Iconix Knotless Anchor— 510(k) K240213

Name: FDA 510(k) clearance K240213
Creator: U.S. Food and Drug Administration
Published: 2024-02-23

Substantially Equivalent

Riverpoint Medical

FDA 510(k) clearance K240213 for Iconix Knotless Anchor, Substantially Equivalent on 2024-02-23. Applicant: Riverpoint Medical. Device class: 2.

Clearance details

Applicant: Riverpoint Medical
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2024-01-25
Decision date: 2024-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

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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
K261770 — Suture Button Repair System2026-07-29
K261632 — Thunderbolt System2026-07-20

More clearances from Riverpoint Medical

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K253024 — ProZip Knotless Implant2025-10-16
K252201 — HS Fiber2025-08-13
K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor2025-07-30
K243323 — Iconix Knotless Anchor2024-11-19
K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor2024-10-29

Adverse events under product code MBI

product code MBI

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.