510(k) Report

Devices descending from K031219

30 later devices reach Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2011292
+2K163653NOVOS-NAIL Limb Lengthening System (LLS)Smith & Nephew20170—
+2K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20172—
+2K131490Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201414—
+2K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201321—
+2K113219Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201215—
+2K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+3K203399Fitbone (R) TaaWittenstein Intens GmbH20219—
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+3K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc.20191—
+3K163368Fitbone TaaWittenstein Intens GmbH201710—
+3K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated201562
+3K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20153—
+3K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+3K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20149—
+3K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201319—
+4K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl20260—
+4K233867Fitbone TrochantericOrthofix Srl202421
+4K232169FITBONE® Transport and Lengthening SystemOrthofix Srl20242—
+4K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20233—
+4K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20165—
+4K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+4K141739Residual Limb Lengthening SystemEllipse Technologies, Inc.201402
+5K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+5K260146Fitbone® Transport and Lengthening SystemOrthofix Srl20260—
+5K250112FitboneTM TrochantericOrthofix Srl20250—
+5K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated202311
+5K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+5K170346PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20171—
+5K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—