Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing Systemhttps://surfacehippy.info/exactech-announces-fda-breakthrough-device-designation-for-jointmedicas-polymotion-hip-resurfacing-system (https://surfacehippy.info/exactech-announces-fda-breakthrough-device-designation-for-jointmedicas-polymotion-hip-resurfacing-system/)
GAINESVILLE, FLA. (May 17, 2022) â€" Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System.
Exactech, a minority shareholder of JointMedica Limited, is collaborating with the United Kingdom-based orthopaedic device designer and manufacturer to deliver the next generation of hip resurfacing to the global market, and holds exclusive global distribution rights to the product.
“This designation by the FDA is a validation of our core belief at JointMedicaâ€"that our hip resurfacing device addresses an acute unmet need of relatively younger, active hip arthritis patients,†said Terence Smith, Managing Director of JointMedica.
According to Exactech Chief Strategy Officer, Sharat Kusuma, MD, “We are thrilled that PolyMotion and JointMedica have been recognized as one of only 71 orthopaedic devices that have received breakthrough designation since the inception of this program. We aspire to accelerate Polymotion hip resurfacing development and help more patients get back to all the activities they love.â€
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
“…The introduction of metal-on-vitamin E crosslinked polyethylene hip resurfacing would be most welcomed by me as a practicing surgeon and well-received by my patient community…â€
Craig J. Della Valle, MDMidwest Orthopaedics at Rush
“Hip Resurfacing remains an excellent choice for young, active patients, who will inevitably place a higher demand on their hip reconstruction. The introduction of metal-on-vitamin E crosslinked polyethylene hip resurfacing would be most welcomed by me as a practicing surgeon and well-received by my patient community,†said Craig J. Della Valle, MD, of Midwest Orthopaedics at Rush in Chicago, Illinois.
Dr. Della Valle is joined by colleague Scott Marwin, MD, of NYU Langone Orthopedic Hospital, in an advisory role in submitting for the breakthrough designation.
“Through this deep collaboration Exactech and JointMedica are well positioned to bring the Polymotion Hip Resurfacing System to the global market. Partnering with surgeons at the early stages of development has always served a fundamental role in our success,†said Jeff Binder, CEO and Chairman of the Board of Exactech. “Polymotion will complement Exactech’s Alteon® hip arthroplasty portfolio, comprised of substantial advancements in design and materials to time-tested solutions.â€
With more than three decades of experience using hard-on-hard articulations in hip resurfacing, Derek McMinn MD, FRCS, and Ronan Treacy, MD, FRCS, designed the Polymotion Hip Resurfacing System to leverage the clinically successful design principles of their previous hip resurfacing devices, now with advanced polyethylene and titanium manufacturing technology. The Polymotion hip offers the biomechanical benefits of hip resurfacing but eliminates metal-on-metal articulating surfaces.
About JointMedica
JointMedica is an orthopaedic design and development “Think Tank,†intending to advance and disseminate new concepts which result in the creation of innovative orthopaedic implants. Our objective is to form close relationships with key orthopaedic surgeons, empowering the creation of products that are highly innovative while at the same time meeting the heightened expectations of patients along with the stringent quality and safety standards that apply to modern orthopaedic implants.
Visit www.jointmedica.com (http://www.jointmedica.com)
Contact cs@jointmedica.com
About Exactech
Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com (http://www.exac.com) for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.
Polymotion® & POLYMOTION®. Registered trademarks of JointMedica
Alteon®. Registered trademark of Exactech
Press Release
Media contact
Morgan Lee
Exactech Marketing Communications
Morgan.lee@exac.com
Thanks for posting this.
I do wonder, though, how long the "Vitamin E Crosslinked Polyethylene" surface will last.
Time will tell.
Yes, until it has been used for awhile, there won't be any studies.
This is very interesting. Looks like the same Polymotion device Mr. McMinn was working on years ago:
https://youtu.be/q5_1s87VsBE?t=737
Hi Pat and all been a while. This is the way to go as I ended up with metallosis big time but I loved the Resurfacing hips as long as they lasted. About only 10% of the population will handle metal the other 90% wont pretty much from what I read. Saying that the ceramic (alumina oxide I have is even worse and had them changed to Poly of ceramic) THR. Still not out of the woods yet Pat THR in young males the failure rate is over 50% in which I have failed devices now and are suffering again. The Modular junction of the THR has issues that they are aware of for decades and done nothing about it engineering wise. But the best options still are Poly on metal. Surgeons are not engineers nor do the sample the THR"s in the own bodies for failure and fixes. There are modular issues with offset heads, Large heads, over produced torque for the THR head, Taper matching, No procedure or polices or best practice world wide for modular system heads. I reckon its pretty much any surgeons game. I have found a massive amount of issues with THR that could have been solved and yet they don't seem to do that Collaboratory. McMinn will have his own device, Dr Pritchett has his own device why don't they all get together and make a super device out of all of this? I suppose its money driven and market driven. I had 2 level disc replacement Germany 2013 almost 10 years ago when 9 surgeons from different countries got together and designed spinal Kinetic Disc. Never had anu issues there after.
But they don't do that with hips?
Good luck with the resurfacing and the Metal on Poly will be the best from my failure, the question is it will take a while for the product to become reliable when already Dr Pritchett has been doing this device and a Dr Beagle for along time now so its proven.
Best wishes Karlos
If I'm not mistaken Dr. Pritchett and Mc Minn have done some work/collaboration together. I seem to recall there being a professional cross consultancy in developing the Synovo device that utilizes a cross link poly acetabulum cup but don't recall the specifics- probably some mention/history on Dr. Pritchett's comprehensive website for those interested.
When Dr. Pritchett did my bilateral surgeries in 2018- will be 4 years in a couple of weeks- I left the device decision to him with my expressed preference for the Synovo, which is what he decided to use. I would have accepted a MOM if it had been his choice but the metal ion issue was a concern and I was and continue to be overwhelmingly grateful and pleased with the surgeries and the prosthetics. Dr. Pritchett has expressed his confidence in the advancements the cross poly brought to HR surgery and I have the greatest confidence in his opinion.
Every once in a while I'll think how weird it is to have prosthetic hips but never based on any physical symptom, just from a psychological perspective. It has been 4 great pain free years of almost complete function and return to normal and strenuous activity and the only limitations I really experience are more age related [67] or a deficit in specific muscular training- for example, there is not as much quick muscle impetus in a sprint start or kick but then I'm not 19 any more either. My ROM is excellent although lateral extensions have some limitation and my results have been fortunately life saving.
Dr. Pritchett was recently listed as one of Seattle's Top Docs in a local well read periodical. My personal opinion is that geographic recognition is far too limited. He also did a friend's THR this past Spring- she's 77 and doing well. I hope to sail these Synovo Hips into the sunset. Best regards, all.