Thunderbolt System— 510(k) K261632

Name: FDA 510(k) clearance K261632
Creator: U.S. Food and Drug Administration
Published: 2026-07-20

Substantially Equivalent

Responsive Arthroscopy, Inc.

FDA 510(k) clearance K261632 for Thunderbolt System, Substantially Equivalent on 2026-07-20. Applicant: Responsive Arthroscopy, Inc.. Device class: 2.

Summary

Responsive Arthroscopy's Thunderbolt System is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list the system's components or materials.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).

Responsive Arthroscopy filed from Minneapolis, Minnesota. The decision came 63 calendar days after FDA received it (May 18 to July 20, 2026).

Clearance details

Applicant: Responsive Arthroscopy, Inc.
Product code: Product code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-05-18
Decision date: 2026-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.