# K172491: ICONN Square 2.5MM Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Iconn Orthopedics, LLC
- Decided: Nov 29, 2017 after 104 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: 7 generations back to K961555 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an, Smith & Nephew, Inc. (2012) Summary page 5.
- K063479: Arthrex Pushlock, Arthrex, Inc. (2006) Summary page 5.
- K132724: Iconn Answer Suture Anchor, Iconn Orthopedics, LLC (2014) Summary page 5.

## Indications for use
The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications: Hip Indications: Capsule Repair, Acetabular Labrum Reattachment Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Deltoid Repair, Rotator Cuff Repair, Biceps Tenodesis. Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy. Elbow, Wrist, and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Knee: Extra Capsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus Medialis Obliquous Advancement, Iliotibial Band Tenodesis.

Source page: https://510kreport.com/device/K172491
Methodology: https://510kreport.com/methodology