TETRAfuse^® 3D Technology is designed to participate in fusion^1,2,†

Studies have shown nano-roughened surfaces enhance protein absorption and bioactivity, improving osteoblast adhesion and tissue growth. ^3-6 Additionally, an average pore size greater than 300μm is recommended to enhance new bone formation. ⁷

• 3D printed nano-rough surface
• Ra=26.7μm
• Macro/Micro structures designed to allow more cells to attach to more of the implant

In an ovine model, histological review of TETRAfuse 3D Technology samples showed deeper implant osseointegration and more notable trabecular bone ingrowth (Table 1) compared to PEEK and titanium (Ti) coated PEEK. ²

TABLE 1: Results from TETRAfuse Ovine Study

† Performance data from animal studies may not be representative of performance in humans.
1. Data on file at RTI Surgical, Inc. Animal and in vitro data may not be representative of clinical experience.
2. Data on file at RTI Surgical, Inc.
3. Webster TJ, Ejiofor JU. Increased osteoblast adhesion on nanophase metals: Ti, Ti6Al4V, and CoCrMo, Biomaterials. 2004, 25: 4731e4739.
4. Bagherifard S, Webster TJ, et. al. The influence of nanostructured features on bacterial adhesion and bone cell functions on severely shot peened 316L stainless steel. Biomaterials. 2015, 73: 185e197.
5. Izquierdo-Barba I, Vallet-Regí M, et. al. Nanocolumnar coatings with selective behavior towards osteoblast and Staphylococcus aureus proliferation. Acta Biomater. 2015, 15: 20-8.
6. Colon G, Ward BC, Webster TJ. Increased osteoblast and decreased Staphylococcus epidermidis functions on nanophase ZnO and TiO2. J Biomed Mater Res A. 2006, 1;78(3):595-604
7. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials. 2005 Sep;26(27):5474-91

TETRAfuse^® 3D Technology’s bone-like mechanical properties

Minimizing the risk for subsidence is a goal for interbody fusion (IBF) implant designs. Some companies try to manage implant stiffness by removing material, potentially making the implant weaker. TETRAfuse 3D Technology is built by adding material, layer by layer. The resulting material has similar characteristics to bone.

TETRAfuse 3D Technology has been shown to:

• Have an elastic modulus similar to bone¹
• Exceed the compressive and torsional strength of PEEK¹
• Increase expulsion resistance by 46% compared to PEEK¹

Figure 1. Elastic Modulus of common IBF/VBR and IBF materials.

Figure 2. Static Testing results of PEEK and TETRAfuse^†

†. Samples tested were of comparable cervical IBF/VBR designs
1. Data on file at RTI Surgical, Inc. Animal and in vitro data may not be representative of clinical experience.
2. MEDSCAPE: Managing Spinal Disorders: Role of Interbody Fusion Technologies. http://www.medscape.org/viewarticle/471966_4
3. Static Axial Compression and Torsion Testing per ASTM F2077 and Static Expulsion Testing per Draft Standard Z8423Z (ASTM F-04.25.02.02)

TETRAfuse^® 3D Technology is radiolucent^2,3

Allowing visualization of the implant and fusion response is ideal when designing a spinal implant. Unlike metal or metal coatings, TETRAfuse 3D Technology is made of a radiolucent, biocompatible polymer. This provides imaging characteristics similar to what you have come to trust from PEEK implants.

Figure 1: X-ray image of Fortilink^®-C IBF implant with TETRAfuse 3D Technology (A), titanium IBF/VBR implant (B), solid titanium IBF/VBR implant (C), and 3D printed titanium IBF/VBR implant (D)

2. Figure 1 (A-C): Data on file RTI Surgical, Inc.
3. Figure 1 (D): https://3dprintingindustry.com/news/stryker-boldy-go-star-trek- inspired-3d-printing-solution-spinal-surgery-97208

TETRAfuse^® 3D Technology’s antibacterial characteristics^2,†

The unique, nano-rough surface features of TETRAfuse 3D Technology including “random nano-pin like patterns” (Figure 1B) create an environment that, without the use of antibacterial chemicals, exhibited decreased bacterial adhesion and growth when compared to PEEK. Importantly, bacteria grew with time (statistically) on PEEK, but not on TETRAfuse 3D Technology.

In a pre-clinical study compared to PEEK, the TETRAfuse 3D Technology’s surface: ²

• Inhibited bacterial attachment and growth over days 1, 3 and 5
• Demonstrated a 40-55% higher antibacterial effect
• Exhibited fewer number of live species after day one of culture (Figure 2)

Figure 1. SEM images of (A) PEEK and (B) TETRAFUSE. Magnification: 40kX, Scale bars: 1 micron.

Figure 2. Live/dead assay of P. aeruginosa attached on PEEK and TETRAfuse samples after 1 day of culture. Scale bars: 10 micron.

2. Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int’l Journal of Nanomedicine. 2017: 12 6471-6476.

† Lab data may not be representative of the effects with all bacteria or performance when implanted in humans. Staphyloccocus epidermidis and Pseudomonas aeruginosa were subject bacterial strains in this study.

Supporting peer reviewed data can be found https://www.ncbi.nlm.nih.gov/pubmed?term=PEKK%20Webster.