510(k) Report

Devices descending from K791125

20 later devices reach Plug-Lok Cement Restirctor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K210062Mectaplug PE IIMedacta International S.A.20210—
+1K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+1K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+1K023680Biobuck Cement RestrictorSmith & Nephew, Inc.20020—
+2K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+2K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—