510(k) Report

Devices descending from K002356

143 later devices reach Natural-Knee II Patellofemoral Joint Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+6K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+6K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+6K171365Arthrex Knee SystemsArthrex, Inc.20170—
+6K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+6K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+6K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+6K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+6K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+6K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+7K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+7K211938Physica LMC Knee SystemLimacorporate20210—
+7K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+7K201084Physica systemLima Corporate S.P.A.20205—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+7K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+8K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+8K210554Physica systemLima Corporate S.P.A.20212—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+8K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+9K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+9K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301