标题: FDA Clears 3D-Printed Porous Titanium Cervical Fusion Implant; Providence Completes First Commercial Surgeries [打印本页] 作者: admin 时间: 2026-11-12 10:34 标题: FDA Clears 3D-Printed Porous Titanium Cervical Fusion Implant; Providence Completes First Commercial Surgeries Nanjixiong's introduction: Spine surgery is an important application for 3D-printed implants. Another U.S. spine-device company has received FDA clearance, this time for posterior cervical fusion using a 3D-printed porous titanium lattice to promote bone ingrowth.
On November 10, 2026, Nanjixiong learned that Providence Medical Technology's CORUS PCSS 3D-T posterior cervical fusion fixation system received FDA 510(k) clearance. It is the next-generation porous titanium version of the company's existing machined CORUS PCSS, produced using additive manufacturing.
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Trabecular-bone-inspired lattice: 1.5× surface area and 8× roughness
CORUS PCSS 3D-T is used to stabilize cervical segments affected by degenerative disc disease and is implanted bilaterally through a posterior approach. It retains the surgical technique of the previous CORUS PCSS, while adding a patented titanium lattice modeled on trabecular bone, the spongy tissue inside bone. Its porosity and pore size were designed based on published bone-ingrowth research.
Co-founder Dr. Bruce McCormack gave the following figures:
- Surface area is 1.5 times that of the original machined implant.
- Surface roughness is 8 times that of the original machined implant.
- The lattice distributes loads evenly and provides structural support during fusion.
- Bone-graft material can also be placed inside the implant.
The predecessor has Level I clinical evidence; comparative results for the 3D-printed version have not been published
Providence did not start from scratch with 3D-T. The predecessor CORUS PCSS was studied in a randomized controlled clinical trial (NCT04229017). When used with multilevel anterior fusion, it achieved higher fusion rates at 12 and 24 months and a substantially lower two-year revision rate than anterior fusion alone. Intermediate results were published in the journal Spine in May 2025.
Providence has not yet published comparative clinical results for the 3D-printed version. Its FDA 510(k) clearance followed the substantial-equivalence route based on the predecessor machined implant.
CEO Lane Major said: “CORUS is supported by Level I evidence, which is uncommon in spine surgery. 3D-T builds the porous titanium that spine surgeons increasingly expect onto that proven foundation.”
First commercial surgeries performed on October 29
The company announced on October 29 that the first commercial surgeries had been completed:
- Adventist Health White Memorial Hospital in Los Angeles, California, by Dr. Mohsin Fidai.
- Bon Secours Memorial Regional Medical Center in Mechanicsville, Virginia, by Dr. Abilio Reis.
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Nanjixiong's view
Providence is not the first to move from a mature machined product to a 3D-printed porous titanium version. In 2018, Centinel Spine's FLX platform received FDA 510(k) clearance using the same approach: transferring the existing STALIF design to an all-titanium lattice so surgeons could continue using the same instruments. FLX is anterior, while 3D-T is posterior.
The advantages are clear: existing clinical data need not be repeated, surgeon training requirements are low, and the 510(k) regulatory path is faster. Here, 3D printing is not used to create an entirely new design, but to make the surface of a validated implant rougher and more porous to promote bone ingrowth. For Chinese orthopedic-implant makers, this “new process for an established product” model may be more instructive than pursuing entirely new structures.
Source: 3D Printing Industry
AI-translated from an article by Kuaixiong on Nanjixiong, originally published on 2026-11-10. Text and images retain the original source attribution. Read the original Chinese article
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