510(k) Report

Devices descending from K012158

14 later devices reach Modification to: Long Length Gamma Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.20021312
+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—
+2K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+2K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.201111—
+2K042440Alphatec Femoral Trochanteric Nail (FTN) SystemAlphatec/Nexmed20040—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+3K221115Flow-NailFlow-Fx, LLC20221—
+3K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+4K234075Flow-NailFlow-Fx, LLC20240—