510(k) Report

Devices descending from K932246

37 later devices reach Foundation Metal-Backed Patella through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+1K973672Foundation Plasma Sprayed Metal-Backed PatellaEncore Orthopedics, Inc.19970—
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+2K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+6K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+6K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+6K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+7K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301