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Can 3D Printing Prevent Pedicle Screw Loosening—Is This the Breakthrough Spine Surgery Has Been Waiting For?

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For the first time in history, a company has successfully 3D printed a 5.5 mm diameter pedicle screw capable of withstanding the rigorous testing required for FDA clearance — a goal that many have pursued for decades without success.This milestone represents not just a regulatory achievement, but a breakthrough in the convergence of advanced engineering and biological science.

Why Is Spinal Fusion Still So Challenging?

Spinal fusion remains one of the most common yet challenging procedures in modern spine surgery. Despite decades of innovation, complication rates remain unacceptably high, and patients continue to face difficult recoveries and unpredictable outcomes.

The data reveal a concerning reality:

  • Between 21% and 62% of spinal fusions result in serious or debilitating complications [14,15,16].
  • The most frequent mechanical issue is pedicle screw loosening, affecting 30% to 54% of cases [1,15].
  • More than 5.2 million spinal procedures are performed worldwide each year, increasing at an annual rate of 7.9% [20].
  • Despite the introduction of new materials and designs, lumbar fusion complication rates continue to escalate [21].
  • These failures create a significant financial burden for healthcare systems and pose a serious risk to patient safety [19].
  • At the core of the problem is the unique nature of vertebral bone. Unlike other skeletal structures, it features thinner lattices, larger macropores, smaller micropores, and higher vascularity—with significant variations in shape and density. These characteristics make achieving stable mechanical fixation and biological integration a persistent challenge in spinal fusion surgery.

Why Do Screws Loosen?

The answer lies in the unique complexity of vertebral bone, which features:

  • Thinner lattices
  • Larger macropores
  • Smaller micropores
  • Higher vascularity
  • Significant variation in shape and density

These characteristics make achieving stable mechanical and biological integration an ongoing challenge.

Is INTEGR8™ Porous Pedicle Screw System the Breakthrough Spine Surgery Has Been Waiting For?

The INTEGR8™ System represents a true convergence of engineering precision and biological insight, designed to tackle one of the most persistent challenges in spinal fusion surgery: pedicle screw loosening. By combining advanced structural design with a deep understanding of vertebral bone biology, the system aims to deliver stronger, more reliable, and longer-lasting fusion outcomes.

Key innovations include:

  • Optimized proximal thread topography for enhanced pedicle stability, ensuring screws remain securely anchored even under challenging mechanical loads.
  • Capability to inject biologics tailored to each patient’s specific needs, promoting personalized healing and bone integration.
  • 3D-printed titanium lattice engineered for optimal bone ingrowth and resistance to backout, providing a scaffold that supports natural tissue growth.
  • Internal channels designed to draw and harvest stem cells, enhancing the body’s own regenerative potential directly at the surgical site.
  • Insertion geometry that collects bone and cells during placement, maximizing biological integration from the moment of surgery.
  • 3D-printed porous lattice that mirrors the properties of local bone tissue, creating a more natural interface between implant and vertebrae.

About ALLUMIN8

ALLUMIN8, recognized as “Best Technology in Spine” by leading spine surgeons and “Orthopedics This Week”, is introducing a new category of Therapeutic Orthopedic & Spine 3D Hardware designed to reduce global reoperation rates. Our advanced porous solutions provide surgeons with innovative pathways to diagnose, treat, and heal through the devices, enhancing patient outcomes with the highest level of clinical evidence and cutting-edge technology.Website: www.ALLUMIN8.com

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  1. Lizhen Wang, Huiwen Huang, Hao Yuan, Yan Yao, Jeong Hun Park, Jinglong Liu, Xuezheng Geng, Kuo Zhang, Scott J Hollister, Yubo Fan, In vitro fatigue behavior and in vivo osseointegration of the auxetic porous bone screw, Acta Biomaterialia, Volume 170, 2023, Pages 185-201, ISSN 1742-7061,
  2. Y. Xiong, W. Wang, R. Gao, H. Zhang, L. Dong, J. Qin, B. Wang, W. Jia, X. Li, Fatigue behavior and osseointegration of porous Ti-6Al-4V scaffolds with dense core for dental application, Mater. Des., 195 (2020), Article 108994
  3. R. Dhandapani, P.D. Krishnan, A. Zennifer, V. Kannan, A. Manigandan, M.R. Arul, D. Jaiswal, A. Subramanian, S.G. Kumbar, S. Sethuraman, Additive manufacturing of biodegradable porous orthopaedic screw, Bioact. Mater., 5 (3) (2020), pp. 458-467
  4. Y. Wang, X. Chen, C. Zhang, W. Feng, P. Zhang, Y. Chen, J. Huang, Y. Luo, J. Chen, Studies on the performance of selective laser melting porous dental implant by finite element model simulation, fatigue testing and in vivo experiments, Proc. Inst. Mech. Eng. Part H J. Eng. Med., 233 (2) (2019), pp. 170-180
  5. Sebastien J.P. Callens, Duncan C. Tourolle né Betts, Ralph Müller, Amir A. Zadpoor, The local and global geometry of trabecular bone, Acta Biomaterialia, Volume 130, 2021, Pages 343-361, SSN 1742-7061, https://doi.org/10.1016/j.actbio.2021.06.013.
  6. Zou, D., Muheremu, A., Sun, Z., Zhong, W., Jiang, S., & Li, W. (2020). Computed tomography Hounsfield unit–based prediction of pedicle screw loosening after surgery for degenerative lumbar spine disease. Journal of Neurosurgery: Spine SPI, 32(5), 716-721. https://doi.org/10.3171/2019.11.SPINE19868
  7. D.G. Kim, S.S. Huja, B.C. Tee, P.E. Larsen, K.S. Kennedy, H.H. Chien, J.W. Lee, H.B. Wen, Bone ingrowth and initial stability of titanium and porous tantalum dental implants: a pilot canine study, Implant Dent., 22 (4) (2013), pp. 399-405
  8. F. Yang, C. Chen, Q. Zhou, Y. Gong, R. Li, C. Li, F. Klaempfl, S. Freund, X. Wu, Y. Sun, X. Li, M. Schmidt, D. Ma, Y. Yu, Laser beam melting 3D printing of Ti6Al4V based porous structured dental implants: fabrication, biocompatibility analysis and photoelastic study, Sci. Rep., 7 (2017)
  9. R. Agarwal, V. Gupta, J. Singh, Mechanical and biological behaviour of additive manufactured biomimetic biodegradable orthopaedic cortical screws, Rapid Prototyp. J., 28 (9) (2022), pp. 1690-1705
  10. P. Trueba, C. Navarro, M. Giner, J.A. Rodriguez-Ortiz, M.Jose Montoya-Garcia, E.J. Delgado-Pujol, L.M. Rodriguez-Albelo, Y. Torres, Approach to the fatigue and cellular behavior of superficially modified porous titanium dental implants, Materials, 15 (11) (2022)
  11. The hydroxyapatite modified 3D printed poly L-lactic acid porous screw in reconstruction of anterior cruciate ligament of rabbit knee joint: a histological and biomechanical study, BMC Musculoskelet. Disord., 24 (1) (2023)
  12. S. Van Bael, Y.C. Chai, S. Truscello, M. Moesen, G. Kerckhofs, H. Van Oosterwyck, I.P. Kruth, J. Schrooten, The effect of pore geometry on the in vitro biological behavior of human periosteum-derived cells seeded on selective laser-melted Ti6Al4V bone scaffolds, Acta Biomater., 8 (7) (2012), pp. 2824-2834
  13. S.J.P. Callens, D. Fan, I.A.J. van Hengel, M. Minneboo, P.J. Diaz-Payno, M.M. Stevens, L.E. Fratila-Apachitei, A.A. Zadpoor, Emergent collective organization of bone cells in complex curvature fields, Nat. Commun., 14 (1) (2023), p. 855
  14. Anmol Gupta, Thomas Cha, Joseph Schwab, Harold Fogel, Daniel Tobert, Afshin E. Razi, Andrew Hecht, Christopher M. Bono, Stuart Hershman,, Osteoporosis increases the likelihood of revision surgery following a long spinal fusion for adult spinal deformity, The Spine Journal,, Volume 21, Issue 1,, 2021,, Pages 134-140, ISSN 1529-9430, https://doi.org/10.1016/j.spinee.2020.08.002.
  15. Rollinghoff M, Schluter-Brust K, Groos D, Sobottke R, Michael JW, Eysel P, Delank KS. Mid-range outcomes in 64 consecutive cases of multilevel fusion for degenerative diseases of the lumbar spine. Orthop Rev. 2010;2(1):e3.
  16. Mahesh B, Upendra B, Vijay S, Kumar GA, Reddy S. Complication rate during multilevel lumbar fusion in patients above 60 years. Indian J Orthop. 2017 Mar-Apr;51(2):139-146. doi: 10.4103/0019-5413.201704. PMID: 28400658; PMCID: PMC5361463.
  17. Writer, Staff. “Pedicle Screw Systems Market Set to Hit $3.4 Billion in 2027.” Spinal Surgery News, 21 Apr. 2022, www.spinalsurgerynews.com/2022/04/pedicle-screw-systems-market-set-to-hit-3-4-billion-in-2027/91010.
  18. Yang, Y., Xu, T., Bei, H., Zhang, L., Tang, C. Y., Zhang, M., … & Zhao, X. (2022). Gaussian curvature–driven direction of cell fate toward osteogenesis with triply periodic minimal surface scaffolds. Proceedings of the National Academy of Sciences, 119(41). https://doi.org/10.1073/pnas.2206684119
  19. Chris Centeno, MD. “How Much Does Low Back Fusion Cost?” Regenexx, 27 Feb. 2022, regenexx.com/blog/how-much-does-low-back-fusion-cost/.
  20. Spine Surgery: Global Trends & Opportunities.” Spine Surgery | Global Trends & Opportunities 2018 – Life Science Intelligence, www.lifesciencemarketresearch.com/market-reports/spine-surgery-global-trends-opportunities-procedure-volumes-analysis-2018. Accessed 8 Dec. 2023.
  21. Daniell, James R, and Orso L Osti. “Failed Back Surgery Syndrome: A Review Article.” Asian Spine Journal, U.S. National Library of Medicine, Apr. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC5913031/.
  22. SPINEMarketGroup. “What Is Our Estimate of Spine’s Market Shares by the End of 2022?” SPINEMarketGroup, 6 Jan. 2023, thespinemarketgroup.com/what-is-our-estimate-of-spines-market-shares-by-the-end-of-2022/.