510(k) Report

Devices descending from K983358

36 later devices reach G/K SFN and STN Locking Nails through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc.2001351
+2K163653NOVOS-NAIL Limb Lengthening System (LLS)Smith & Nephew20170—
+2K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2011292
+2K031875Inter-OS Limb LengthenerInter-Os Technologies20034—
+2K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc.2003301
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20172—
+3K131490Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201414—
+3K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201321—
+3K113219Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201215—
+3K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+3K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+4K203399Fitbone (R) TaaWittenstein Intens GmbH20219—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc.20191—
+4K163368Fitbone TaaWittenstein Intens GmbH201710—
+4K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated201562
+4K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20153—
+4K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+4K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20149—
+4K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201319—
+5K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl20260—
+5K233867Fitbone TrochantericOrthofix Srl202421
+5K232169FITBONE® Transport and Lengthening SystemOrthofix Srl20242—
+5K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20233—
+5K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20165—
+5K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+5K141739Residual Limb Lengthening SystemEllipse Technologies, Inc.201402
+6K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+6K260146Fitbone® Transport and Lengthening SystemOrthofix Srl20260—
+6K250112FitboneTM TrochantericOrthofix Srl20250—
+6K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated202311
+6K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+6K170346PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20171—
+6K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—