# K151201: Stryker ICONIX with Needles

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jun 29, 2015 after 55 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: 9 generations back to K961555 (1996). 26 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 37 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.
- K071157: Stryker Peek and Titanium Soft Eyelet Anchors, Stryker Endoscopy (2007) Summary page 4.

## Most influential descendants
- 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
- K233468: Iconix Anchor (2023), 1 descendant of its own
- K262677: Iconix Knotless T (2026), 0 descendants of its own

## Indications for use
The Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. 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 Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor And Extensor Tendons at the PIP, DIP, and MCP Joint 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, Iliotibial Band Tenodesis Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

Source page: https://510kreport.com/device/K151201
Methodology: https://510kreport.com/methodology