510(k) Report

Devices descending from K063570

37 later devices reach Biomet Tibial Locking Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+1K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+1K170972Apex Tibial Nailing SystemOrthoxel20171—
+1K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+1K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma200818—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+2K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+2K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+2K102577Force Medical IM Nail SystemForce Medical, Inc.20120—
+3K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K163589SIGN IM NailSign Fracture Care International20170—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123