FH Ortho, maker of thoughtfully designed orthopedic devices and instruments for surgeons around the world, today announced it has received approval from The U.S. Food and Drug Administration (FDA) to market the CALCAnail® System to treat calcaneus (heel) fractures and subtalar arthrodesis (rear foot fusion surgery) in the United States. The CALCAnail System and technique have been used in Europe since August 2011.
The CALCAnail Orthopedic Arthrodesis Nail is indicated for subtalar arthrodesis in the treatment of patients with:
- Comminuted fractures of the calcaneus
- Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae
- Osteoarthritis of the posterior subtalar joint, or
- Valgus flatfoot deformities
“The CALCAnail System allows surgeons to employ an innovative reduction technique that reduces surgical trauma and the risk of complications,” said Jim Hook, Managing Director of FH Ortho’s U.S. operations. “Surgeons use a through-the-heel approach, with a hollow reamer to tunnel into the calcaneus, making it possible to correct calcaneal tuberosity displacements and obtain good reduction of the joint for intra-articular fractures that are composed of large fragments.”
Harnessing a minimally-invasive, closed technique that uses a nail and cannulated screws, the CALCAnail System is indicated for repair of displaced intra-articular fractures of the calcaneus, but also subtalar arthrodesis following intra-articular fracture of the calcaneus (subtalar osteoarthritis and malunion) or degeneration of the subtalar joint.
“In laymen’s terms, there are 120,000 rear foot/heel fractures a year in the United States, about half of which require surgery,” points out Hook. “With this approval, surgeons have another option for giving their patients a minimally invasive repair that holds their heel together so it can heal correctly.”
Week of June 8th
Bunionettes Part II
Michael J. Coughliln, MD
Wednesday, June 10, 2015
8:00 pm EDT
Thursday, June 11, 2015
8:30 pm EDT
Additional June Webinars
The Management of Valgus Ankle Deformity with Replacement
Mark Myerson, MD
Thursday, June 18, 2015
8:00 pm EDT
Arthrex Acute Lisfranc and Medial Column Fusion Plating Options
Thomas Harris, MD & Nicholas Abidi, MD
Tuesday, June 23, 2015
9:00 pm EDT
Each month we will provide a preview of the print version of Foot and Ankle International. All articles will be linked to the abstract. Any article that has hardware or instrument specific techniques from an orthopedic company will be designated with a picture and/or description linked to the product(s) in the article.
Keep an eye out for these 4 products represented in articles this month:
- Hintegra Ankle by Integra
- Mobility Ankle by DePuy Synthes
- Ziptight Syndesmosis by Biomet
- Achillion by Integra
Low Incidence of Symptomatic Thromboembolic Events After Total Ankle Arthroplasty Without Routine Use of Chemoprophylaxis
• Phillip H. Horne, Jason M. Jennings, James K. DeOrio, Mark E. Easley, James A. Nunley, Samuel B. Adams
Reliability and Validity of 6 Measures of Pain, Function, and Disability for Ankle Arthroplasty and Arthrodesis
• Ellie Pinsker, Taucha Inrig, Timothy R. Daniels, Kelly Warmington, Dorcas E. Beaton
Infected Total Ankle Arthroplasty: Risk Factors and Treatment Options
• Daniel Patton, Nathan Kiewiet, Michael Brage
Single-Photon-Emission Computed Tomography in Painful Total Ankle Replacements
• Lyndon W. Mason, James Wyatt, Clifford Butcher, Hülya Wieshmann, and Andrew P. Molloy
Fracture-Dislocations Demonstrate Poorer Postoperative Functional Outcomes Among Pronation External Rotation IV Ankle Fractures
• Stephen J. Warner, Patrick C. Schottel, Richard M. Hinds, David L. Helfet, and Dean G. Lorich
Operative Versus Nonoperative Treatment of Geriatric Ankle Fractures: A Medicare Part A Claims Database Analysis
• Jason T. Bariteau, Raymond Y. Hsu, Vincent Mor, Yoojin Lee, Christopher W. DiGiovanni, and Roman Hayda
Comparison of the Outcomes Between Two 3-Component Total Ankle Implants
•Hong-Geun Jung, Min-Ho Shin, Sang-Hun Lee, Joon-Sang Eom, and Dong-Oh Lee
Why Do Lesser Toes Deviate Laterally in Hallux Valgus? A Radiographic Study
• Li-Yi Roan, Yasuhito Tanaka, Akira Taniguchi, Kiyonori Tomiwa, Tsukasa Kumai, and Yuh-Min Cheng
Influence of Fragment Size and Postoperative Joint Congruency on Long-Term Outcome of Posterior Malleolar Fractures
• Cornelis Christiaan Drijfhout van Hooff, Samuel Marinus Verhage, and Jochem Maarten Hoogendoorn
Maintenance of Reduction With Suture Button Fixation Devices for Ankle Syndesmosis Repair
• Kyle S. Peterson, W. Drew Chapman, Christopher F. Hyer, and Gregory C. Berlet
Complications of Minimally Invasive Calcaneal Osteotomy Versus Open Osteotomy
• Adrian R. Kendal, Ali Khalid, Tom Ball, Mark Rogers, Paul Cooke, Robert Sharp
Evaluation of Absorbable and Nonabsorbable Sutures for Repair of Achilles Tendon Rupture With a Suture-Guiding Device
• Baris Kocaoglu, Tekin Kerem Ulku, Arel Gereli, Mustafa Karahan, Metin Turkmen
Proximal Supination Osteotomy of the First Metatarsal for Hallux Valgus
• Toshito Yasuda, Ryuzo Okuda, Tsuyoshi Jotoku, Hiroaki Shima, Takashi Hida, and Masashi Neo
Lateral Column Lengthening Corrects Hindfoot Valgus in a Cadaveric Flatfoot Model
• Josh R. Baxter, Constantine A. Demetracopoulos, Marcelo Pires Prado, Theerawoot Tharmviboonsri, and Jonathan T. Deland
An Attachment-Based Description of the Medial Collateral and Spring Ligament Complexes
• Barrett P. Cromeens, Claire A. Kirchhoff, Rita M. Patterson, Travis Motley, Donald Stewart, Cara Fisher, and Rustin E. Reeves
Plantar Loading Forces While Walking in a Below-Knee Cast With an Attached Loadbearing Frame
• James Theo Berwin, Thomas Michael Weston Burton, Jonathan Taylor, Alison H. McGregor, and Andy Roche
Safe Zone for Placement of Talar Screws When Fusing the Ankle With an Anterior Plating System
• Andrew Haskell, Russell Dedini, and Monara Dini
Will it Work?
Who knows, but I have a feeling the boys down in Texas have a good chance of selling a bunch of these things. In a world of “me too” products, BME is going after the massive bunion market by introducing a product unlike any other. The current options for treating bunions (k-wires, screws, tightrope, plates) all have some level of fiddle factor, this three pronged staple seems like it has a chance to simplify the procedure and significantly reduce OR time. To be clear, I have not yet seen the product demoed or in a live case, but assuming it works half way decent the purchase price of BME just went up.
DESIGN and TECHNIQUE
The Speed Triad is a three pronged nitinol compression device designed for fixation of distal chevron osteotomies of the first met. The Speed Triad Technique guides shows two options for implantation: dorsal and medial.
A Data Sheet found on the Triad product page of BME’s website shows:
TRIAD PERFORMANCE HIGHLIGHTS
Compared to single and double screw fixation of distal metatarsal osteotomies, Speed Triad provides:
• Greater compression.
• More contact area at the fusion interface.
• Higher peak strength.
• Higher construct strength after repetitive loading.*
Sonoma Orthopedics, known for their novel clavicle nailing system, has recently entered the the ankle fracture market with the FibuLock Nail. The following is an excerpt from there press release:
The FibuLock™ Nail is designed to treat the same fractures as plates as well as provide for anatomic ligament stabilization, but with a much less-invasive approach. The device is implanted into the fibula through a small incision less than an inch long. Reduced incisions are generally recognized to be less susceptible to infection. After the surgeon aligns the broken bones, the nail is inserted within the bone canals. Proprietary FibuLock™ anchors are then activated, stabilizing the fracture for healing. Additionally, the device is anticipated to lessen the incidence of secondary removal surgeries because FibuLockTM is inside the bone which does not create the discomfort associated with plates.
Rick Epstein, CEO of Sonoma states, “Nails have already replaced plates as the gold standard for repairing fractures in the femur and tibia (thigh and shin bones) because nails are less-invasive and deliver fewer post-operative complications with faster rehabilitation. However, developing a nail for the fibula is difficult due to its small size and unique geometry. Until the FibuLock™, there wasn’t a device that could deliver the stability, versatility and effectiveness of plates. Now, our technology will allow surgeons to bring the advantages of nailing to ankle fracture patients.”
Sonoma will be competing with for market share in this niche space against a sole competitor in Acumed who also offers a Fibula Rod System.
Will there be a paradigm shift in the way ankle fractures are treated? Probably not. However, with ankle fractures being one of the most common fractures of the body, even a small percentage of the market could lead to some big dollars for the team at Sonoma.
If you are a surgeon who treats ankle fractures and you have an opinion on fibular nailing, hit us up at firstname.lastname@example.org or on twitter at @footankleblog.
With the Zimmer Biomet merger weeks, if not days away, it’s time we look at this new entrant in the foot and ankle market. With neither company holding any significant market share you have to believe that they will be making a push to take their piece of the pie. Let’s take a look at what they have:
The TM Lateral Ankle will have its pockets of users, but it will never be a market leader. We will have to see the anterior ankle before we can fully lock in this grade.
- Zimmer TM
- Biomet – anterior low profile ankle coming 4th quarter-ish of 2015???
- The Journal of Foot and Ankle Surgery
- Foot and Ankle International
- Journal of Arthroplasty
Sign up free @ www.footinnovate.com.
CLINICAL WEBCAST: BUNIONETTES PART I WITH MICHAEL J. COUGHLIN, MD
May 26, 2015 8:00 PM – 9:00 PM
Eastern Standard Time
Dr. Coughlin will be offering a two part series on Bunionettes. Part II of this series will take place on June 10. You must register for both events to participate.
Per the FTC, the merger between Wright Medical and Tornier cannot happen until the Salto Talaris Total Ankle is divested from the new companies portfolio. What looked like a great pick up for the Wright Medical extremity reps turns out to be a total bust in terms of snagging some easy ankle business. Now the question becomes who will buy it and more importantly who can Wright sell it to without shooting themselves in the foot by strengthening a competitor. This is no easy task and the management team at Wright is going to have to pull the trigger soon.
So where is it going to land? Let’s look at the contenders:
to keep you informed on the happenings in the world of foot and ankle. We are sorry for that but…We’re baaaackk!!!!
After a short 18 month sabbatical, Foot and Ankle Blog is ready to churn out some more content for the sorry shleps like us who actually care about this stuff.
We look forward to relaying industry info, new product news, academic reviews and much more. If you have anything you would like to talk about, contact us at email@example.com.