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Biomendex was granted FDA 510(k) clearance to market Adaptos Fuse Bone Graft as a bone graft substitute for filling bony voids or gaps that are not intrinsic to the stability of the bony structure in the spine area. This clearance marks the company’s entry into the U.S. bone graft substitute market.
This milestone represents the first FDA clearance for human clinical use of Biomendex’s proprietary bone regeneration platform technology. The platform has previously been utilized in more than 2,700 veterinary orthopedic and dental procedures, providing extensive real-world surgical experience prior to its introduction into human clinical practice.
Biomendex plans to initiate phased U.S. commercialization in accordance with cleared labeling, focusing on targeted spine segments. The company is advancing distribution and partnership discussions to support market entry and drive adoption among qualified healthcare professionals trained in appropriate surgical techniques.
Adaptos Fuse is indicated for use in surgically created osseous defects and defects resulting from traumatic injury, including indications such as the posterolateral spine, intervertebral disc space, and the pelvic area. In interbody fusion, Adaptos Fuse is intended for use with interbody fusion devices that are FDA-cleared for the indication. The material is designed to resorb over time and be replaced by bone during the natural healing process.
Adaptos Fuse has been engineered to integrate into standard surgical techniques, with handling characteristics intended to support intraoperative efficiency. Its design also supports robust combination with autograft and postoperative imaging visibility, an important consideration in clinical follow-up.
“FDA 510(k) clearance of Adaptos Fuse marks a transformational milestone for Biomendex,” said Pasi Kankaanpää, CEO of Biomendex. “We are now positioned to enter the U.S. market with a scalable synthetic bone graft solution built on years of platform development and veterinary clinical experience. This clearance validates our technology and establishes a foundation for commercial growth in spine applications.”
Source: Biomendex
Biomendex was granted FDA 510(k) clearance to market Adaptos Fuse Bone Graft as a bone graft substitute for filling bony voids or gaps that are not intrinsic to the stability of the bony structure in the spine area. This clearance marks the company's entry into the U.S. bone graft substitute market.
This milestone represents the first FDA...
Biomendex was granted FDA 510(k) clearance to market Adaptos Fuse Bone Graft as a bone graft substitute for filling bony voids or gaps that are not intrinsic to the stability of the bony structure in the spine area. This clearance marks the company’s entry into the U.S. bone graft substitute market.
This milestone represents the first FDA clearance for human clinical use of Biomendex’s proprietary bone regeneration platform technology. The platform has previously been utilized in more than 2,700 veterinary orthopedic and dental procedures, providing extensive real-world surgical experience prior to its introduction into human clinical practice.
Biomendex plans to initiate phased U.S. commercialization in accordance with cleared labeling, focusing on targeted spine segments. The company is advancing distribution and partnership discussions to support market entry and drive adoption among qualified healthcare professionals trained in appropriate surgical techniques.
Adaptos Fuse is indicated for use in surgically created osseous defects and defects resulting from traumatic injury, including indications such as the posterolateral spine, intervertebral disc space, and the pelvic area. In interbody fusion, Adaptos Fuse is intended for use with interbody fusion devices that are FDA-cleared for the indication. The material is designed to resorb over time and be replaced by bone during the natural healing process.
Adaptos Fuse has been engineered to integrate into standard surgical techniques, with handling characteristics intended to support intraoperative efficiency. Its design also supports robust combination with autograft and postoperative imaging visibility, an important consideration in clinical follow-up.
“FDA 510(k) clearance of Adaptos Fuse marks a transformational milestone for Biomendex,” said Pasi Kankaanpää, CEO of Biomendex. “We are now positioned to enter the U.S. market with a scalable synthetic bone graft solution built on years of platform development and veterinary clinical experience. This clearance validates our technology and establishes a foundation for commercial growth in spine applications.”
Source: Biomendex
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
