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Issue Date: June 16, 2022 |
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ANNOUNCEMENTS
No summer slowdown when it comes to new product launches. Paragon 28, Enovis (DJO), Vilex, and Ossio all coming out with new products to kick off an exciting few months leading up to AOFAS this summer in Quebec City.
FAN has teamed up with DEMOBONE to sponsor a new video series on the newsletter. Interested companies can learn more in the newsletter below.
Finally, we will take a look at the May 510k approvals for foot and ankle; the pipeline continues to fill up.
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As always, we are very grateful for all of FANs!
Sincerely,
Big Foot
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This week we have:
- Golden DEMOBONE Award of the Week
- New Product Releases (Paragon 28, Enovis (DJO), Vilex, Ossio)
- Coming Soon - FAN Labs Presented by DEMOBONE
- May 510K Approvals (Medartis, Restor3d, Vilex)
- PodiatryMeetings.com Calendar of Events
- AOFAS Meetings Updated Listing
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A+ posts have CT's, pre-op, intra-op and final X-rays with some rational of the case to boot. This week’s GDA winner offers posts that contain all of those and more. Give him a follow to see a variety of wound, trauma, and elective F&A cases.
Congrats to:
Featured Post of the week is a complex Lis Franc...CHECK IT OUT
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Follow FAN on LinkedIn!
https://www.linkedin.com/company/footandanklenews/
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Paragon28: Monkey Rings
Paragon 28 strikes again, adding to their extensive line-up of foot and ankle solutions.
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The Monkey Rings External Fixation system adds one more product to round out their bag. There is not much left to add in terms of “me too” products for the team out in the Rockies. Adding this to the pin to bar system puts them in a spot that few other foot and ankle companies reside when it comes to a complete foot and ankle portfolio of infix, ex-fix, and TAR.
The haters have come out a little, SEAL president Nic Riccione has made some disparaging comments on LinkedIn about the frame and the company. Honesty and healthy competition is one thing, but this all seems like sour grapes in the eyes of this keyboard warrior. I'm not sure the best way to go about selling you frame company is by bashing the competition. Paragon 28, love them or hate them, has made a massive push to bring an expansive product portfolio to market and shows no signs of slowing down. They are positioning themselves for a massive exit if things fall into place for them.
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Enovis (DJO): Arsenal Ankle Fracture System |
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Say it 3 times….Enovis, Enovis, Enovis. Enovis (DJO) put themselves on the foot and ankle map last year by purchasing Medshape, Triliant and Star and have begun their launch with their first of an expected five product launches in 2022. |
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The Arsenal Ankle Fracture system is a complete system offering 37 plates, 5 screw sizes, 60 degree variable angle locking, and a variety of instruments including an expansive set of reduction clamps - all in one tray. A unique feature of the system is a medial tension band plate which puts a “modernized spin on the proven AO technique of tension band wiring.”
Here is what President of Foot and Ankle at Enovis, Gary Justak, had to say:
“Not only are we going to push the envelope in acquiring great products but internal innovation will be the foundation for our path to market leading growth. Our teams have been incredibly hard at work to continue to innovate disruptive technologies that drive efficiencies and improve outcomes and we are extremely excited to launch Arsenal Ankle to the market. With over 37 plates and countless options, this represents the most complete and comprehensive system on the market.”
Enovis is ready to play in the foot and ankle market. They have put together a management team of experienced foot and ankle veterans and have some proven technology platforms to build upon, especially when it comes to Nitinol. Their distribution sales force is growing rapidly. Exciting times ahead for Enovis.
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Vilex: Dynex Speed Struts
DYNEX Speed Struts allow for up to +/- 50 degrees of multiplanar angulation as well as compression and distraction.
The Speed Lock allows for quickly locking in correction and length with a simple push and twist Speed Lock, instead of the gradual correction collar featured in DYNEX Telescopic Struts.
Gradual compression and distraction can also be achieved with Speed Struts by turning the Adjustment Knob, in .25mm increments.
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Vilex continues to add to their portfolio making them a new player in the independent foot and ankle game. As the line continues to build, higher end distribution partners could follow. The Hinterman H3 is still a big unknown in the US market and in order to catch on, Vilex will need to get some names behind the implant. PSI would also help as it is now an industry standard. Product launches keep companies relevant and Vilex seems committed to that. Focusing on the bigger dollar cases like Charcot and Ankle Replacement is a good start. |
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Ossio - 4.75 Suture Anchors
Ossio adds to their unique line of fiber screws with a logical next step…suture anchors. While at first glance, these may not seem that novel, however the make-up of the anchor is what makes them special. Ossio is a material company, their secret sauce is Ossio Fiber, a resorbable matrix engineered for rapid bone in-growth, regeneration, and replacement.
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Anyone can now make a titanium or peek suture anchor. Both of those materials come with draw backs when it comes to revisions, and they have no added value for the VAT committees when it comes to approvals in large IDN’s. A fully resorbable anchor is a unique selling feature for Ossio which will help to attract stronger independent distribution teams, boost sales, and potentially help them sell to a company with the resources to significantly expand the offering of the anchor line.
Anchors are a surgery center product, if the pricing is right and the product performs this could be the start of something big for the team at Ossio. The product is due to launch at the end of the month, see the product brochure ink below.
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FAN LABS presented by DEMOBONE
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Attention Device Sales, Marketing, and MedEd Teams!
FAN is excited to bring product introduction and medical education to a new level by inviting companies to produce an original video of an existing or new product innovation that they would like to showcase to our readers.
Foot and Ankle News has teamed up with DEMOBONE, a distributor of high-quality, cost-effective bone models. DEMOBONE will provide participating companies a demonstration model to use to create a unique video in the spirit of FAN. If the content produced is solid, FAN will present it to our audience on the Newsetter, Website, Instagram, and LinkedIn. There will be no cost to participate.
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Thank you to DEMOBONE, our first official sponsor. If you are looking for an alternative to Sawbones, DEMOBONE is your source for custom or stock bone models. Many foot and ankle items are ready to ship today.
Looking to save on your training models?
Enter your current Sawbones part numbers or Upload a previous Sawbones invoice and receive an email quote within 24 hours showing your cost savings.
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510K APPROVALS - MAY 2022 |
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Spoiler alert! Each month the FDA releases a list of all medical devices cleared (286 this month) through the CDRH Premarket Notification process [510(K)]. This month there were some notable approvals for devices in the foot and ankle space from some of the independent players.
Without further ado, here are the 510k Clearances for May 2022:
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Nextremity, now a part of Medartis, gets its first approval since the acquisition for a calc slide system. The system appears to have a jig that can assist in the displacement of the osteotomy. With focus shifting to MIS, I wonder if this system will offer a way to make those cuts and pin throws more reproducible? We will have to wait and see. |
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In addition to the CalcShift, Medartis announced their first clinical use of their Lapidus Cut Guide, due to be released later this year. The cut guide is a single use, implant agnostic guide.
The single-use Lapidus Cut Guide system is an instrumentation-only system designed to provide an anatomically intuitive resection of the first tarsometatarsal joint (TMT) in preparation for a Lapidus procedure which aims to surgically treat a bunion deformity caused by TMT joint hypermobility. The versatile cut guide allows the surgeon to resect both sides of the joint, potentially helping reduce the risk of unnecessary shortening of the first metatarsal while providing an unconstrained angle correction. The flexibility of the design allows surgeons to tailor the resection to meet the unique requirements of the patient’s anatomy.
Medartis is starting to see the fruits of their $40 million dollar purchase of Nextremity. It sounds like they will have 3 or 4 new products launched by the end of 2022. Look out for Medartis moving forward!
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Restor3d, the new go-to company for Foot and Ankle 3D customs, gets approval for a 1st mpj hemi implant. Don’t call it a comeback, the hemi implant has been here for years. In April, Restor3d raised a $23 million dollar round which will help to bolster future innovation in the 3D space and other implant systems it appears. Restor3d is being ran by co-founders Andrew Miller and Ken Gall, who previously ran and sold MedShape to Enovis (DJO).
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Vilex, showing for the second time in this newsletter, gets approval for a mini frag system to help round out their current plating line. Congrats to the Vilex team, continuing to make it happen down in Tennessee.
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PodiatryMeetings.com Calendar
Looking for a meeting?
This resource has an extensive amount of information for meeting opportunities where you can earn your required continuing education credits.
Click below to access the extensive meeting calendar.
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AOFAS Upcoming Meetings & Courses |
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June 29, 2022
July 7-9, 2022
July 14, 2022
July 16, 2022
July 18, 2022
July 21, 2022
July 27, 2022
August 13, 2022
September 14-17, 2022
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About Foot and Ankle News & Contact Information
Foot and Ankle News is curated roundup of the most impactful news for Foot and Ankle Doctors, Rep’s, and Exec’s delivered weekly directly to your inbox.
- Breaking News
- Device Technology
- Journal Reviews
- Upcoming Events
- Practice Advice
All of our posts from our weekly email newsletter can be found at www.footandanklenews.com. Our newsletter goes out to over 12,000 foot and ankle surgeons and industry professionals across the country. The articles are created by a group of volunteers and freelance industry insiders. If you you would like to contact us or have an article or topic you would like to share, please submit it to: footandanklenews@gmail.com
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