510(k) Report

Devices descending from K915132

315 later devices reach MCK Maximum Congruent Knee) Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K201611Apex Knee SystemOmnilife Science20210—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+9K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+9K261576Icona Hip StemCorin, Ltd.20260—
+9K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+9K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301