510(k) Report

Devices descending from K974016

24 later devices reach Cerclage Cable with Hex Button through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063009Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Praesidia S.R.L.20061—
+1K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.200310—
+1K992617Hex ButtonPioneer Surgical Technology199910—
+2K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+2K233949ACCORD Cable SystemSmith & Nephew, Inc.20240—
+2K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+2K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew20231—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20200—
+2K173910Impress SFS SystemCable Fix Medical, LLC20180—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.20090—
+2K091799Cable Ready Cable Grip System Cable ButtonZimmer, Inc.20097—
+2K043252Cabling System Trochanter HookSmith & Nephew, Inc.20051—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+4K261038Xpert PFPNewclip Technics20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—