There was a way to meet or exceed metal’s performance and complex design innovation, most surgeons would take a long hard look at polymer manufacturing for five major reasons:

• Metal complicates post-operative visualization
• Metal often leads to stress shielding and loosening
• Metal implants can’t be modified by the surgeons in the O.R.
• Some patients may have an allergic response to metal
• Biofilm formation and infection risks increase with using metal
• This leads us to Scott Defelice’s obsession.

Scott DeFelice’s Obsession

Scott DeFelice is CEO and founder of Oxford Performance Materials (OPM), the first company to successfully 3D print using high-performance poly-ether-ketone-ketone (PEKK) material. In 2013, with its cranial prosthesis, OPM became the only firm to receive FDA approval to 3D print polymeric implants before receiving a second 510(k) for patient-specific facial implants in 2014. In addition to being a leader in the medical 3D printing sector, OPM has an Aerospace & Industrial branch where it has been using its proprietary OXPEKK materials technology in space and defense aircraft.   

PEKK is at the top of the food chain thermoplastic in the thermoplastic world. It is a high-performance polymer due to its excellent chemical, thermal, and mechanical characteristics and biocompatibility.

We currently hold a wide range of patents and intellectual property, ranging from how PEKK is made synthetically to how it is processed, how to manufacture powders for 3D printing, and how to print using the material.

In terms of 3D printing, our activities started around 10 years ago with the development of a selective laser melting technique to 3D print with PEKK. We launched the first commercial 3D-printed devices around 2006 for the medical field and that was the beginning of 3D printing development. 

In 2008, the FDA cleared our first device, which was a cranial implant for patients and distributed worldwide by Zimmer Biomet. We are constantly producing facial and cranial implants. 

We moved from there to spinal implants over three years ago, and those products are sold in partnership with an organization named RTI Surgical. We have shipped over 70,000 spinal implants till now. 

Most recently, we have received another FDA clearance in a sports medical application for suture anchors which are used to surgically reattach soft tissue to bone. 

In parallel, we developed and validated our technology for use in space and defense applications and received certification from Boeing and Northrop Grumman, among others. 

OPM is coming at the 3D printing business, not from the perspective of people who were, say, in prototyping and then moved into production parts. We’re coming at it from the perspective of an advanced materials company who found that their material would be very good for additive manufacturing, due to interesting technical reasons. 

PEKK in 2024

DeFelice has been achieving significant PEKK achievements since 2006:

• 2006: first machined PEKK spinal cages
• 2010: FDA clears first PEKK tissue marker
• 2012: FDA clears first PEKK craniomaxillofacial device (OsteoFab)
• 2015: The FDA approves the first OsteoFab PEKK VBR, a spinal implant.
• 2016: PEKK Wins Best Technology in Spine Award
• 2017: The FDA approves PEKK spine implants produced using the OsteoFab method.
• 2019: FDA approves PEKK suture anchor for multiple indications

In addition to 3D printing PEKK implants, OPM sells PEKK in powder, pellet, and rod forms.

Based on Product Types the Market is divided into the following categories that held the largest Polyetherketoneketone or PEKK market share In 2024.

• Electrophilic Substitution
• Nucleophilic Substitution

The Global Polyetherketoneketone (PEKK) Market Research Report offers a comprehensive review of market conditions over the forecast period with a complete analysis of the leading competitors, including price dynamics, industry trends, and strategic evaluations. It also highlights major industry participants, strategic partnerships, mergers and acquisitions, and the latest innovations shaping the market landscape.

According to the latest research, the global Polyetherketoneketone or PEKK market will grow in the next 5 years. As of 2024, the global Polyetherketoneketone or PEKK market was estimated at USD 63.2 million, and it’s projected to reach USD 116.14 million in 2031, with a CAGR of 10.67% during the forecast years.

PEKK replaces metal used in Mercedes-Benz gearbox gears:

High-performance polymers like Polyetheretherketone or PEKK offer many useful opportunities for gear improvement. 

Mass balancer gears made up of Vestakeep 5000 G are the first polymer gears that are used in Mercedes-Benz transmissions. It replaces the previously used metal gear.

Plastic gears are gradually replacing metal gears in numerous technical applications because they are lighter, quieter, have good dry-running properties, have low friction and wear, and can be manufactured efficiently. Products made of high-performance plastics such as polyetheretherketone or PEKK are generally more stable mechanically, thermally, and chemically than gears made of engineering plastics and thus enable extended load limit values. An important prerequisite for this is conformity assessment and appropriate component design for the type of plastic.

In 2018, a Competence Centre for Tribology was founded in Darmstadt, Germany, to develop high-performance plastics for the manufacture of components such as PEKK, polyamide 12 (PA12), and polyimide (PI). 

Metal: Excessively rigid, powerful, and prone to infection

As OPM’s CEO Scott DeFelice told OTW: “Cobalt and Titanium plating have served the industry for decades for millions of patients, metal structures can be too strong, too stiff, and the endemic formation of biofilm on metal implants significantly raises infection risk.”

“PEKK essentially solves all these problems. It’s mechanically right. It’s biologically right. Bone grows on it. It prohibits infection. There’s very limited bacterial colonization.”

PEKK or Polyetheretherketone Is Kicking Metal to the Curb in Performance Engineering Applications:

In the thermoplastic industry, some materials reign supreme. Among these, PEKK (polyetheretherketone) is king. This polymer has several benefits over traditional metal fabrication.

PEKK or polyetheretherketone has the strength and durability of metal, but at a fraction of the weight and resists chemicals and hydrolysis. It’s these qualities that allow PEKK polymers to replace metals in precision-engineered components.

Conclusion:

From traditional automotive engineering to robotics to drones, the potential users for plastic gears are extremely diverse. High-performance polymers like PEKK expand the use of plastic gears in transmissions to higher torque, speed, and temperature ranges. 

PEKK is not a low-cost alternative to metals. However, applications that look for efficiency and performance enhancements can benefit tremendously from using PEKK and not worry that its strength would not be sufficient. Since the replacement of metal with PEKK is a one-time expense in most cases, the consequent savings from the improved efficiency of the system would need to be weighed to get a true measure of the total cost savings.

The post Metal vs Pekk: Unveiling the Superiority appeared first on Orthopedic Implants & Instruments Manufacturer/Suppliers- Uteshiya.

Understanding Customization in Implants

Customization in implants means making implants that fit each patient’s specific requirements and features.

It involves planning and making implants specifically shaped for each patient’s body, ensuring they fit and work perfectly.

Customization in implants is different from the old way of doing things, where the same implant sizes and forms are used for everyone.

Instead, it uses cutting-edge technologies like 3D printing and computer models to make implants perfectly suited to each patient’s health and body structure.

This method has many advantages, such as better patient comfort, lower chance of complications, better biocompatibility, and better overall patient outcomes.

Customized implants are especially useful in orthopedics and orthodontic surgery, where accuracy and compatibility with the patient’s unique features are key to success.

Orthopedic Applications

Customized orthopedic implants improve surgery and patient care. Orthopedic implants are customized to meet patients’ anatomical and healthcare demands. Key characteristics of how personalization is impacting orthopedic applications:

Precision and Fit

Customized orthopedic implants offer remarkable precision and fit. These implants are custom-made to fit the patient’s anatomy. Precision decreases problems and improves implant performance.

Improved Functionality

Customized orthopedic implants improve functionality by targeting the patient’s medical condition.

Hip, knee, and bone fracture implants are designed to restore functioning efficiently. This can improve patient mobility and quality of life.

Reduced Pain and Discomfort

Customized implants match the patient’s body, reducing pain and inflammation. Smoother surfaces and greater alignment decrease friction and wear, reducing daily pain.

Faster Recovery

Customized orthopedic implants accelerate healing. The implants reduce tissue disruption during surgery, reducing hospital stays and recovery time.

Personalized Treatment

Each patient’s medical situation is unique. Therefore, customization allows for tailored treatment strategies.

Surgeons can choose the best implant design and materials based on the patient’s needs, age, activity level, and health.

Customized implants boost long-term success. The implant’s perfect fit and reduced risk of problems extend its lifespan, decreasing revision activities.

Enhanced Surgeon Capabilities

Customization improves surgical planning and outcomes for surgeons. These implants improve patient safety by allowing accurate insertion and alignment.

Use of Craniofacial Implants for Restoring Function

The use of craniofacial implants is an amazing example of how medical technology and surgery skills can work together.

Individuals with birth defects, serious injuries, or those who have undergone surgery for illnesses like cancer may require individualized craniofacial implants to restore normal function and look.

Craniofacial surgeons use these implants to fix up the skull and face, from the skull to the jaw, giving their patients a chance at a better quality of life and renewed self-confidence.

Reconstructive surgery has come a long way over the years, and the development of biocompatible materials and the use of innovative medical imaging has greatly improved the accuracy and success rate of craniofacial implant treatments.

Advancements in 3D Printing

Many patients’ only option is to design and print personalized implants. As expected, medical devices and services are expensive and unavailable to all patients.

Medical instruments and products undergo extensive approvals and clinical studies.

Even wealthy patients cannot always locate a suitable implant or organ. Personalized implants can be 3D printed in hours, while conventional implants take days or weeks.

Biomedical engineering uses engineering, computer modeling, and other technology to tackle medical problems.

The main use of 3D printing or additive manufacturing is prosthetics. Customizable and inexpensive prosthetics are improved via 3D Printing.

Prosthetic limbs of any complexity, size, and shape can be made in 24 hours from MRI or CT images.

Massive, patient-specific bone structures and implants with collagenous matrix components and bone integration are promising for musculoskeletal illnesses.

Inkjet printing, laser-induced forward transfer, and other dispensing technologies can print osteogenic cells and hydrogels. This technology could be used for dentistry and osteoporosis treatment.

Benefits for Patients

Customized implants offer a multitude of benefits to patients:
-> Enhanced Comfort
-> Reduced Complications
-> Faster Recovery
-> Long-Term Success

The Surgeon’s Perspective on Customized Implants

Customized implants benefit surgeons in several ways, which are listed below.

-> Surgeons can plan procedures more accurately with implants designed to match the patient’s anatomy.
-> Implants enable precise placement and alignment, reducing the margin for error during surgery.
-> Customization often leads to better patient outcomes, which is professionally rewarding for surgeons.

Exploring Regulatory and Ethical Dimensions in Customized Implants

The growth of customization raises regulatory and ethical concerns.
Regulatory bodies struggle with the need to set high standards to protect patients.
On the other hand, ethical concerns focus on equal access, informed agreement, and the responsible use of new technologies. Finding a balance between new ideas and patient safety is a constant challenge.

Safety

Ensuring the safety and effectiveness of customized implants through rigorous testing and regulatory oversight is paramount.

Accessibility

Efforts are needed to make customized solutions accessible to a broader range of patients, reducing disparities in healthcare.

What is Future Trends in Customized Implants

Accurate planning, improved precision, and the gratification of providing superior outcomes all benefit surgeons.

However, regulatory and ethical considerations become more important in guaranteeing safety and access as the industry develops.

Future developments in high-tech materials, AI, and regenerative medicine are expected to increase the effectiveness of personalized implants, bringing in a hopeful future in medicine where individualized treatment meets the latest technological advances.

Conclusion

Customized implants are becoming increasingly significant in the healthcare equipment business. It is used to make prototypes, small batches, and single objects. Custom parts are also created using this technology. This is significant because it reduces the time and expense required to develop new medical equipment.

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