# K240407: ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Mar 7, 2024 after 27 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: 11 generations back to K961555 (1996). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 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 5.
- K170098: ICONIX TT All Suture Anchor, Stryker (2017) Summary page 5.
- K151201: Stryker ICONIX with Needles, Stryker (2015) Summary page 5.
- K173074: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor, Stryker (2018) Summary page 5.

## Indications for use
The Stryker ICONIX anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed 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 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, llliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/Reconstruction, Quadriceps Tendon Repair. Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair. The Stryker ICONIX Anchors are intended for single use only.

Source page: https://510kreport.com/device/K240407
Methodology: https://510kreport.com/methodology