Exactech, Statera partner on world’s first smart reverse shoulder implant

Exactech announced today that it partnered with Statera Medical to design the world’s first smart reverse shoulder implant.

The companies plan to co-develop the new implant over the next few years.

Samuel Bourdon, Statera’s CEO, said in a news release that the company developed its Goldilocks smart implant technology to give surgeons more precision. These smart implants, which provide more objective data, can help surgeons select the correct implant size and offset. Surgeons can also utilize the implants to provide the best balance of joint mobility and stability for all major joints.

The Statera technology, which has FDA breakthrough device designation, provides real-time data and adjustment capabilities. In the partnership, the companies plan to integrate Goldilocks into the Exactech Equinoxe shoulder system.

According to Chris Roche, Exactech SVP of extremities, surgeons currently have a subjective process to select reverse shoulder…

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FDA warns on defective packaging with Exactech shoulder system

The Equinoxe shoulder system. [Image courtesy of Exactech]The FDA issued a warning related to possible health risks associated with the Exactech Equinoxe shoulder system joint replacement devices.

Equinoxe devices replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue present.

Exactech manufactured these devices between 2004 and August 2021, packaging them in defective bags, the agency says. The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation. This chemical reaction can degrade plastic components over time.

Oxidation can lead to faster device wear or failure, plus device component cracking or fracture. This could in turn lead to additional surgeries to replace or correct the Equionoxe shoulder implant.

The FDA …

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Exactech wins clearance for new ankle surgery navigation system

ExactechGPS Ankle [Image courtesy of Exactech]Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle.

The Gainesville, Florida–based company described the system as the first of its kind for total ankle arthroplasty. It connects the preoperative plan with real-time intraoperative instrument guidance, confirming that resections meet the surgical plan.

Designed to improve surgical precision, the ExactechGPS Ankle combines propriety active tracker technology with a touchscreen tablet, providing dynamic feedback to surgeons during procedures.

“I am already a fan of Exactech’s patient-specific instrumentation solution and am thrilled how GPS Ankle provides intraoperative flexibility at my fingertips. The ability to quantify soft tissue laxity will be a game changer for me and my patients,” said design team surgeon Dr. Edward Haupt of the Mayo Clinic in Florida.

GPS Ankle has compatibility with Exacte…

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Exactech promotes from within to fill CEO spot

New CEO Darin Johnson. [Image courtesy of Exactech]Exactech announced today that it promoted Darin Johnson, the company’s president, to the position of CEO.

Johnson took over as interim CEO for the Gainesville, Florida-based orthopedic implant maker in March 2023. He now succeeds Jeffrey Binder, chair of Exactech’s board of directors.

Since joining Exactech in 2002, Johnson has held a number of executive-level leadership roles. As president, he oversaw all of the company’s business units, as well as human resources and information technologies functions. Before that, Johnson led the extremities business unit.

Over his stint at Exactech, Johnson’s experience includes building nad leading cross-functional, global teams. Those teams include orthopedic surgeons, product managers, engineers and sales professionals.

Binder highlighted Johnson’s “excellent job guiding Exactech over the past six months.” He cited yea…

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Exactech debuts new knee replacement system

The TriVerse implant. [Image courtesy of Exactech]Exactech today announced the first cases performed with its new TriVerse primary knee system for knee replacement procedures.

Gainesville, Florida-based Exactech designed the evidence-based, streamlined solution to address the increasing demands of knee replacement. Orthopedic surgeons Dr. Chris Christensen and Dr. David Taunton performed the first TriVerse knee surgeries. Christensen operates out of Bluegrass Orthopaedics in Lexington, Kentucky. Taunton works at Texas Orthopedic Specialists in Bedford, Texas.

“Efficiency and flexibility are of paramount importance to me and my O.R. staff. Exactech’s TriVerse Knee system has been designed with a streamlined, simplified approach while offering a comprehensive array of primary knee implants that give me the best of both worlds,” said Christensen.

Taunton added that TriVerse’s design “leans on the successful clinical heritage” of previou…

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FDA clears knee replacement polyethylene from Exactech

The Activit-E knee replacement polyethylene. [Image courtesy of Exactech]Exactech announced today that it received FDA 510(k) clearance for its new advanced Activit-E polyethylene for the Truliant system.

Gainesville, Florida-based Exactech designed the Activit-E polyethylene for its Truliant knee replacement system. It combines material strength and toughness through chemically crosslinked polyethylene. It also eliminates the need for gamma irradiation technology used in previous polyethylene generations.

Exactech said its design helps to maintain oxidative resistance and long-term performance, including strength and stabilization.

“After years of research and development in polyethylene, Activit-E represents a breakthrough achievement for Exactech. It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients,” said Adam Hayden, CMO a…

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Exactech announces global release of next-gen GPS Shoulder

[Image courtesy of Exactech]Exactech will mark the global release of the latest version of its ExactechGPS shoulder surgery navigation software at the annual Shoulder Masters Course in Amsterdam later this week.

The launch is taking place in EMEA and APAC countries. It follows the first surgery in the United Arab Emirates earlier this month, leveraging the company’s Active Intelligence suite, which uses ExactechGPS and the Equinoxe planning app.

“ExactechGPS is designed to dramatically improve accuracy. The human eye allows implant placement by even the most experienced surgeons, to within 3 to 5 millimeters. However, with the guidance of GPS technology, more precise implant placement, within 1-2 mm, is possible,” said UAE-based British orthopedic and trauma surgeon Dr. Ved Goswami of Medclinic City Hospital. Goswami performed the recent surgery with assistance from U.S. shoulder and elbow surgeon Dr. Stephanie Muh, of Henry Ford Health.

The U.S. rele…

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Materialise, Exactech partner on 3D-printed shoulder implants

[Image courtesy of Materialise]Materialise announced today that it entered into a collaboration with Exactech to provide 3D-printed implants for shoulder defects.

Leuven, Belgium-based Materialise provides 3D planning and printing solutions for medical applications. Gainesville, Florida-based Exactech develops innovative implants, instrumentation and smart technologies for joint replacement surgery.

Together, they aim to include the Materialise Glenius solution in the Exactech portfolio. This would enable surgeons to help patients with personalized implants in Europe and Australia.

In a news release, Materialize said orthopedic surgeons can leverage its personalized implants to treat patients with substantial glenoid bone loss. These patients fail to receive sustainable results from standard and augmented reverse shoulder implants.

“By including the Materialise Glenius implant into our existing offering, we’re providing surgeons in Europe and Austral…

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Exactech taps Zimmer Biomet veteran as new CFO

New CFO Tony Collins. [Image from Exactech]Exactech announced today that it appointed industry veteran Tony Collins as its new chief financial officer.

Collins joins Gainesville, Florida-based Exactech from medical device and data startup Xenter, Inc. He also served as CFO there.

Before Xenter, Collins spent 11 years at orthopedic implant giant Zimmer Biomet. He most recently held the position of group chief financial officer at Zimmer Biomet. His responsibilities included strategic and financial planning, business development, accounting and internal controls for the company’s global business units.

“I am excited to welcome Tony to our executive team,” said Exactech CEO Jeff Binder. “His expertise, including his deep domain knowledge, will be very beneficial to our business as we drive profitable growth and capitalize on the critical investments we are making in innovative products and advanced technologies.”

Collins also spent time as VP of f…

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Exactech launches total hip arthroplasty system

Exactech announced today that the first successful surgeries were completed with its Spartan Stem and Logical Cup systems.

Gainesville, Florida-based Exactech designed the systems for total hip arthroplasty.

The Spartan Stem features three offset options and a tapered, polished distal segment, while the Logical Cup, a modular acetabular system, enables an efficient surgical workflow in hospitals and ambulatory surgical centers, the company said in a news release.

“Our aim is to deliver what physician and institutional customers have been demanding, which is efficient instruments, clinical,ly-advanced implants and ASC-friendly solutions,” said Adam Hayden, chief marketing officer and SVP of large joints for Exactech. “The Spartan Stem and Logical Cup enhance the clinical breadth and depth of our Hip offering and—in combination with our Alteon hip system—reflect our mission to Improve the Proven and deliver a rich and differentiated portfolio of orthopaedi…

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Exactech launches new version of Equinoxe shoulder preoperative software

Exactech this week launched its Equinoxe Shoulder Planning App v2.1 in the U.S.

The preoperative planning software is designed for use with the company’s ExactechGPS navigation system in the operating room to connect the preoperative plan with implant placement. The Gainesville, Florida-based company designed the software to give surgeons increase flexibility to plan shoulder component placement and select implants and sizes for scapula and humerous made for a patient’s specific anatomy.

Equinoxe’s latest version has humeral planning with varying humeral stem components and sizes; views for stem anterior/posterior, medial/lateral and inclination positions; humeral head offset and position adjustment in anatomic procedures; patient neutral abduction position refinement and views of the total join and use of combined motions to assess shoulder range of motion and impingement.

In a recent study, the ExactechGPS navigation system provided v…

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Exactech announces first procedures with new instrumentation for Newton knee tech

[Image from Exactech]Exactech announced today that the first surgeries were performed using its Newton knee and new, user-friendly instrumentation.

Gainesville, Florida-based Exactech designed the Newton knee with soft tissue balancing technology for total knee replacements with a modernized graphical user interface to accompany the new instrumentation.

According to a news release, Stanford University’s Dr. James Huddleston, Cornerstone Orthopedic Institute’s Dr. Raul Marquez and Rush Memorial Hospital’s Dr. Jeffrey R. Ginther were the first to perform surgeries with the platform.

“Optimal soft tissue balance, combined with personalized implant placement, has the potential to improve on the historical outcomes of knee replacement,” Huddleston said in the release. “Exactech is yet again leading the way with the Newton Knee, merging well-thought-out design and leading-edge technology to deliver real-time operative insights for balanced knee …

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