FDA.reportPublic FDA data

Uncoated unicondylar knee tibia prosthesis, polyethylene

Definition
A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, and its implantation is intended to be performed with bone cement.
GUDID devices
530
Last updated
2026-06-13 06:05:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03596010589101JOURNEYSmith & Nephew, Inc.714222742015-08-30
03596010589132JOURNEYSmith & Nephew, Inc.714222772015-08-30
03596010589224JOURNEYSmith & Nephew, Inc.714222882015-08-30
03596010589309JOURNEYSmith & Nephew, Inc.714222982015-08-30
03596010589460JOURNEYSmith & Nephew, Inc.714223182015-08-30
03700386913204HLS UNI EVOLUTIONTORNIERGDU1122015-10-16
03700386913211HLS UNI EVOLUTIONTORNIERGDU1142015-10-16
03700386913228HLS UNI EVOLUTIONTORNIERGDU1162015-10-16
03700386913235HLS UNI EVOLUTIONTORNIERGDU1222015-10-16
03700386913242HLS UNI EVOLUTIONTORNIERGDU1242015-10-16
03700386913259HLS UNI EVOLUTIONTORNIERGDU1262015-10-16
03700386913266HLS UNI EVOLUTIONTORNIERGDU1322015-10-16
03700386913273HLS UNI EVOLUTIONTORNIERGDU1342015-10-16
03700386913280HLS UNI EVOLUTIONTORNIERGDU1362015-10-16
03700386913297HLS UNI EVOLUTIONTORNIERGDU1422015-10-16
03700386913303HLS UNI EVOLUTIONTORNIERGDU1442015-10-16
03700386913310HLS UNI EVOLUTIONTORNIERGDU1462015-10-16
03700386913327HLS UNI EVOLUTIONTORNIERGDU1522015-10-16
03700386913334HLS UNI EVOLUTIONTORNIERGDU1542015-10-16
03700386913341HLS UNI EVOLUTIONTORNIERGDU1562015-10-16
10885862065902Optetrak UnicondylarExactech, Inc.252-22-042015-10-30
10885862065919Optetrak UnicondylarExactech, Inc.252-22-052015-10-30
10885862065926Optetrak UnicondylarExactech, Inc.252-22-062015-10-30
10885862065933Optetrak UnicondylarExactech, Inc.252-23-012015-10-30
10885862065940Optetrak UnicondylarExactech, Inc.252-23-022015-10-30
10885862065957Optetrak UnicondylarExactech, Inc.252-23-032015-10-30
00850011453339REMEDY Poly+Plus Tibial Spacer OSTEOREMEDIES, LLCRPPSM132025-12-16
00850011453346REMEDY Poly+Plus Tibial Spacer OSTEOREMEDIES, LLCRPPSM172025-12-16
00850011453353REMEDY Poly+Plus Tibial Spacer OSTEOREMEDIES, LLCRPPMD132025-12-16
00850011453360REMEDY Poly+Plus Tibial Spacer OSTEOREMEDIES, LLCRPPMD172025-12-16
00850011453377REMEDY Poly+Plus Tibial Spacer OSTEOREMEDIES, LLCRPPLG132025-12-16
00850011453384REMEDY Poly+Plus Tibial Spacer OSTEOREMEDIES, LLCRPPLG172025-12-16
04026575268559LINK Endo-Model EVO Knee SystemWALDEMAR LINK GmbH & Co. KG15-2716/052023-01-26
10885862065759Optetrak UnicondylarExactech, Inc.252-12-012015-10-30
10885862065766Optetrak UnicondylarExactech, Inc.252-12-022015-10-30
10885862065773Optetrak UnicondylarExactech, Inc.252-12-032015-10-30
10885862065780Optetrak UnicondylarExactech, Inc.252-12-042015-10-30
10885862065797Optetrak UnicondylarExactech, Inc.252-12-052015-10-30
10885862065803Optetrak UnicondylarExactech, Inc.252-12-062015-10-30
10885862065810Optetrak UnicondylarExactech, Inc.252-13-012015-10-30
10885862065827Optetrak UnicondylarExactech, Inc.252-13-022015-10-30
10885862065834Optetrak UnicondylarExactech, Inc.252-13-032015-10-30
10885862065841Optetrak UnicondylarExactech, Inc.252-13-042015-10-30
10885862065858Optetrak UnicondylarExactech, Inc.252-13-052015-10-30
10885862065865Optetrak UnicondylarExactech, Inc.252-13-062015-10-30
10885862065872Optetrak UnicondylarExactech, Inc.252-22-012015-10-30
10885862065889Optetrak UnicondylarExactech, Inc.252-22-022015-10-30
10885862065896Optetrak UnicondylarExactech, Inc.252-22-032015-10-30
10885862065964Optetrak UnicondylarExactech, Inc.252-23-042015-10-30
10885862065971Optetrak UnicondylarExactech, Inc.252-23-052015-10-30
10885862065988Optetrak UnicondylarExactech, Inc.252-23-062015-10-30
10603295001836SIGMADEPUY (IRELAND)1024-11-1082015-09-24
10603295001911SIGMADEPUY (IRELAND)1024-11-3082015-09-24
10603295002192SIGMADEPUY (IRELAND)1024-12-4082015-09-24
10603295001843SIGMADEPUY (IRELAND)1024-11-1092015-09-24
10603295001850SIGMADEPUY (IRELAND)1024-11-1102015-09-24
10603295001867SIGMADEPUY (IRELAND)1024-11-1112015-09-24
10603295001874SIGMADEPUY (IRELAND)1024-11-2082015-09-24
10603295001881SIGMADEPUY (IRELAND)1024-11-2092015-09-24
10603295001898SIGMADEPUY (IRELAND)1024-11-2102015-09-24
10603295001904SIGMADEPUY (IRELAND)1024-11-2112015-09-24
10603295001928SIGMADEPUY (IRELAND)1024-11-3092015-09-24
10603295001935SIGMADEPUY (IRELAND)1024-11-3102015-09-24
10603295001942SIGMADEPUY (IRELAND)1024-11-3112015-09-24
10603295001959SIGMADEPUY (IRELAND)1024-11-4082015-09-24
10603295001966SIGMADEPUY (IRELAND)1024-11-4092015-09-24
10603295001973SIGMADEPUY (IRELAND)1024-11-4102015-09-24
10603295001980SIGMADEPUY (IRELAND)1024-11-4112015-09-24
10603295001997SIGMADEPUY (IRELAND)1024-11-5082015-09-24
10603295002000SIGMADEPUY (IRELAND)1024-11-5092015-09-24
10603295002017SIGMADEPUY (IRELAND)1024-11-5102015-09-24
10603295002024SIGMADEPUY (IRELAND)1024-11-5112015-09-24
10603295002031SIGMADEPUY (IRELAND)1024-11-6082015-09-24
10603295002048SIGMADEPUY (IRELAND)1024-11-6092015-09-24
10603295002055SIGMADEPUY (IRELAND)1024-11-6102015-09-24
10603295002062SIGMADEPUY (IRELAND)1024-11-6112015-09-24
10603295002079SIGMADEPUY (IRELAND)1024-12-1082015-09-24
10603295002086SIGMADEPUY (IRELAND)1024-12-1092015-09-24
10603295002093SIGMADEPUY (IRELAND)1024-12-1102015-09-24
10603295002109SIGMADEPUY (IRELAND)1024-12-1112015-09-24