510(k) Report

Devices descending from K923277

238 later devices reach Foundation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+6K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K254003JARVIS Metaphyseal StemFH Industrie20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+7K250477NextAR (TM) SpineMedacta International S.A.20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+7K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+7K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+7K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+7K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+8K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301