3D Titanium Pedicle Screw

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

History

1985
21 Years Old

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

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

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

Osteo-integrated with the Bone

3d Printed Pedicle Screw Measurements Diagram 2

Screw Options

Cannulated & Non-Cannulated

Diameter	Length
6.00mm	40-60mm \| 5mm
6.50mm	40-60mm \| 5mm
7.00mm	35-60mm \| 5mm
7.50mm	35-60mm \| 5mm
8.00mm	35-60mm \| 5mm

Cannulated

Non-Cannulated

“Where Innovation Meets Integration”

Electronic Microscope: See the Difference

Machined Titanium

Surfaced Titanium

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.

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

3D lattice Osteo-integrated with the Bone

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 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.

“3D pedicle screw is the Right 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

Risk Factors

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

Osteoporosis

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

Solution

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

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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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3D Titanium Pedicle Screw

History

1985

21 Years Old

2008

Founded Eminent Spine

2025

61 Years Old

Features

Screw Options

Electronic Microscope: See the Difference

How This New Technology Is Beneficial for The “Patient”

Minimized Screw Loosening

Accelerated Osseointegration

Enhanced Bonding and Bone Growth

Porosity Control

3D Printed Lattice Technology

Features

Why?

Mechanical Design

Contact Us Today

Eminent Spine

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