# K171465: Stryker Self-Punching ICONIX

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Aug 24, 2017 after 98 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: 12 generations back to K911837 (1991). 98 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133671: Iconix All Suture Anchors, Stryker Corp. (2014) Summary page 4.
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures, Conmed Corporation (2014) Summary page 4.

## Most influential descendants
- K172921: Stryker Self-Punching ICONIX (2017), 0 descendants of its own

## Indications for use
The Stryker Self-Punching ICONIX Anchors are intended 1o be used for soft tissue-to-bone fixation in the elbow, shoulder, knee, and hip. See indications below. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Obligue Ligament Repair, [lliotibial Band Tenodesis Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

Source page: https://510kreport.com/device/K171465
Methodology: https://510kreport.com/methodology