510(k) Report

Devices descending from K113219

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+1K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20172—
+1K131490Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201414—
+2K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc.20191—
+2K163368Fitbone TaaWittenstein Intens GmbH201710—
+3K203399Fitbone (R) TaaWittenstein Intens GmbH20219—
+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—
+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—