| K-number | K260004 |
| Device name | Aevumed PROTEKT Suture Anchor |
| Applicant | Aevumed, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Aevumed PROTEKT™ Suture Anchor is a PEEK-based suture anchor preloaded on a disposable inserter, available in 6.5 mm diameter, intended for soft tissue-to-bone fixation across multiple orthopedic sites including the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. It is sterile, single-use, and prescribed by physicians for patients age 18 and older.
The PROTEKT™ Anchor shares the same intended use, material (PEEK), operational principle, sterilization method, packaging, and shelf life as the predicate FASE™ Anchor. The primary design difference is an increase in anchor diameter from the predicate device, which the applicant argues does not introduce new failure modes or negatively impact mechanical integrity or functional performance.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov