510(k) Report

Devices descending from K983641

31 later devices reach Holland Femoral Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign)20092—
+1K072161Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp2007228
+1K050118Ebi Trochanteric Nail SystemEbi, L.P.200573
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+2K153759SIGN Compression Screw SystemSign Fracture Care International20160—
+2K152757SIGN Hip Construct (SHC)Sign Fracture Care International20150—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+2K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+2K081230Trauson Intramedullary NailTrauson (Jiangsu) Medical Instrument Co., Ltd.20090—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.20204—
+3K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+3K172699Agile NailOrthofix Srl20180—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+4K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+4K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—