Aevumed FASE Suture Anchor

The Aevumed FASE Suture Anchor is a PEEK-based suture anchor preloaded on a disposable inserter for soft tissue-to-bone fixation across multiple joint sites including the shoulder, knee, ankle, foot, hip, elbow, wrist, and hand. It is intended for various orthopedic repairs including rotator cuff repair, ligament reconstruction, and tendon repair in patients age 18 and older.

The FASE anchor is available in 4.75mm and 5.5mm diameter sizes, sterile and single-use. It shares the same intended use, geometric design, material (PEEK), operational principle, sterilization method, packaging, and shelf life as the predicate PHANTOM anchor. The FASE has a larger diameter and modified thread design compared to the predicate, but these differences do not raise new safety or effectiveness questions.

Not stated in this summary. The document references mechanical pullout strength testing and biocompatibility testing but does not cite specific consensus standards such as ISO, IEC, or ASTM numbers.

The FASE anchor is substantially equivalent to the predicate PHANTOM anchor because both devices share the same intended use, material composition, sterilization, packaging, and biocompatibility profile. The FASE demonstrated significantly higher pullout strength in mechanical testing. The minor differences in diameter and thread design do not raise new questions of safety and effectiveness, and the device should perform comparably to the predicate currently marketed for the same indications.