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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K261632
Device Name Thunderbolt System
Applicant
Responsive Arthroscopy, Inc.
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Applicant Contact Gretchen Hinchley
Correspondent
Responsive Arthroscopy, Inc.
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Correspondent Contact Gretchen Hinchley
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received05/18/2026
Decision Date 07/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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