Riverpoint Medical · Class II · Cleared Jul 30, 2025
| K-number | K252144 |
| Device name | Iconix Speed Anchor; Iconix Speed HA+ Anchor |
| Applicant | Riverpoint Medical |
| Product code | MBI |
| Device class | Class II |
| Decision date | Jul 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Iconix Speed Anchor and Iconix Speed HA+ Anchor are soft-tissue to bone fixation devices used for rotator cuff repair in the shoulder. Each device consists of a braided polyester anchor body containing two or three working sutures, preloaded on a disposable self-punching inserter that deploys the anchor into bone.
The subject devices differ from the predicate device (K233468 Iconix Anchor) only in technological characteristics: inserter design, packaging configuration, and anchor coating. These differences fall within the range of currently marketed devices and do not raise new safety or effectiveness concerns.
USP requirements for non-absorbable suture (except diameter); ISO 10993-1:2018 (biocompatibility); ISO 11607-1:2006 (sterile packaging); EN 62366:2015 (usability engineering); FDA guidance on bone anchors and surgical sutures.
The Iconix Speed Anchor has the same intended use, principles of operation, and sterilization processes as the predicate device. Although the inserter design, packaging, and anchor coating differ, these are technological variations within the range of existing marketed devices and have been assessed through risk analysis without raising new safety or effectiveness questions, thus satisfying substantial equivalence.
View the full FDA submission: accessdata.fda.gov