All-Suture Dual Anchor System

The All-Suture Dual Anchor System is a soft tissue-to-bone fixation device used in orthopedic procedures across multiple anatomical sites including the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The device consists of an implant made from ultra-high molecular weight polyethylene (UHMWPE) and associated single-use surgical instruments, available in knotted or knotless configurations, and is provided pre-sterilized with ethylene oxide.

The All-Suture Dual Anchor System implants are manufactured from the same materials and employ equivalent design philosophy, sizing, configurations, fixation methods, sterilization approach, and surgical technique as the predicate device. The document states that any differences between the submitted device and the predicate are considered minor and do not raise different safety or effectiveness questions.

Not stated in this summary. The document references bench testing performed (suture characterization, insertion testing, static and cyclic pullout force testing, biocompatibility adoption rationale, EO sterilization validation, and packaging adoption rationales) but does not cite specific ISO, IEC, or ASTM consensus standards.

Substantial equivalence is established through identical indications for use across six anatomical regions and multiple surgical procedures, identical materials (UHMWPE), equivalent design and fixation philosophy, and mechanical performance testing showing no new risks compared to the predicate Stryker All Suture Anchors (K120509). The minor design differences identified do not raise new safety or effectiveness concerns, and performance testing confirmed equivalent pullout force characteristics to the predicate device.