FDA approval for 3D printed titanium implant

2016 ◽  
Vol 71 (5) ◽  
pp. 364
2020 ◽  
Vol 10 (2) ◽  
pp. 553 ◽  
Author(s):  
Jong Woong Park ◽  
Chae Ahn Song ◽  
Hyun Guy Kang ◽  
June Hyuk Kim ◽  
Kwun Mook Lim ◽  
...  

A titanium alloy implant of appropriate pore size can potentially enhance osseointegration and soft tissue integration. However, the human clinical application of such implants has not been reported. Here, we present a case of limb salvage surgery for a bone tumor using customized three-dimensional (3D)-printed Ti6Al4V radius and ulna implants. The patient presented with local recurrence at the proximal junction of the ulna and underwent a re-wide excision. Single forearm bone surgery was performed using another 3D-printed implant after resection of the recurrent tumor with an ulnar implant. Host osseointegration and soft tissue integration of the retrieved implant were quantified through histological evaluation. The total tissue integration rates of the implant at the proximal and distal bone junctions were 45.96% and 15.03%, respectively. The mesh structure enhanced bone integration by up to 10.81% in the proximal and by up to 8.91% in the distal bone junction. Furthermore, the soft tissue adhesion rates of the implant shaft were 59.50% and 50.26% in the axial and longitudinal cuts, respectively. No area was left unoccupied throughout the shaft of the implant. Overall, these results indicate that the 3D-printed Ti6Al4V titanium alloy implant with a rough surface has considerable tissue integration ability.


Author(s):  
Weiyang Zhong ◽  
Jianxiao Li ◽  
Chenbo Hu ◽  
Zhengxue Quan ◽  
Dianming Jiang ◽  
...  

2021 ◽  
Vol 10 (16) ◽  
pp. 3509
Author(s):  
Guido R. Sigron ◽  
Marina Barba ◽  
Frédérique Chammartin ◽  
Bilal Msallem ◽  
Britt-Isabelle Berg ◽  
...  

The present study aimed to analyze if a preformed “hybrid” patient-specific orbital mesh provides a more accurate reconstruction of the orbital floor and a better functional outcome than a standardized, intraoperatively adapted titanium implant. Thirty patients who had undergone surgical reconstruction for isolated, unilateral orbital floor fractures between May 2016 and November 2018 were included in this study. Of these patients, 13 were treated conventionally by intraoperative adjustment of a standardized titanium mesh based on assessing the fracture’s shape and extent. For the other 17 patients, an individual three-dimensional (3D) anatomical model of the orbit was fabricated with an in-house 3D-printer. This model was used as a template to create a so-called “hybrid” patient-specific titanium implant by preforming the titanium mesh before surgery. The functional and cosmetic outcome in terms of diplopia, enophthalmos, ocular motility, and sensory disturbance trended better when “hybrid” patient-specific titanium meshes were used but with statistically non-significant differences. The 3D-printed anatomical models mirroring the unaffected orbit did not delay the surgery’s timepoint. Nonetheless, it significantly reduced the surgery duration compared to the traditional method (58.9 (SD: 20.1) min versus 94.8 (SD: 33.0) min, p-value = 0.003). This study shows that using 3D-printed anatomical models as a supporting tool allows precise and less time-consuming orbital reconstructions with clinical benefits.


Author(s):  
Jung-Hyun Park ◽  
Michidgerel Odkhuu ◽  
Sura Cho ◽  
Jingwen Li ◽  
Bo-Young Park ◽  
...  

Materials ◽  
2022 ◽  
Vol 15 (2) ◽  
pp. 576
Author(s):  
Yen-Wen Shen ◽  
Yuen-Shan Tsai ◽  
Jui-Ting Hsu ◽  
Ming-You Shie ◽  
Heng-Li Huang ◽  
...  

Clinically, a reconstruction plate can be used for the facial repair of patients with mandibular segmental defects, but it cannot restore their chewing function. The main purpose of this research is to design a new three-dimensionally (3D) printed porous titanium mandibular implant with both facial restoration and oral chewing function reconstruction. Its biomechanical properties were examined using both finite element analysis (FEA) and in vitro experiments. Cone beam computed tomography images of the mandible of a patient with oral cancer were selected as a reference to create 3D computational models of the bone and of the 3D-printed porous implant. The pores of the porous implant were circles or hexagons of 1 or 2 mm in size. A nonporous implant was fabricated as a control model. For the FEA, two chewing modes, namely right unilateral molar clench and right group function, were set as loading conditions. Regarding the boundary condition, the displacement of both condyles was fixed in all directions. For the in vitro experiments, an occlusal force (100 N) was applied to the abutment of the 3D-printed mandibular implants with and without porous designs as the loading condition. The porous mandibular implants withstood higher stress and strain than the nonporous mandibular implant, but all stress values were lower than the yield strength of Ti-6Al-4V (800 MPa). The strain value of the bone surrounding the mandibular implant was affected not only by the shape and size of the pores but also by the chewing mode. According to Frost’s mechanostat theory of bone, higher bone strain under the porous implants might help maintain or improve bone quality and bone strength. The findings of this study serve as a biomechanical reference for the design of 3D-printed titanium mandibular implants and require confirmation through clinical investigations.


Bone Reports ◽  
2020 ◽  
Vol 13 ◽  
pp. 100612
Author(s):  
Jinwoo Kim ◽  
Michidgerel Odkhuu ◽  
Jung-Hyun Park

2021 ◽  
Vol 29 ◽  
Author(s):  
RYU Jaeyoung ◽  
Hyo-Sun KANG ◽  
Byung-Hun KANG ◽  
Seunggon JUNG ◽  
Min-Suk KOOK ◽  
...  

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