TurbAlign

TurbAlign is a bioabsorbable polydioxanone implant designed to hold the middle turbinate away from the lateral nasal wall during the healing phase following sinus surgery (such as endoscopic sinus surgery). The device provides short-term fixation of the middle turbinate to the nasal septum to minimize the risk of adhesion to the lateral wall, and it fully resorbs over 180 days.

TurbAlign uses an attached surgical needle for threading through tissue structures, whereas the predicate device uses a hook and barb design. TurbAlign has variable length adjustable to anatomical need, compared to the predicate's fixed length. Both devices use absorbable synthetic polymer (polydioxanone), are single-use, sterile, and made of biocompatible materials with similar intended function.

ISO 10993-1 (Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process, 2018); FDA Guidance on Use of International Standard ISO 10993-1 (September 8, 2023). Tests performed included cytotoxicity, sensitization, irritation, implantation, and chemical characterization.

Both devices share the same primary technological principle—separating the middle turbinate from the lateral nasal wall using an absorbable synthetic polymer during post-surgical healing. The design differences (attached needle vs. hook-and-barb, variable vs. fixed length) do not raise different safety or effectiveness questions because performance testing—including mechanical integrity, comparative anchoring feature testing, and cadaver usability studies—demonstrated the subject device performs equivalently to the predicate in medializing tissue. Biocompatibility testing confirmed material safety. Therefore, the subject device is substantially equivalent despite these design variations.