Aevumed PHANTOM Suture Anchors

The Aevumed PHANTOM Suture Anchors are PEEK-based suture anchors preloaded on disposable inserter assemblies, available in 3.5mm and 4.5mm diameters. They are used for soft tissue-to-bone fixation across multiple orthopedic procedures including rotator cuff repair, ligament reconstruction, and tendon repair in the shoulder, knee, foot/ankle, hand/wrist, elbow, and hip. The device is intended for patients age 18 and older and is prescribed by physicians.

The PHANTOM Suture Anchors share identical intended use, geometric design, material (PEEK), operational principle, sterilization method, packaging, and shelf life with the predicate RAPID Anchor (K223878). The minor differences between the modified PHANTOM and predicate RAPID do not raise new safety or effectiveness questions. Testing showed the PHANTOM demonstrated significantly higher pullout strength compared to the RAPID predicate.

Not stated in this summary.

Substantial equivalence is established through non-clinical mechanical testing (insertion, cyclic tensile, and static tensile testing) demonstrating that the PHANTOM meets or exceeds the performance of the predicate RAPID device. Sterilization, packaging, pyrogenicity/endotoxin monitoring, and biocompatibility are identical between devices. The PHANTOM's higher pullout strength indicates improved or equivalent performance for the same intended orthopedic fixation uses, with no safety or efficacy concerns raised by the minor design differences.