510(k) Report

Devices descending from K935646

25 later devices reach FX-Cablelok (TM) Stop (Trochanter Hook) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971682J-FX Cerclage SystemJohnson & Johnson Professionals, Inc.199724—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K982545BMP Cable SystemBiomet, Inc.1998171
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K133354Peri-Prosthetic Cable SystemBiomet, Inc.20140—
+3K072250Supercable Grip and Plate SystemKinamed, Inc.200711
+3K043252Cabling System Trochanter HookSmith & Nephew, Inc.20051—
+3K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.200310—
+3K023564Osse-LignOsseus, LLC20030—
+3K024022Osteo-Cable SleeveBiomet, Inc.20030—
+3K013657Modification to: Biomet Humeral Cable PlatesBiomet Orthopedics, Inc.20010—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K233949ACCORD Cable SystemSmith & Nephew, Inc.20240—
+4K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew20231—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20200—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—