Penderia Technologies, a company developing wireless sensor technologies for orthopedic applications and in collaboration with MRC Global, LLC, recently received the FDA’s Breakthrough Device Designation for its Sensorized Soft Tissue Anchor System. Additionally, the system was accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP), a limited enrollment program meant to enhance market pathway collaboration for breakthrough technologies. Soft tissue anchors target procedures such as ACL reconstruction, rotator cuff repair, and ankle syndesmosis repair.
“Penderia’s implantable sensor addresses a critical gap in orthopedic soft tissue repair, where insufficient technology limits clinicians’ ability to understand and apply data on fixation tension to improve surgical precision and patient outcomes,” said Penderia inventor, co-founder, and CTO Dr. Keat Ghee Ong.
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Penderia’s device utilizes an anchor, compatible with current surgical techniques, that is embedded with proprietary wireless sensing technology to measure tension remotely throughout the entire range of joint motion during and after surgery. This direct feedback does not exist elsewhere and has the potential to improve success both at the time of surgery and during recovery.
With the Breakthrough Device Designation and TAP enrollment, Penderia will benefit from early, frequent, and strategic engagement with the FDA, reimbursement experts, specialty societies and patient organizations, along with priority review for future regulatory submissions. These programs are reserved for novel medical devices that enhance the standard of care for irreversibly debilitating conditions, with a primary goal of expediting patient access to such devices by providing support throughout the development process. This support will expedite the development, evaluation, and commercialization of Penderia’s Sensorized Soft Tissue Anchor System.
“Penderia believes our platform will improve the standard of care in soft-tissue repairs and are excited to receive the Breakthrough Device designation as validation of our vision,” said Penderia CEO Stephen Laffoon. “We look forward to engaging with the FDA through the TAP program as an important milestone on the way to clinical impact.”
