# K172921: Stryker Self-Punching ICONIX

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 20, 2017 after 56 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911837 (1991). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171465: Stryker Self-Punching ICONIX, Stryker (2017) Summary page 4.

## Indications for use
The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

Source page: https://510kreport.com/device/K172921
Methodology: https://510kreport.com/methodology