FDA.reportPublic FDA data

Total knee prosthesis implantation guide-instrument kit

Definition
A collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.
GUDID devices
727
Last updated
2026-10-06 03:50:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840097536705Identity CR KARestor3d, Inc.5253-00012026-09-25
00840097536712Identity CR KARestor3d, Inc.5253-00022026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.5253-00312026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.5253-00322026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.5253-00212026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.5253-00112026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.5253-00222026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.5253-00122026-09-25
00840097536781Identity CR KARestor3d, Inc.5253-09012026-09-25
00840097536798Identity CR KARestor3d, Inc.5253-09022026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.5253-09332026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.5253-09342026-09-25
10603295384397ATTUNEDEPUY (IRELAND)2544-00-1212016-01-27
10603295433002ATTUNEDEPUY (IRELAND)2544-00-1202016-01-27
10809160023204AVID TruCustomAVID MEDICAL, INC.BUCY004-12_00012016-09-09
10809160033944AVID TruCustomAVID MEDICAL, INC.HCMH012-14_00012016-09-09
10809160042656AVID TruCustomAVID MEDICAL, INC.ADBR025-06_00012016-09-09
10809160046098AVID TruCustomAVID MEDICAL, INC.ADVH010-26_00032016-09-09
10809160208540AVID TruCustomAVID MEDICAL, INC.CINC108-11_00032018-09-19
10809160208571AVID TruCustomAVID MEDICAL, INC.CINC111-10_00032018-09-19
10809160209455AVID TruCustomAVID MEDICAL, INC.VAML015-03_00032018-09-14
10809160209844AVID TruCustomAVID MEDICAL, INC.LAKC012-08_00012018-09-18
10809160210109AVID TruCustomAVID MEDICAL, INC.VMCL021-09_00032018-09-20
M5726556C009011Triathlon AS-1 PS Ream CS Insert Cemented Instrumentation KitConformis, Inc.6556C009012021-04-30
M5726556C010011Triathlon AS-1 PS Box Ream CS Insert Cementless Instrumentation KitConformis, Inc.6556C010012021-04-30
M572RCR010000A011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000A012015-10-26
M572RCR010000A021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000A022015-10-26
M572RCR010000A031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000A032015-10-26
M572RCR010000B011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000B012015-10-26
M572RCR010000B021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000B022015-10-26
M572RCR010000B031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000B032015-10-26
M572RCR010000C011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000C012015-10-26
M572RCR010000C021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000C022015-10-26
M572RCR010000C031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000C032015-10-26
M572RCR010000D021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000D022015-10-26
M572RCR010000E021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000E022015-10-26
M572RCR010000F011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000F012015-10-26
M572RCR010000F021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000F022015-10-26
M572RCR010000F031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000F032015-10-26
M572RCR010000G011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000G012015-10-26
M572RCR010000G031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000G032015-10-26
M572RCR010000I021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000I022015-10-26
M572RCR010000I031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000I032015-10-26
M572RCR010000J021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000J022015-10-26
M572RCR010000J031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000J032015-10-26
M572RCR010000K021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000K022015-10-26
M572RCR010000K031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR010000K032015-10-26
M572RCR0100600011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0100600012015-10-26
M572RCR0100700031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0100700032015-10-26
M572RCR0100800011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0100800012015-10-26
M572RCR0100800031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0100800032015-10-26
M572RCR0100900011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0100900012015-10-26
M572RCR0100900031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0100900032015-10-26
M572RCR0101000011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101000012015-10-26
M572RCR0101000031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101000032015-10-26
M572RCR0101100011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101100012015-10-26
M572RCR0101100031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101100032015-10-26
M572RCR0101200021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101200022015-10-26
M572RCR0101200031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101200032015-10-26
M572RCR0101300011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101300012015-10-26
M572RCR0101300021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101300022015-10-26
M572RCR0101300031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101300032015-10-26
M572RCR0101400011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101400012015-10-26
M572RCR0101400021iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101400022015-10-26
M572RCR0101400031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101400032015-10-26
M572RCR0101500011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101500012015-10-26
M572RCR0101500031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101500032015-10-26
M572RCR0101600011iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101600012015-10-26
M572RCR0101600031iTotal® CR iPoly™ Insert KitConformis, Inc.RCR0101600032015-10-26
M572RPS0100600011iTotal® PS iPoly™ Insert KitConformis, Inc.RPS0100600012015-10-26
M572RPS0100600021iTotal® PSConformis, Inc.RPS0100600022016-10-24
M572RPS0100700011iTotal® PS iPoly™ Insert KitConformis, Inc.RPS0100700012015-10-26
M572RPS0100700021iTotal® PS Conformis, Inc.RPS0100700022016-10-24
M572RPS0100800011iTotal® PS iPoly™ Insert KitConformis, Inc.RPS0100800012015-10-26
M572RPS0100800021iTotal® PS Conformis, Inc.RPS0100800022016-10-24
M572RPS0100900011iTotal® PS iPoly™ Insert KitConformis, Inc.RPS0100900012015-10-26
M572RPS0100900021iTotal® PSConformis, Inc.RPS0100900022016-10-24
M572RPS0101000021iTotal® PSConformis, Inc.RPS0101000022016-10-24
M572RPS0101100021iTotal® PS Conformis, Inc.RPS0101100022016-10-24
M572RPS0101200011iTotal® PS iPoly™ Insert KitConformis, Inc.RPS0101200012015-10-26