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Product Launches

Year-End Launches: DJO Nitinol, a Treace Plate, and Stryker Anchors

Q4 is usually about hitting numbers. This one brought real products instead.

Originally published December 29, 2022Arthrex · DJO · Enovis · Stryker · Treace

In this issue


New Nitinol from DJO, Treace Plate, and Stryker Anchors!

ANNOUNCEMENTS

Its that time of year again when cases are stacked up and POs are due. Usually, the back half of the year is all about hitting numbers and less about new product launches. However, in the last two months, we have had several significant new product announcements which gave us the opportunity to send out one more newsletter for the year 2022.

We are very grateful to all our FANs for their continued support. Our distribution list of Foot and Ankle Physicians and Industry members has grown to over 17,000 in 2023. Thank you for sharing and thank you for the feedback!

A big THANK YOU to DEMOBONEfor again sponsoring this week’s newsletter. Check them out for all your foot and ankle training needs.

Please contact us anytime at footandanklenews@gmail.com

Happy New Year!

Big Foot

This Week in FAN

  • New Product Releases: DJO/Enovis | Treace | Stryker
  • Little Guy, Big Idea: BioPoly, LLC
  • FAN Archives
  • PodiatryMeetings.com Calendar of Events
  • AOFAS Meetings Updated Listing

NEW PRODUCT RELEASES

DJO / ENOVIS

We could do an entire newsletter on recent DJO product launches as they are continuing to press the gas on their pipeline of Nitinol Technology. DJO is focusing on its core strengths and leveraging the IP acquired in the Medshape deal to launch some new iterations from both the Dynanail and Dynaclip families.

Let’s take a look...

DynaNail Helix

The Helix offers the same technology found in their flagship DynaNail line, only this time it is available in the form of a 7.0 compression screw. The Helix comes in a headed and headless option and offers 1mm to 4mm (based on length of screw) of active compression in response to bone settling or resorption.

Other companies have tried to create a Nitnol Screw and failed. Innovation in Foot and Ankle is becoming harder and harder, the Helix is not just another screw. DJO has some holes to fill in their bag, but they are positioning themselves to be a force in foot and ankle in the next few years.

Active, Adaptive Healing for Foot & Ankle Fusion

A member of the DynaNail® Family, the DynaNail Helix is a new twist on the nail that is revolutionizing dynamic compression with disruptive NiTiNOL technology. Available in both headed and headless options for procedural and anatomical versatility, Helix’s threads allow for easy insertion like a screw while also providing the dynamic compressive power and stability of a nail.

Dynaclip Quatro and Delta

In addition to nail line extension, two unique Nitinol staple configurations are also being launched and appear to be indication specific:

Quatro – a 4-legged staple plate combo is targeted at CC and TN fusions.

Delta – a 3-legged staple is targeting the MTP fusion market.

Nitinol Staples have become somewhat of a “me too” product across the major players, all of which have had to beef up their offering to compete with the strength of the Dynaclip product. While a Quatro for the CC seems like a no brainer, it will be interesting to see if the market is ready for an MTP staple. If the staple can perform clinically and save time in the OR the product could be a winner.

STAR PSI

The grandaddy of modern TAR is making the jump and has received FDA clearance for PSI.

“We acquired the STAR Ankle just two years ago, and the FDA approval of STAR PSI is just one example of our team’s commitment and investment to taking this best-in-class product to the level it deserves. Surgeons now have leading pre-operative planning and cutting guides, that when paired with years of proven, clinical data, set STAR Ankle up for a brilliant future.”

-Gary Justak, president of Enovis Foot & Ankle

STAR is the 5th PSI system to hit the market following Stryker, Exactech, In2Bones, and Paragon 28. PSI will be available for the STAR in late Q1 2023. With the addition of PSI, a Cross Linked Vitamin E Poly, and a Flat Top Talus, it appears to be better days ahead for the total ankle with the most clinical long term data of any ankle on the market.

TREACE

Speed Plate

Treace received FDA clearance for there Speed Plate, a pegged plate with a contoured design to provide compression, time savings, and smaller incisions. Treace, as we all know, is all in on the bunion game, and proximal bunion correction often times requires a very large incision. Increasing patient satisfaction in anyway while sticking to their core values of correction at the CORA, will potentially help to attract new users.

SpeedPlate is designed for rapid delivery of titanium compression implants as enabling fixation tech with the company’s new Micro-Lapiplasty instrumentation—which allows the Lapiplasty procedure to be performed through 2 cm incisions.

“As with any procedure involving smaller incisions and less tissue dissection, we believe our Micro-Lapiplasty/SpeedPlate offering may translate to even faster patient recovery with less pain and swelling.”

Stryker

Citrefix Anchors

In the unending quest to provide a viable competitor to Arthrex Soft Tissue Anchors, Stryker launches a “suture tak” like anchor for lateral ankle repair. The reversed barbed anchor has a distal eyelet that can be loaded with suture or tape by the surgeon prior to implantation. This eyelet will allow for the creation of bridge constructs as well. The citrogen material is fully bioabsorbable which is an alternative to the many PEEK variations from other companies that have tried to make inroads on Arthrex.

Citrefix is a disposable suture anchor system that features a resorbable biomimetic anchor body. It is made with Citregen, an elastomeric material made from a citrate polymer specially designed to mimic bone chemistry for controlled resorption without chronic inflammation. These unique chemical and mechanical properties are designed to help grafted tissue heal and healthy bone to grow when used in orthopaedic surgical applications. The sterile-packed set includes a cartridge with preloaded implant and eyelet, a drill bit, a drill guide and pre-assembled inserter.

If anyone can make a run to take massive share from Arthrex on the soft tissue side, it is Stryker. While this anchor does not offer game changing technology and does not come loaded makes it less than ideal. However, it does put an anchor in the hands of the Foot and Ankle Sales force and that is a start.

LITTLE GUY, BIG IDEA

Hemi Arthroplasty of the great toe is by no means a new idea. BioPoly, based out of Fort Worth, IN is looking to make another push into creating a viable alternative to fusion of the MTP using its unique patented material that behaves like a synthetic cartilage.

Last year, BioPoly received FDA clearance for their first MTP Hemi and just a few weeks ago received another for the lesser mtp implant. In addition, BioPoly hired Ryan Schlotterback, formerly of Nextrenmity, as CEO to help commercialize these cleared products in the US.

The BioPoly is a patented combination of two well-known orthopaedic materials: “Bio” = hyaluronic acid or HA; “Poly” = Ultrahigh molecular weight polyethylene or UHMWPE.

This unique combination creates a hydrophilic (water-loving) polymer that attracts the lubricating joint fluid to its surface, effectively becoming a “self-lubricated” polymer.

What would it take to make HEMI’s Great Again?

While Cartiva wasn't a hemi, it played in the same space and they had a run that led to an astronomical sale to Wright Medical ultimately ending in epic commercial failure. One of biggest busts in the history of orthopedics: Tony Mandarich, Akili Smith, Ryan Leaf, Tim Couch, and Johnny Manziel all rolled into one.

But doesn’t a hemi of the first MTP make some sense? If the community at large is OK putting in total ankle replacements, shouldn’t we be able to find a way to keep the first MTP mobile? Is it worth a second look? Is BioPoly the answer? Their knee arthroplasty product pipeline which is currently cleared in Europe make them an interesting prospect for a larger player to take a flyer on if the material is a unique enough. It’s a long road ahead, but we will be watching out. Good luck!

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11/23/22

THE TREACE REPORT

9/6/22

AOFAS PREVIEW

8/4/22

NEW PRODUCT LAUNCHES CONTINUE

7/14/22

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PodiatryMeetings.com Calendar

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AOFAS Upcoming Meetings & Courses

Crack the Codes: Practice Management & Coding Virtual Courses

January 11-March 01, 2023

Ask the Experts: Michael Coughlin, MD, and Carroll Jones, MD

January 19, 2023

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January 26-29, 2023

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September 20-23, 2023

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