Atreon Orthopedics Expands ROTIUM® Bioresorbable Wick Indications with FDA 510(k) Clearance for Tendon Repairs
DUBLIN, Ohio, March 6, 2025 /PRNewswire/ -- Atreon Orthopedics, LLC, a Columbus based innovator in tissue healing and regenerative technologies, has received 510(k) clearance from the Food and Drug Administration (FDA) to expand the use of ROTIUM® Bioresorbable Wick to all tendon repairs—building on its proven success in rotator cuff procedures.
ROTIUM is a fully resorbable, synthetic-nanofiber scaffold designed to optimize the healing environment, promote tissue remodeling, and improve long-term outcomes. Driven by surgeon demand and clinical success in over 12,000 rotator cuff cases, ROTIUM is now being adopted for a wider range of high-volume tendon repair procedures, including Achilles, triceps, patellar, quadricep, gluteus medius and various applications for the foot and ankle.
"ROTIUM has already proven its value in rotator cuff repair, and this expanded clearance enables us to extend its benefits to an even broader range of procedures," said Ronald Bracken, CEO of Atreon Orthopedics. "Surgeons have been seeking a versatile solution for other tendon repairs, and we're proud to meet that demand. This milestone represents a significant step forward in our mission to provide cutting-edge solutions that enhance healing and improve surgical outcomes across multiple orthopedic specialties."
Jovan R. Laskovski, M.D., an orthopedic surgeon at Crystal Clinic Orthopaedic Center added, "I've used ROTIUM for several years not only for rotator cuff tears but also for abductor and hamstring repairs. It's efficient, adds virtually no extra surgical time, and has significantly reduced my retear rates."
ROTIUM®: Advancing Tendon Remodeling Beyond the Competition
- Optimized Handling – Designed for surgical utility, it withstands moisture and suturing without dissolving, fraying, or tearing.
- Enhanced Cellular Proliferation – Wicks biology at the repair site to jumpstart remodeling, outperforming market leading collagen patch products1.
- Smart Economics – A cost-effective, scalable bioaugmentation solution for various tendon repairs.
"Successful tissue regeneration hinges on enhancing cellular communication and guiding natural healing," said Dr. Jed Johnson, Co-Founder and Chief Technology Officer of Nanofiber Solutions, Atreon's development and manufacturing partner. "Our Electrospun scaffolds, used in vascular grafts, wound healing, and cartilage repair, bring the same innovation to tendon healing—modulating inflammation, promoting revascularization, and reducing scar formation for stronger, more resilient tendon repairs."
Atreon remains at the forefront of advanced regenerative healing solutions, providing surgeons with innovative tools to enhance tendon repair and improve patient outcomes. Discover more about Atreon at ROTIUM EI-Tendon Healing
1. Data on File
About Atreon Orthopedics:
Atreon Orthopedics, LLC, is a leading start-up in the field of tissue regeneration, focused on developing cutting-edge biologic solutions for orthopedic applications. By combining advanced materials science with deep biologic expertise, Atreon is pioneering a new era of orthopedic care to improve healing and help patients return to active lifestyles faster and with more reliable long-term results. For more information, please visit www.atreonortho.com and follow us on LinkedIn
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SOURCE Atreon Orthopedics