510(k) Report

Devices descending from K153395

7 later devices reach OS2-C Compression Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+1K163440Stealth Staple SystemFirst Ray, LLC20173—
+2K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+2K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+2K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+2K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—