Month: March 2018

Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance

Gainesville, Fla. (March 19, 2018) – Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. These liners are designed to work in conjunction with the Novation® Crown Cup® Acetabular System including InteGrip® printed, 3-D porous material.

The advanced bearing material in the new XLE liners is designed for low wear and contains vitamin E. Oxidation in-vivo can contribute to polyethylene degradation in orthopaedic implant polyethylene. Vitamin E, a natural antioxidant, is blended into the raw material of Novation XLE liners to mitigate oxidative effects both before and after implantation.

This product complements Exactech’s Hip product family, which also includes the Alteon® HA Femoral Stem, Tapered Wedge Femoral Stem, Neck Preserving Stem and Monobloc Revision Stem.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at https://staging.exac.com.

Media Contact

Priscilla Bennett
Vice President, Corporate & Marketing Communication
(352) 377-1140
media@exac.com

What are the Benefits of CAOS for Shoulder Replacement?

Ari R Youderian, MD

Read complete study: Benefit of intraoperative navigation on glenoid component positioning during total shoulder arthroplasty

I have now performed my first 40 shoulder replacement cases with computer assisted orthopaedic surgery (CAOS).  As an early adopter of this technology, the meta-analysis by Sadoghi et al, “Benefit of intraoperative navigation on glenoid component positioning during total shoulder arthroplasty” was very intriguing to me.  The authors reveal seven cases of comparative studies between CAOS and standard shoulder replacement.  The biggest finding was a combined 6 degree difference in glenoid version, but they found limited data and differences in inclination or other parameters.  The study emphasizes the point that navigation will continue to demonstrate improved accuracy in postoperative position, but we are only scratching the surface with the power of this technology.  As a fairly high volume shoulder surgeon, even I can easily see a difference in glenoid placement, angulation and screw positions as I compare my postoperative radiographs from my navigated cases to my pre-navigation cases.

The good news is that CAOS for shoulder replacement is finally here.  This is not the same as patient specific instrumentation; it’s a step further.  The newest CAOS system allows for robust planning, continuous feedback to the surgeon throughout the case and the ability to deviate from the plan but still always know where you are.  The authors make a great point about the added benefit of both accuracy and reliability.  Not only do these systems allow you to place a glenoid within 1mm and degree of your plan, but they will commonly decrease the margin of error.  This is a common theme of eliminating outliers, seen with the knee CAOS systems, especially for those who perform these cases less often.

During my fellowship, CAOS was not available.  My mentor was finishing up his work on the first patient specific navigation system, and we used a robust 3-D planning tool.  I quickly bridged the gap between the standard radiograph and 2-dimensional planning seen in residency to the eye-opening concepts of 3-D, including planning and implementation of glenoid sizing, seating, use of augmented implants, finding the best bone for fixation and bone graft planning in severe deformity cases.

Preoperative planning software has allowed me to more accurately choose glenoid sizes and augmentation, as well as estimate the patient’s native glenoid position.

Since that time, these concepts have permeated in each case that I carefully planned, but I did not have the tools to translate them to the operating room.  Previous studies have demonstrated that the use of preoperative planning software alone adds to the accuracy of glenoid placement.  Preoperative planning software has allowed me to more accurately choose glenoid sizes and augmentation, as well as estimate the patient’s native glenoid position.  In addition, augmented glenoids are much easier to place with CAOS, as the guessing of how much bone to remove and at what angle to start are removed from the equation.  The majority of my decision making is now performed prior to the start of the surgery, and it is then executed more promptly and efficiently during the surgery.

One important clarification that this study does not address is the difference between cadaver studies, virtual studies and in vivo studies.

(more…)

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Exactech Receives 510(k) Clearance for Equinoxe® Stemless Shoulder

Gainesville, Fla. (March 12, 2018) – Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today it has received clearance from the U.S. Food and Drug Administration to market the Equinoxe® Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe® Shoulder System. The Stemless Shoulder is the latest addition to the company’s extremities product line.

“Our world-class design team and engineers deserve a lot of praise for this new product, and in particular, for an efficient product development process. Their ingenuity, coupled with their passion for clinical outcomes, allowed them to navigate this product to market very quickly, and is emblematic of our mission to help patients,” said Darin Johnson, Exactech vice president of marketing for extremities.

Designed for anatomic total shoulder arthroplasty, the Stemless Shoulder features a single tray of instruments for operating room efficiency. It uses a three-dimensional porous structure with optimized pore size, count and porosity. In addition, the Stemless Shoulder incorporates a bone cage for bone through-growth to enhance the probability of biologic fixation.

“The Stemless Shoulder’s innovative combination of three-dimensional porous material and bone cage technology help differentiate it from others on the market,” said design team member Buddy Savoie III, MD, of Tulane University. “Exactech’s ability to convert design team concepts and ideas into a reality is quite impressive, and I am certain surgeons will be eager to learn more about this meaningful technology.”

Joining Dr. Savoie on the design team were Pierre-Henri Flurin, MD, of Clinique du Sport in Bordeaux-Mérginac, France; Curtis Noel, MD, of Crystal Clinic Orthopaedic Center in Akron, Ohio; Ryan Simovitch, MD, of Palm Beach Orthopaedic Institute in Palm Beach Gardens, Fla.; Thomas Wright, MD, of the University of Florida; and Joseph Zuckerman, MD, of NYU Langone Orthopaedic Hospital.

Exactech plans to initiate targeted clinical evaluation of the Stemless Shoulder immediately, and will aggressively expand the release throughout the second half of the year.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at https://staging.exac.com.

Media Contact

Priscilla Bennett
Vice President Corporate & Marketing Communication
Exactech

media@exac.com
352-377-1140

Exactech Knee System, Ankle, Shoulder Stem, Hip Stem and Computer-Assisted Surgery Technology Headline at Booth #5023, AAOS 2018 Annual Meeting

GAINESVILLE, Fla. (March 6, 2018) – Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today its lineup of products to be showcased at the company’s educational exhibit at Booth #5023 at the American Academy of Orthopaedic Surgeons (AAOS) 2018 Annual Meeting, March 7-9, in New Orleans, La.

The Exactech innovations and educational opportunities to be showcased at Booth #5023 are featured on the company website and include:

The new Truliant® Knee System, a surgeon inspired primary and revision knee system designed for an efficient and reproducible experience, featuring Exactech’s new award-winning instrumentation. Seamlessly integrating with the ExactechGPS® guided personalized surgery system, Truliant supports a simple transition to computer-assisted surgery for real-time data and guidance with only two block changes using the new ExactechGPS TKA Plus Application.

The Equinoxe® Preserve is the next generation platform shoulder stem. Designed to preserve distal humeral bone while also achieving optimal stability and fixation, this platform stem is compatible with the Equinoxe® Shoulder System that uniquely focuses on anatomical replication, reverse shoulder arthroplasty and options for difficult glenoids and revisions. It can be used with the ExactechGPS Shoulder Application, the only computer-assisted surgical technology for shoulder arthroplasty. It supports surgeons from pre-operative planning through real-time execution.

The Alteon® HA Femoral Hip Stem with hydroxyapatite-coating is designed to be bone conserving, while providing initial stability to promote biologic fixation. It features reduced stem lengths, incremental stem sizing, and proportional neck geometry with a broach-only technique that offers flexibility to accommodate various surgical approaches.

The Vantage® Total Ankle System represents a new perspective in ankle arthroplasty and is Exactech’s first product in the foot and ankle market. The Vantage ankle focuses on antaomic design, fixation, biomechanics, bone removal, reliability and revision.

The InterSpace® Tapered Wedge hip spacer provides surgeons the same consistent local antimicrobial activity as the cylindrical spacer, in a new wedge-style stem design to treat patients following peri-prosthetic joint infection.

Reveille® Cartilage Processor, a cost-effective option for single stage surgery with autologous cartilage, is used for intraoperative resizing of autologous tissue into usable particles.

Scientists and surgeon consultants are scheduled at the Exactech booth to share their experiences with the company’s products. Attendees may also learn about Exactech’s patient education and practice marketing programs.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at https://staging.exac.com.

Media Contact

Priscilla Bennett, APR
Exactech Vice President, Corporate & Marketing Communication
(352) 377-1140
media@exac.com

Orthopaedic Industry Veteran Jeffrey R. Binder Joins Bill Petty, MD, as Co-Executive Chairman of Exactech; Daniel Hann Joins Exactech as Sr. Vice President of Business Development

GAINESVILLE, Fla. (March 5, 2018) – Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today the appointment of Jeffrey R. Binder who joins Bill Petty, MD as Co-Executive Chairman following the company’s recent go-private merger agreement with TPG Capital.

Binder, 25-year veteran of the medical device and diagnostics industry, has proven expertise in helping companies realize growth opportunities. He has served in CEO roles for Biomet and Immucor, and previously held senior roles at Abbott and Johnson & Johnson.

Daniel Hann, who held leadership positions with Biomet for more than 25 years, has also joined Exactech as Senior Vice President of Business Development.

“I am excited to join a company that I have admired for many years.” Binder said. “Exactech has made its mark through its excellent products and also as a company that lives its values. I look forward to working with Dr. Petty, CEO David Petty and the rest of Exactech’s passionate team as we grow to reach even more surgeons and patients around the globe.”

Exactech CEO David Petty said “We are excited to have Jeff and Dan joining the Exactech team. Their years of relevant experience and compatibility with our culture will make them valuable leaders and contributors to our future success.”

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at https://staging.exac.com.

Media Contact

Priscilla Bennett, APR
Exactech Vice President, Corporate & Marketing Communication
(352) 377-1140
media@exac.com