Arthrex’s Post

#Arthrex is proud to announce that our stemless Eclipse™ humeral system has achieved a prestigious “7A” rating from the independent Orthopaedic Data Evaluation Panel (ODEP). ODEP objectively ranks the performances of medical devices and implants to provide surgeons with an evaluation of the safety, longevity, quality, and performance of orthopedic implants based on documented data from reliable registries and clinical publications.* These independent ratings help surgeons to make educated and informative decisions on implant selections for their patients.* The Eclipse system’s ranking of “7A” represents over 7 years of data collected from a high number of patient cohorts, and the “A” rating is the ODEP’s highest evidence strength grade based on the assessment of patient outcomes and implant performance data.* Learn more about the Eclipse stemless implant clinical data: https://lnkd.in/dHaRyExT DOC1-000088-en-US/eclipse-stemless-implant-scientific-update-a-review-of-modern-techniques #Innovation #MedicalEducation #Eclipse #Arthroplasty *Orthopaedic Data Evaluation Panel - ODEP, https://lnkd.in/d7QNGBXU

#Arthrex is proud to announce that our stemless Eclipse™ humeral system has achieved a prestigious “7A” rating from the independent Orthopaedic Data Evaluation Panel (ODEP). ODEP objectively ranks the performances of medical devices and implants to provide surgeons with an evaluation of the safety, longevity, quality, and performance of orthopedic implants based on documented data from reliable registries and clinical publications.* These independent ratings help surgeons to make educated and informative decisions on implant selections for their patients.* The Eclipse system’s ranking of “7A” represents over 7 years of data collected from a high number of patient cohorts, and the “A” rating is the ODEP’s highest evidence strength grade based on the assessment of patient outcomes and implant performance data.* Learn more about the Eclipse stemless implant clinical data: https://lnkd.in/dHaRyExT DOC1-000088-en-US/eclipse-stemless-implant-scientific-update-a-review-of-modern-techniques #Innovation #MedicalEducation #Eclipse #Arthroplasty *Orthopaedic Data Evaluation Panel - ODEP, https://lnkd.in/d7QNGBXU

At the Orthopaedica Belgica congress, the focus on personalized orthopedic care led to insightful conversations and highlighted significant progress in orthopedics. ➡️ 3D planning and patient-specific instruments are here to stay. The shift of complex decision-making outside the OR is a game-changer, reducing stress during surgeries. For challenging cases, it has the potential to improve predictability and outcomes for patients. ➡️ The ability to customize surgical procedures to individual needs is at the core of 3D innovation. ➡️ Balancing cost with reimbursement remains a challenge in healthcare innovation. Ensuring reimbursement is available for these patients is crucial to improving their quality of life. This congress was a reminder of the incredible potential within our reach. By continuing to collaborate across disciplines—uniting engineers, surgeons, and regulatory bodies—we can overcome the hurdles and move a step further toward mass personalization. #Orthopaedics #Innovation #3DPlanning #medicaldevices #custom

FDA Cleared vs. FDA Approved: Know the Difference! As a conscientious attendee of the ESSKA - European Society of Sports Traumatology, Knee Surgery & Arthroscopy Congress in Milan, I navigated the exhibition area dedicated to our Pharma Industry Partners to stay abreast of the latest advancements in orthopaedic surgery equipment. Among the displays, one particular stand drew my attention with their cutting-edge wireless arthroscopy shaver. The interaction with the medical representative went smoothly, and my curiosity was genuinely piqued—until I inquired whether the product was FDA approved. The response was that it had been "FDA cleared." When I clarified that FDA cleared is not the same as FDA approved, the representative confidently asserted, "FDA doesn't like to use words like 'approved,'" insisting there was no difference between the two. This brazen confidence left me stunned, but it also sparked a realization. Such subtle language nuances often go unnoticed by us Europeans, putting us at risk of misinformation. So, let's demystify what "FDA cleared" and "FDA approved" really mean: FDA Approved: This indicates that the FDA has confirmed the benefits of a product outweigh the known risks for its intended use. Manufacturers must submit extensive data, including clinical testing results, through a premarket approval (PMA) application. FDA Cleared: This status is granted when a manufacturer demonstrates their product is substantially equivalent to another legally marketed device. Often, this existing device (or predicate) may even have been previously recalled for safety concerns, yet it still serves as a basis for clearance. Imagine a scenario in a prestigious center looking to hire an Orthopaedic Surgeon. The top criterion is to confirm the candidate’s human status—perhaps cheekily suggested by a DNA test showing 99% similarity with the previous surgeon. If we used the FDA’s logic of substantial equivalence, we might end up with a rather unexpected new surgeon—a chimpanzee in scrubs! Consider the implications of such an absurdly "cleared" candidate. By understanding these distinctions, we can better navigate the complex landscape of medical device approvals and avoid falling for misleading claims, no matter how confidently they are presented. #FDAcleared #FDAapproved #MedicalDevices #PatientSafety #OrthopaedicSurgery #HealthcareInnovation #MedicalMisconceptions #InformedDecisionMaking

Three-year contracts are becoming a successful practice at the MPU. This time, on behalf of the Ministry of health of Ukraine we have signed three-year contracts for the purchase of 35 types of medical devices for orthopedic, traumatology, and neurosurgical operations. Now we can be certain that medical devices will be available in hospitals for the next three years. The total value of the contracts – 750 million UAH. The first deliveries are expected by the end of autumn. In particular, the following medical devices are included: 🔹Knee and hip endoprostheses of both cemented and uncemented types for primary endoprosthesis 🔸Hip and knee joints for revision endoprosthesis 🔹Implants and tools for correcting complex scoliotic spine deformities 🔸Kirschner wire 🔹Intramedullary fixation (rods) 🔸Titanium meshes for cranioplasty etc. The procurement was carried out with significant savings. For instance, the expected cost for 286,134 units of Kirschner wires was 20.3 million UAH. This is a surgical instrument used to treat bone fractures. During the MPU auction, the price dropped to 6.5 million UAH, saving over 13 million UAH – https://bit.ly/4gQKhin. Additionally, the cost for various types of plates was reduced to 44.9 million UAH, saving over 150 million UAH – https://bit.ly/4etghYr. #medical #procurement #contracts #devices #orthopedic #traumatology #neurosurgical_operations #hospitals

At ConforMIS, we strive to provide our surgeon partners with the most advanced orthopedic solutions. According to recent clinical studies, our customized products consistently outperform off-the-shelf implants. As generic, off-the-shelf implants are manufactured in limited, pre-determined sizes, they do not always adequately fit the patient anatomy. Patient-specific implants are designed to fit each individual. This study of 24,042 knees suggests that greater adoption of patient-specific procedures could potentially reduce the overall number of soft tissue releases and medical resections. Read the full study here: https://buff.ly/486bzM7 (Meier, M., Zingde, S., Steinert, A., Kurtz, W., Koeck, F., & Beckmann, J. (2019). What is the possible impact of high variability of distal femoral geometry on TKA? A CT data analysis of 24,042 knees. Clinical Orthopaedics and Related Research®, 477(3), 561-570.)

📢 #September Paper Express We're thrilled to share one latest research article📃"Reliability of pre-resection ligament tension assessment in imageless robotic assisted total knee replacement" by ✍Michael Tim Yun Ong et al. 🔎Explore how robotic technology revolutionizes ligament tension assessment in total knee replacements, ensuring improved surgical outcomes and patient satisfaction. https://lnkd.in/g9UuCexe 🔑 Key Findings: ✅ Excellent inter-rater reliability in crucial assessments. ✅ Robotic assistance provides a reliable solution for precise ligament tension evaluation. ✅ Advancing orthopedic practices with technology-driven innovations. #Arthroplasty #KneeSurgery #Orthpedics #TKA #RoboticSurgery #Ligament

Surgeons, we're curious: When do you choose bone grafting, and are personalized implants on your radar for cases with significant glenoid vault loss? 🤔 Join us at the Antwerp Shoulder and Elbow Arthroplasty Course to dive deeper into this discussion. We can't wait to hear your insights at our booth! 📆 April 18 – 19 📍 Elisabeth Congress Center Antwerp 👨🏼💼 Frederick Vanderlinden , Jolien S. , Robbe Asselberghs #shouldersurgery #orthopaedics #medicaldevices #personalcare #healthcare

Transforming MPFL Repair: Adopting the Single Incision Technique Enhanced by Reinforced Bio-Inductive Implants for Optimal Strength and Accelerated Recovery. This pioneering approach integrates precise surgical techniques with advanced bio-composite technology, improving ligament repair outcomes, minimizing complications, and expediting the return to full activity for patients experiencing recurrent patella dislocations. For an in-depth understanding, please refer to the full article available in the Journal of Orthopaedic Experience & Innovation Authors: Austin Wetzler, Sean McMillan, Aakash M. Patel, William Taylor, and Merrick Wetzler

Inion CompressOn Headless Screw is the future in orthopedic world