510(k) Report

Devices descending from K081127

25 later devices reach Accin Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+1K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+1K152382Arthrex iBalance TKA SystemArthrex, Inc.20152—
+1K143047Arthrex iBalance Patella Implant, DomeArthrex, Inc.20142—
+1K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+1K133854Arthrex Ibalance Tka SystemArthrex, Inc.20144—
+1K133342Arthrex Ibalance Tka SystemArthrex, Inc.20130—
+1K101032Cardo Medical Femoral Cement Restrictor, Model 503-MCRXCardo Medical, Inc.20100—
+1K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp.20090—
+2K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+2K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+2K171365Arthrex Knee SystemsArthrex, Inc.20170—
+2K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+3K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+3K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+3K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+3K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+3K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+4K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+4K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+4K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+4K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+4K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—