Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors— 510(k) K222763

Name: FDA 510(k) clearance K222763
Creator: U.S. Food and Drug Administration
Published: 2022-10-13

Substantially Equivalent

Responsive Arthroscopy, LLC

FDA 510(k) clearance K222763 for Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors, Substantially Equivalent on 2022-10-13. Applicant: Responsive Arthroscopy, LLC. Device class: 2.

Clearance details

Applicant: Responsive Arthroscopy, LLC
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2022-09-13
Decision date: 2022-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

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K253065 — Aevumed SUPERCYNCH Button System2026-09-02
K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
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

More clearances from Responsive Arthroscopy, LLC

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K253010 — Mini Superhawk Suture Anchor System2025-10-14
K233258 — Shadow Knotless All-Suture Anchors2023-10-23
K230094 — Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors2023-08-25
K203121 — Responsive Arthroscopy Thunderbolt System2021-04-27
K202569 — Responsive Arthroscopy Interference Screw System2020-09-23

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.