

  • 2008

    Founded Eminent Spine

    Vertical 3d Screw Image

    14 US-FDA 510(k) implant systems, Hundreds of US patents granted

    Extensive Implant Master Files, DHR, sterilization & validation files, quality control, biocompatibity files

    The accumluation of spinal systems, research, biomechanical testing and compounding 40 Years of Data lead to the development & successful US-FDA 510(k) approval of the only 510(k) FDA 3D titanium pedicle screw approved in the world.

  • 2025

    61 Years Old

    Vertical 3d Screw Image

    April 28th, 2025

    Eminent Spine
    Stephen Courtney
    Chief Executive Officer
    2004 Ventura Dr.
    Ste 100
    Plano, Texas 75093

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Features

  • Proprietary Patented Pedicle Screw Technology
  • 100% 3D Printed Pedicle Screw Shank
  • Cortical/Cancellous hybrid thread pattern
  • Triple lead screw technology for ease of insertion and greater pull out strength
3d Printed Pedicle Screw Features Diagram

Osteo-integrated with the Bone

Osteo Integrated Image
3d Printed Pedicle Screw Measurements Diagram 2

Screw Options

Cannulated & Non-Cannulated

DiameterLength
6.00mm40-60mm | 5mm
6.50mm40-60mm | 5mm
7.00mm35-60mm | 5mm
7.50mm35-60mm | 5mm
8.00mm35-60mm | 5mm
Cannulated Image

Cannulated

Non Cannulated Image

Non-Cannulated

“Where Innovation Meets Integration”

Electronic Microscope: See the Difference

Machined Titanium Image

Machined Titanium

Surfaced Titanium Image

Surfaced Titanium

3d Printed Titanium Image

3D Printed Titanium

How This New Technology Is Beneficial for The “Patient”

  • Minimized Screw Loosening

    The 3D Printed surface helps reduce the risk of screw loosening, making these screws effective in both normal and osteoporotic bone conditions.

  • Accelerated Osseointegration

    The 3D Printed technology creates an osteoblastic environment that speeds up the osseointegration process, leading to faster healing and improved stability.

  • Enhanced Bonding and Bone Growth

    The 3D Printed surface promotes better integration with the bone, facilitating stronger bonds and encourages natural bone growth around and through the screws.

  • Porosity Control

    3D printing technology can create porous designs and the creation of intricate structures that promote bone ingrowth, enhance integration with the bone and the stability and longevity of the implant.

Bone Scan Image 1
Bone Scan Image 2

3D Printed Lattice Technology

  • 3D Lattice Design for faster fusion, promoting bone ingrowth for enhanced stability, strength and longevity
  • Printing technology has advanced to mimic bone that can now correlate with human bone trabecular
  • Alternative lattice compared to traditional screws
  • Provides optional Osteoblastic environment for bone growth and fusion
  • Lattice on the threads provides more surface area for Osteoblastic activity
  • Design to Harvest bone instead of Displacing bone cells compared to conventional machined pedicle screws

Features

  • 100% 3D Printed Pedicle Screw Shank
  • Triple lead screw technology for ease of insertion and greater pull out strength
Vertical 3d Screw Image

3D lattice Osteo-integrated with the Bone

Osteo Integrated Image
Compression Result Machine 2 Alt
Compression Result Machine 3 Alt
  • Dynamic Compression test results exceeded FDA acceptable criteria compared to traditional Machined Titanium Pedicle Screws
  • Over 75 Million dynamic compression cycles performed Typical standard is <25 million cycles
  • Rod fractured NOT the Neck of the 3D pedicle screw
Torsional Test Image 1
Torsional Test Image 3
Torsional Test Image 4
Torsional Test Image 2
  • Torsional test results exceeded FDA acceptable criteria compared to traditional Machined Titanium Pedicle Screws
  • MTS Screw driver shank fractured NOT the Neck of the 3D pedicle screw
  • Gradual design of stress transfer from Neck to Cortical screw section

Why?

Continue to have Disastrous Complications despite Technical Advancement in Technology.

  • Most common mechanical failure is 10-60% of pedicle screws become Loose
  • Screw Loosening and Pull-out are failures in the early stages of fusion
  • Screw Loosening and Breakage of lumbar pedicle screw most common complication affecting spinal stability
  • Screw Loosening is associated with Pseudoarthrosis and Back pain Fatigue facture due to toggling with cyclic loading
  • Results in high complication rate and serious debilitating complications:
    • Infections
    • Psueoarthrosis
    • Screw breakage
    • Kyphosis Results in Massive increase cost
    • Revision rate and Morbidity 20% reoperation rate in Adult Deformity
  • Screw losing common in Long Construct & Scoliosis fusions
  • Fusion to the Sacrum, Revision Surgery
  • Postoperative TLK greater than 10°
  • SVA imbalance, Lateral subluxation greater than 8mm
  • Osteopenia & Osteoporosis
  • Lumbar Fusion Surgery
  • Average life expectancy is longer
  • Estimated 50 million people in America dx with Osteoporosis (Worldwide currently 200 million)
  • Projected Global by 2030 is estimated to reach 236 million
  • Increase older population will result in increase Osteoporosis
    • 1 in 3 women & 1 in 5 men over age of 50
    • 50% of people over age of 70
  • Prevalence of Osteoporosis will increase with aging population
  • Additive manufacturing technology has advanced to mimic bone that can now correlate with the human bone trabecular
  • Hopefully this should provide a meaningful impact on Screw Loosening in the elderly aging osteoporotic population, and will lead to a decrease complication and re-operation rate
  • Both in Osteoporotic and Non-Osteoporotic patients
  • Spine Scan 4
  • Spine Scan 3
  • Spine Scan 5
  • Spine Scan 2
  • Spine Scan 1
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Mechanical Design

  • More than 5 years of Extensive Research
  • Design concept, prototype, biomechanical testing, evaluating the results
  • Re-design, re-testing and re-defining the parameters and specific values to increase strength of the screw
  • Using that data along with Finite Element Analysis (FEA) we were able to Surpass the FDA criteria for Torsional strength, Dynamic and Torsional stresses and Static stiffness
  • Along with other extensive rigious unique ASTM battery of testing Extensive open discussion and interaction with the FDA due to the Novel concept & design

Resulted in the Correct & Final Screw Design of the only 510(k) FDA 3D titanium pedicle screw approved in the world.

Surgical Technique: 3D Titanium Pedicle Screw System
IFU: 3D Titanium Pedicle Screw System
Case Studies: 3D Titanium Pedicle Screw System

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Note: Instruments for these procedures are available per request. Contact us today for more information regarding our instrumentation.

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Eminent Spine

Eminent Spine is dedicated to manufacture biomechanically sound spinal implants and focus on surface technology.

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