ICONN Square 2.5MM Suture Anchor— 510(k) K172491

Clearance details

Applicant

Iconn Orthopedics, LLC

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2017-08-17

Decision date

2017-11-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Birmingham, AL, US

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• K262677 — Iconix Knotless T2026-08-27
• K262047 — Grappler Suture Anchor System2026-08-03
• K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

• K180670 — ICONN Campbell Interference Screw2018-12-07
• K182264 — ICONN Revolution Knotless Suture Anchor2018-10-19
• K181680 — ICONN Answer II Suture Anchor2018-08-09
• K132724 — ICONN ANSWER SUTURE ANCHOR2014-04-17

Injury

3,163

Malfunction

13,006

Other

2

Total

16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →