FDA.reportPublic FDA data

Wrist ulna-head prosthesis

Definition
A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
GUDID devices
151
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B013DRUJRPLP200Scheker ProsthesisAPTIS MEDICAL, LLCDRUJ-RPLP202019-05-14
B013DRUJRPLP300Scheker ProsthesisAPTIS MEDICAL, LLCDRUJ-RPLP302019-05-14
00885556821688BioMotion Cannulated 1st MPJ Hemi SystemSmith & Nephew, Inc.HM15002022-12-21
00885556821695BioMotion Cannulated 1st MPJ Hemi SystemSmith & Nephew, Inc.HM17002022-12-21
00885556821701BioMotion Cannulated 1st MPJ Hemi SystemSmith & Nephew, Inc.HM19002022-12-21
00885556821718BioMotion Cannulated 1st MPJ Hemi SystemSmith & Nephew, Inc.HM21002022-12-21
00885556821725BioMotion Cannulated 1st MPJ Hemi SystemSmith & Nephew, Inc.HM23002022-12-21
00885556826492First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1645-WW2022-12-21
00885556826508First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1655-WW2022-12-21
00885556826515First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1665-WW2022-12-21
00885556826522First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1745-WW2022-12-21
00885556826539First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1755-WW2022-12-21
00885556826546First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1765-WW2022-12-21
00885556826553First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1945-WW2022-12-21
00885556826560First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1955-WW2022-12-21
00885556826577First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.DRUJ-610-1965-WW2022-12-21
00885556826195First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-H160-WW2022-12-21
00885556826201First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-H175-WW2022-12-21
00885556826218First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-H190-WW2022-12-21
00885556826225First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S45L-WW2022-12-21
00885556826232First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S45M-WW2022-12-21
00885556826249First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S45S-WW2022-12-21
00885556826256First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S55L-WW2022-12-21
00885556826263First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S55M-WW2022-12-21
00885556826270First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S55S-WW2022-12-21
00885556826287First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S65L-WW2022-12-21
00885556826294First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S65M-WW2022-12-21
00885556826300First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.MUH-600-S65S-WW2022-12-21
10381780123545Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101445WW2017-10-09
10381780123552Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101455WW2017-10-09
10381780123569Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101465WW2017-10-09
10381780123576Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101645WW2017-10-09
10381780123583Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101655WW2017-10-09
10381780123590Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101665WW2017-10-09
10381780123606Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101745WW2017-10-09
10381780123613Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101755WW2017-10-09
10381780123620Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101765WW2017-10-09
10381780123637Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101945WW2017-10-09
10381780123644Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101955WW2017-10-09
10381780123651Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.DRUJ6101965WW2017-10-09
B013DRUJB10200NAAPTIS MEDICAL, LLCDRUJ-B10202021-08-27
B013DRUJB200NAAPTIS MEDICAL, LLCDRUJ-B202021-08-27
B013DRUJB300NAAPTIS MEDICAL, LLCDRUJ-B302021-08-27
B013DRUJIS0450NAAPTIS MEDICAL, LLCDRUJ-IS0452021-08-27
B013DRUJIS0500NAAPTIS MEDICAL, LLCDRUJ-IS0502021-08-27
B013DRUJIS1400NAAPTIS MEDICAL, LLCDRUJ-IS1402021-08-27
B013DRUJIS1450NAAPTIS MEDICAL, LLCDRUJ-IS1452021-08-27
B013DRUJIS1500NAAPTIS MEDICAL, LLCDRUJ-IS1502021-08-27
B013DRUJIS1600NAAPTIS MEDICAL, LLCDRUJ-IS1602021-08-27
B013DRUJIS2400NAAPTIS MEDICAL, LLCDRUJ-IS2402021-08-27
B013DRUJIS2450NAAPTIS MEDICAL, LLCDRUJ-IS2452021-08-27
B013DRUJIS2500NAAPTIS MEDICAL, LLCDRUJ-IS2502021-08-27
B013DRUJIS2600NAAPTIS MEDICAL, LLCDRUJ-IS2602021-08-27
B013DRUJIS3400NAAPTIS MEDICAL, LLCDRUJ-IS3402021-08-27
B013DRUJIS3450NAAPTIS MEDICAL, LLCDRUJ-IS3452021-08-27
B013DRUJIS3500NAAPTIS MEDICAL, LLCDRUJ-IS3502021-08-27
B013DRUJIS3600NAAPTIS MEDICAL, LLCDRUJ-IS3602021-08-27
B013DRUJIS4400NAAPTIS MEDICAL, LLCDRUJ-IS4402021-08-27
B013DRUJIS4450NAAPTIS MEDICAL, LLCDRUJ-IS4452021-08-27
B013DRUJIS4500NAAPTIS MEDICAL, LLCDRUJ-IS4502021-08-27
B013DRUJIS4600NAAPTIS MEDICAL, LLCDRUJ-IS4602021-08-27
B013DRUJLP100NAAPTIS MEDICAL, LLCDRUJ-LP102021-08-27
B013DRUJLP200NAAPTIS MEDICAL, LLCDRUJ-LP202021-08-27
B013DRUJP200NAAPTIS MEDICAL, LLCDRUJ-P202021-08-27
B013DRUJP300NAAPTIS MEDICAL, LLCDRUJ-P302021-08-27
B013DRUJRPCS1000NAAPTIS MEDICAL, LLCDRUJ-RPCS1002021-08-27
B013DRUJRPLP100NAAPTIS MEDICAL, LLCDRUJ-RPLP102021-08-27
10381780120667Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600H160WW2017-10-09
10381780120674Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600H175WW2017-10-09
10381780120681Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600H190WW2017-10-09
10381780120698Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S45LWW2017-10-09
10381780120704Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S45MWW2017-10-09
10381780120711Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S45SWW2017-10-09
10381780120728Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S55LWW2017-10-09
10381780120735Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S55MWW2017-10-09
10381780120742Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S55SWW2017-10-09
10381780120759Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S65LWW2017-10-09
10381780120766Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S65MWW2017-10-09
10381780120773Ascension® First Choice® DRUJ SystemAscension Orthopedics, Inc.MUH600S65SWW2017-10-09
B013DRUJB1020NAAPTIS MEDICAL, LLCDRUJ-B10202015-07-08