510(k) Report

Devices descending from K133585

34 later devices reach Inbone Total Ankle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193067The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total…Wrightmedicaltechnologyinc20202—
+1K180730INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc20183—
+1K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+1K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc201629—
+1K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc201529—
+2K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)20251—
+2K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+2K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+2K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc201713—
+2K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc201716—
+2K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc201717—
+3K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)20260—
+3K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas20212—
+3K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc20213—
+3K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+3K193432Vantage PSI System3D Systems20206—
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+4K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+4K241326Cadence Ankle PSI System3D Systems, Inc.20241—
+4K241148Salto Talaris Ankle PSI System3D Systems, Inc.20241—
+4K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+4K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas20240—
+4K231585Vantage PSI System3D Systems, Inc.20230—
+4K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc20232—
+4K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)20241—
+5K243173Salto Talaris Ankle PSI System3D Systems, Inc.20240—
+5K243174Cadence Ankle PSI System3D Systems, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—