510(k) Report

Devices descending from K203399

9 later devices reach Fitbone (R) Taa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl20260—
+1K233867Fitbone TrochantericOrthofix Srl202421
+1K232169FITBONE® Transport and Lengthening SystemOrthofix Srl20242—
+1K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20233—
+2K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+2K260146Fitbone® Transport and Lengthening SystemOrthofix Srl20260—
+2K250112FitboneTM TrochantericOrthofix Srl20250—
+2K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated202311
+2K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—