# K133671: Iconix All Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Feb 28, 2014 after 91 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: 8 generations back to K961555 (1996). 23 ancestors in all.
25 later devices descend from it; 8 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120509: Stryker All Suture Anchors, Stryker (2012) Summary page 1.
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK), Smith & Nephew, Inc. (2011) Summary page 1.

## Most influential descendants
- K151201: Stryker ICONIX with Needles (2015), 10 descendants of its own
- K173074: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor (2018), 5 descendants of its own
- K231078: All-Suture Anchor (2023), 3 descendants of its own
- K231278: Knotless Suture Anchor (2023), 3 descendants of its own
- K221396: Arthrex FiberTak Suture Anchor (2022), 3 descendants of its own

## Indications for use
Elbow: Biceps Tendon Re-attachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair. SLAP Lesion Repair. Biceps Tenodesis. Acromia-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Repair Hand/Wrist: Scaphulo lunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP. DIP and MCP Joints for all Digits, Digital Tendon Repair Foot/Ankle: Lateral Stabilization. Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction. Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, I liotibial Band Tenodesis. Hip: Capsular Repair. Acetabular Labral Repair, Gluteal Tendon Repair The ICONIX All Suture Anchors are intended for single use only.

Source page: https://510kreport.com/device/K133671
Methodology: https://510kreport.com/methodology