510(k) Report

Devices descending from K070033

16 later devices reach Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+1K143323OS2-V Varisation StapleIn2bones Sas20155—
+1K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K210456Ligament StapleMedacta International S.A.20210—
+2K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+2K153770OS2(R)-VP Varisation StapleIn2bones Sas20164—
+2K153395OS2-C Compression StapleIn2bones Sas20167—
+3K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+3K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+3K170688PIT’Stop® implantIn2bones Sas20171—
+3K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—