510(k) Report

Devices descending from K133289

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203399Fitbone (R) TaaWittenstein Intens GmbH20219—
+1K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20172—
+1K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated201562
+1K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20153—
+1K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20149—
+2K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl20260—
+2K233867Fitbone TrochantericOrthofix Srl202421
+2K232169FITBONE® Transport and Lengthening SystemOrthofix Srl20242—
+2K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20233—
+2K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc.20191—
+2K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20165—
+2K141739Residual Limb Lengthening SystemEllipse Technologies, Inc.201402
+3K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+3K260146Fitbone® Transport and Lengthening SystemOrthofix Srl20260—
+3K250112FitboneTM TrochantericOrthofix Srl20250—
+3K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated202311
+3K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+3K170346PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20171—