510(k) Report

Devices descending from K954712

35 later devices reach Intramedullary Hip Screw (Modification) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+1K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049—
+1K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042—
+1K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.20021312
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+2K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.20204—
+2K140601Flow-NailFlow-Fx, LLC20142—
+2K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+2K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111—
+2K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.201111—
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+2K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057—
+2K042440Alphatec Femoral Trochanteric Nail (FTN) SystemAlphatec/Nexmed20040—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+3K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+3K221115Flow-NailFlow-Fx, LLC20221—
+3K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+4K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+4K234075Flow-NailFlow-Fx, LLC20240—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+5K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—