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3D-printed PEEK-based Spine Implant Cleared by FDA
The first 3D-printed spinal implant fabricated from Invibio Biomaterial Solutions’ PEEK-Optima polymer has received FDA clearance. The PEEK Interbody System is marketed by Nvision Biomedical Technologies, a medical device and implant manufacturer based in San Antonio, TX.
First of its kind
The system consists of cervical and anterior lumbar interbody fusion (ALIF) spine devices. Each element incorporates extensive porous structures that have the potential to promote multi-directional bone ingrowth and improve device fixation. The system reportedly is the first device of its kind made from PEEK-Optima using the proprietary Bond3D additive manufacturing technology that enables printing of solid and porous areas.?
PEEK-Optima has already been used in more than 15 million implants. Its mechanical properties resemble those of human bone and it is superior to titanium implants because of its imaging capability, which allows surgeons to more accurately monitor fusion progression, said Invibio.
The collaboration between Invibio and Nvision dates back several years, particularly in spine and foot-and-ankle devices. In 2020, Nvision received 510(k) clearance from FDA for an osteotomy wedge system made from Invibio’s PEEK-Optima HA Enhanced polymer.
Improved outcomes
The new interbody devices will improve the quality of care and surgical outcomes for patients, according to Dr. Steven Lee, MD, a spine and orthopedic surgeon cited in the press release. “PEEK-Optima’s modulus of elasticity helps to prevent subsidence [sinking of bone next to an implant]. Its radiolucency allows for the confirmation of the fusion process.?The benefit of a printed porous structure that mimics native bone allows for bone growth into the device itself, thereby enhancing the construct stability.?These combined new implant characteristics of strength, reduced subsidence, boney ingrowth, and radiolucency will provide clinical benefits to all my patients,” said Lee.
Nvision and Invibio collaborated in the development of the 3D-printed PEEK Interbody System, with Invibio carrying out development of the PEEK-Optima and Bond3D technology platform, performance testing early in the process, and eventually filing a new master file (MAF) with FDA to support this and future regulatory submissions.
Nvision and Invibio said they intend to continue expanding the applications of 3D-printed PEEK technology to meet the growing needs of surgeons and patients worldwide.
Celanese Ahead of the Curve on Recycled Plastics for Auto Sector
European Union (EU) legislation mandating certain levels of plastic recyclate content in automobiles is leading to accelerated initiatives by automakers to develop?materials ?and?infrastructure ?to ensure supply availability come the early 2030s, when 25% recycled content will be signed into law. In a recent webinar, materials supplier Celanese outlined its approach to delivering on solutions to assist in the realization of recycled content targets.
“More than six million cars reach end of life [annually in Europe], and there's a lot of plastic content in those cars,” noted Oliver Kuisle, sustainability leader EU at Celanese. Further, the materials supplier estimates that 20 to 40% of automotive shredder residue (ASR) is plastic and is ultimately landfilled or incinerated. Kuisle also noted that impending EU legislation will be applied to all cars sold in Europe, not just those manufactured there.
Grade segregation
Celanese’s portfolio of recycled content engineering plastics currently includes:
Most grades on offer from Celanese are supplied using the segregated approach, meaning a Celanex PBT/PET blend with minimum 25% recycled content, for example,?actually contains that ratio of PCR PET. Rynite PET grades with up to 100% PCR PET content are offered, with a product carbon footprint (PCF) reduction of up to 59%.
In terms of performance, while each grade will have its own map, a PA 6 grade with 35% glass-fiber reinforcement, cited as an example by Celanese, exhibits no drop-off in tensile modulus, while the notched Sharpy impact strength, stress, and strain performance are in the ranges that can be expected for the respective performance tolerances.
Mass-balance polyamide
Celanese has opted for the mass-balance approach for commercially available grade Zytel 70G30HSLR ECO-0R 312 BK099, which is a 30% glass-fiber-reinforced material. The ISCC+ third-party certified material offers a seamless transition to recycled materials with a 30% allocation of recycled content.?
Celanese can extend this mass-balance approach to a range of different offerings, from glass-filled to unfilled toughened grades, through medium toughened and super-toughened grades, to a smaller number of glass-filled and toughened combination grades. “This is a great way to maintain your performance and get that recycled content to help meet your targets,” said Micheal Chisholm, sustainability leader AM at Celanese.
“We have a large portfolio, but we are continually working to bring more solutions to market,” added Chisholm. These include flame-retardant grades in the PA 66 sphere, as well as a Zytel HTN51 high-temperature polyphthalamide semi-aromatic PA grade based on PIR PA.?
Recycled input quality assurance
Key to successful delivery of recycled content solutions is ensuring the quality of the recycled inputs. “[Here], we don't really make a difference between post-consumer, post-industrial, or virgin feedstock,” says Kuisle. “We demand the same quality standards —?we don't make any concessions —?and it's by engaging with our recycled feedstock suppliers by way of agreements and long-term contracts [that we ensure quality].”
Mechanical properties of recycled content grades are within performance tolerances of fossil fuel–based materials. Image Courtesy of Celanese.
“We're working with our suppliers as a key driver of success in this arena, and then internally, from Celanese, we have controlled blending approaches and quality controls that we use to help ensure consistent performance and quality in all the products we sell,” added Chisholm.
Audience survey highlights hidden interior applications
An attendee survey during the webinar indicated that while 33% of respondents were exploring all options when it came to the use of recycled content grades, an equal 33% identified “interior – hidden” for priority implementation of recycled solutions. At the other extreme of implementation, only 6% of attendees cited “interior – visible” as highest on the agenda, perhaps due to concerns about aesthetics. LyondellBasell and OEM Dacia, however, have demonstrated how recycled content might be?leveraged ?as an inherent design aspect. The EVA battery and powertrain also scored 6% among respondents, perhaps due to concerns regarding mechanical strength and flame retardance.
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And the Ig Nobel Award Goes to Plastics Research by Way of Drunk Worms
The Ig Nobel Prizes are sort of a spoof award, given annually to researchers who study unusual topics. The common thread of the winners is that their research can be made to sound ridiculous.
Making fun of unusual research is nothing new. You may remember Senator Proxmire from Wisconsin, who would monthly give out a “Golden Fleece Award” for squandering public money, much of which went to researchers whose work made for a good punchline. Going further back, Jonathon Swift devoted several pages of Gulliver’s Travels to mocking the "dubious" research that was carried out back in his lifetime (around 1700). Clearly, non-technical people questioning the value of research is nothing new.
A serious spoof
I led in with a description of the Ig Nobels as sort of a spoof award. The awarding organization is quite clear, however, that the winners are researching topics that at first make you laugh, but then also make you think. There is something serious behind all the humor —?they’re not just mocking what appears to be wasteful spending.
One of the 2024 winners involves a topic that is related to plastics in a non-obvious fashion. Their research involved drunk worms racing sober worms. A non-obvious fashion? Maybe a very non-obvious fashion. Let me explain.
Wiggle with a purpose
One parallel between worms and the polymer chains that make up plastics should be obvious — both are long and thin, but the similarities stop there. While worms wiggle, as do polymer chains, the outcome is quite different. At any temperature when a plastic is non-solid, the chains are randomly jostled in all directions. Unlike with worms, all this back-and-forth motion doesn’t move the polymer chains anywhere, as the randomness of the motion cancels itself out. If you could look at an individual polymer chain and mark its location, it would still be there later on. By contrast, worms are able to take their wiggling and turn it into directed motion.
A class of plastics known as “active polymers” can act like worms and be directed toward specific locations. To explain how this happens would require an exciting set of lectures — Don’t forget what my day-job is! —?so let’s just accept that it happens. (But there will be a quiz at the end of this article.)
What drunk worms can tell us about inactive polymers
Worms are much easier to study than individual polymer chains because of their macroscopic size. The researchers needed something that could simulate less active or inactive polymers, and so drunken worms were used. (Surprisingly, they sober up in about 10 minutes, so you have to work fast.) The results showed that this setup can be used to mimic what happens with active polymers, but the results are so much easier to achieve. That’s the connection between drunk worm races, plastics, and this year’s Ig Noble Prizes.
Laughing is perfectly natural, but following that up by thinking is pretty uncommon. Not enough people dig deep enough to reach the thinking stage. Pretty much any research can be misconstrued and mocked: Being neck-deep in election campaigns, you know all too well that pretty much anything a person says can be misconstrued and mocked! Taking the time to dig to the bottom and recognize that your initial perceptions are probably wrong and that you’re missing something takes, well, time, and who has a surplus of that? It’s ok to question others, but you need to question yourself just as much.
ExxonMobil Shakes Up Its Polymers Business
ExxonMobil is radically transforming its polymers business by launching its Signature Polymers group, a broad-ranging initiative to reshape the company’s approach to product positioning and partnerships while influencing and educating the plastics industry.
The Signature Polymers brand will encompass all of ExxonMobil’s polyolefin products and leverage multiple new approaches toward making the brand “the industry’s most valued global partner through improved service and partnership,” the company said.
Only the names have changed
“Over the next year we will transition some of our brands and grade names to better reflect the attributes and benefits they provide,” said ExxonMobil Global Brand Manager Alechia Crown.?“We’ll have fewer, more significant brands.?Our high-quality polymers aren’t changing, just the names.”
The new group will standardize ExxonMobil’s Signature Polymers portfolio and improve portfolio navigation and product selection through simpler naming.
Cementing unity in plastics value chain
Additionally, the Signature Polymers group will pursue its goal to unite the broader plastics value chain through:
As the plastics industry faces continued challenges, “we believe our position as a leading global polyolefins supplier puts us in a unique position to deliver a new level of service and partnership to our customers,” said Juhan Robberts, senior vice president for ExxonMobil. “We are elevating our customer experience and launching our new brand structure as a commitment to this promise to deliver enhanced service and partnership.“
Recommended Reads ??
5?? Bags, Bottles, and Brands: September’s Top 5 in Plastic Packaging: These articles caught the attention of plastics professionals the past month.
? 3D Printing Takes the Stage at Advanced Manufacturing Minneapolis: With a keynote presentation, six sessions, and multiple exhibitors, additive manufacturing plays a major role at the October show.
?? A Quantum Leap for Quality Control in Plastic Injection Molding: A research project is exploring new avenues for AI-assisted automated optical quality assurance during the injection molding process.
?? Patient Receives World’s First All-Plastic Ankle Implant: The PEKK-based implant will maintain mobility for the 71-year-old with a lifelong metal allergy.
?? Plastics Extrusion Businesses Respond to Demand: Pexco acquires extruder K. Jabat and Canada’s Soleno opens its first US factory to produce HDPE pipes for infrastructure applications.
?? Upcoming Industry Events
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