510(k) Report

Devices descending from K101997

29 later devices reach Ellipse Intramedullary Limb Lengthening System through their predicates, nearest generation first.

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