FDA.reportPublic FDA data

Unicondylar knee prosthesis

Definition
A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.
GUDID devices
1,537
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190446294146DJO SURGICALEncore Medical, L.P.247-01-1012020-05-19
00190446294153DJO SURGICALEncore Medical, L.P.247-01-1022020-05-19
00190446294160DJO SURGICALEncore Medical, L.P.247-01-1032020-05-19
00190446294177DJO SURGICALEncore Medical, L.P.247-01-1042020-05-19
00190446294184DJO SURGICALEncore Medical, L.P.247-01-1052020-05-19
00190446294191DJO SURGICALEncore Medical, L.P.247-01-1062020-05-19
00190446294207DJO SURGICALEncore Medical, L.P.247-02-1012020-05-19
00190446294214DJO SURGICALEncore Medical, L.P.247-02-1022020-05-19
00190446294221DJO SURGICALEncore Medical, L.P.247-02-1032020-05-19
00190446294238DJO SURGICALEncore Medical, L.P.247-02-1042020-05-19
00190446294245DJO SURGICALEncore Medical, L.P.247-02-1052020-05-19
00190446294252DJO SURGICALEncore Medical, L.P.247-02-1062020-05-19
00811767027731FreedomMAXX ORTHOPEDICS, INC.3134212022-12-08
00811767027748FreedomMAXX ORTHOPEDICS, INC.3134712022-12-08
00811767027755FreedomMAXX ORTHOPEDICS, INC.3144212022-12-08
00811767027762FreedomMAXX ORTHOPEDICS, INC.3144712022-12-08
00811767027816FreedomMAXX ORTHOPEDICS, INC.3113462022-12-08
00811767027823FreedomMAXX ORTHOPEDICS, INC.3113472022-12-08
00811767027830FreedomMAXX ORTHOPEDICS, INC.3113482022-12-08
00811767027847FreedomMAXX ORTHOPEDICS, INC.3113862022-12-08
00811767027854FreedomMAXX ORTHOPEDICS, INC.3113872022-12-08
00811767027861FreedomMAXX ORTHOPEDICS, INC.3113882022-12-08
00811767027878FreedomMAXX ORTHOPEDICS, INC.3114262022-12-08
00811767027885FreedomMAXX ORTHOPEDICS, INC.3114272022-12-08
00811767027892FreedomMAXX ORTHOPEDICS, INC.3114282022-12-08
00888867231245Arthrex®ARTHREX, INC.AR-521-TBA02017-01-30
00888867231252Arthrex®ARTHREX, INC.AR-521-TBA12017-01-30
00888867231269Arthrex®ARTHREX, INC.AR-521-TBA22017-01-30
00888867231276Arthrex®ARTHREX, INC.AR-521-TBA42017-01-30
00888867231283Arthrex®ARTHREX, INC.AR-521-TBA82017-01-30
00888867231290Arthrex®ARTHREX, INC.AR-521-TBA92017-01-30
00888867231306Arthrex®ARTHREX, INC.AR-521-TBB02017-01-30
00888867231337Arthrex®ARTHREX, INC.AR-521-TBB12017-01-30
00888867231344Arthrex®ARTHREX, INC.AR-521-TBB22017-01-30
00888867231351Arthrex®ARTHREX, INC.AR-521-TBB42017-01-30
00888867231368Arthrex®ARTHREX, INC.AR-521-TBB82017-01-30
00888867231375Arthrex®ARTHREX, INC.AR-521-TBB92017-01-30
00888867233157Arthrex®ARTHREX, INC.AR-521-TBC02017-01-30
00888867233164Arthrex®ARTHREX, INC.AR-521-TBC12017-01-30
00888867233171Arthrex®ARTHREX, INC.AR-521-TBC22017-01-30
00888867233188Arthrex®ARTHREX, INC.AR-521-TBC42017-01-30
00888867233195Arthrex®ARTHREX, INC.AR-521-TBC82017-01-30
00888867233201Arthrex®ARTHREX, INC.AR-521-TBC92017-01-30
00888867233218Arthrex®ARTHREX, INC.AR-521-TBD02017-01-30
00888867233225Arthrex®ARTHREX, INC.AR-521-TBD12017-01-30
00888867233232Arthrex®ARTHREX, INC.AR-521-TBD22017-01-30
00888867233249Arthrex®ARTHREX, INC.AR-521-TBD42017-01-30
00888867233256Arthrex®ARTHREX, INC.AR-521-TBD82017-01-30
00888867233263Arthrex®ARTHREX, INC.AR-521-TBD92017-01-30
00888867233270Arthrex®ARTHREX, INC.AR-521-TBE02017-01-30
00888867233287Arthrex®ARTHREX, INC.AR-521-TBE12017-01-30
00888867233294Arthrex®ARTHREX, INC.AR-521-TBE22017-01-30
00888867233300Arthrex®ARTHREX, INC.AR-521-TBE42017-01-30
00888867233317Arthrex®ARTHREX, INC.AR-521-TBE82017-01-30
00888867233324Arthrex®ARTHREX, INC.AR-521-TBE92017-01-30
00888867233331Arthrex®ARTHREX, INC.AR-521-TBF02017-01-30
00888867233348Arthrex®ARTHREX, INC.AR-521-TBF12017-01-30
00888867233355Arthrex®ARTHREX, INC.AR-521-TBF22017-01-30
00888867233362Arthrex®ARTHREX, INC.AR-521-TBF42017-01-30
00888867233379Arthrex®ARTHREX, INC.AR-521-TBF82017-01-30
00888867233386Arthrex®ARTHREX, INC.AR-521-TBF92017-01-30
00889024683181Oxford® Partial Knee SystemBiomet Uk Ltd1122111002026-04-03
00889024683198Oxford® Partial Knee SystemBiomet Uk Ltd1122112002026-04-03
00889024683204Oxford® Partial Knee SystemBiomet Uk Ltd1122113002026-04-03
00889024683211Oxford® Partial Knee SystemBiomet Uk Ltd1122114002026-04-03
00889024683228Oxford® Partial Knee SystemBiomet Uk Ltd1122115002026-04-03
00889024683235Oxford® Partial Knee SystemBiomet Uk Ltd1122116002026-04-03
00889024683242Oxford® Partial Knee SystemBiomet Uk Ltd1122117002026-04-03
00889024683259Oxford® Partial Knee SystemBiomet Uk Ltd1122211002026-04-03
00889024683266Oxford® Partial Knee SystemBiomet Uk Ltd1122212002026-04-03
00889024683273Oxford® Partial Knee SystemBiomet Uk Ltd1122213002026-04-03
00889024683280Oxford® Partial Knee SystemBiomet Uk Ltd1122214002026-04-03
00889024683297Oxford® Partial Knee SystemBiomet Uk Ltd1122215002026-04-03
00889024683303Oxford® Partial Knee SystemBiomet Uk Ltd1122216002026-04-03
00889024683310Oxford® Partial Knee SystemBiomet Uk Ltd1122217002026-04-03
00889024683327Oxford® Partial Knee SystemBiomet Uk Ltd1123111002026-04-03
00889024683334Oxford® Partial Knee SystemBiomet Uk Ltd1123112002026-04-03
00889024683341Oxford® Partial Knee SystemBiomet Uk Ltd1123113002026-04-03
00889024683358Oxford® Partial Knee SystemBiomet Uk Ltd1123114002026-04-03
00889024683365Oxford® Partial Knee SystemBiomet Uk Ltd1123115002026-04-03