510(k) Report

Devices descending from K142117

29 later devices reach Invision Total Ankle Revision System through their predicates, nearest generation first.

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