Osprey Suture Anchor— 510(k) K243726

Name: FDA 510(k) clearance K243726
Creator: U.S. Food and Drug Administration
Published: 2025-01-30

Substantially Equivalent

Responsive Arthroscopy, Inc.

FDA 510(k) clearance K243726 for Osprey Suture Anchor, Substantially Equivalent on 2025-01-30. Applicant: Responsive Arthroscopy, Inc.. Device class: 2.

Clearance details

Applicant: Responsive Arthroscopy, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2024-12-03
Decision date: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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

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K261632 — Thunderbolt System2026-07-20

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.