FDA.reportPublic FDA data

Total temporomandibular joint prosthesis

Definition
A sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included.
GUDID devices
74
Last updated
2026-07-30 21:31:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B004TYYNNNNLF0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.TYY-NNNNLF2017-01-27
B004TYYNNNNLM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.TYY-NNNNLM2017-01-27
B004TYYNNNNRF0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.TYY-NNNNRF2017-01-27
B004TYYNNNNRM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.TYY-NNNNRM2017-01-27
B004YYMMDDNNNNLF0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.YYMMDDNNNNLF2021-11-10
B004YYMMDDNNNNLM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.YYMMDDNNNNLM2021-11-10
B004YYMMDDNNNNRF0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.YYMMDDNNNNRF2021-11-10
B004YYMMDDNNNNRM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.YYMMDDNNNNRM2021-11-10
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.CHG0102023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.CHG0262023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.CHG0202023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.CHG0242023-09-11
10885632490767HalyardOWENS & MINOR DISTRIBUTION, INC.RSP1503P2026-01-29
20885632490764HalyardOWENS & MINOR DISTRIBUTION, INC.RSP1503P2026-01-29
07613327626650Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20062023-09-11
07613327626674Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20122023-09-11
07613327626681Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20052023-09-11
07613327626698Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20082023-09-11
07613327626704Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20162023-09-11
07613327626711Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20062023-09-11
07613327626728Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20082023-09-11
07613327626742Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20102023-09-11
07613327626759Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20162023-09-11
07613327626766Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20122023-09-11
07613327626773Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20052023-09-11
07613327626780Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20142023-09-11
07613327626797Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-20102023-09-11
07613327626803Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-23102023-09-11
07613327626810Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-23142023-09-11
07613327626827Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-23082023-09-11
07613327626834Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-23162023-09-11
07613327626841Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-23062023-09-11
07613327626858Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-23122023-09-11
07613327626865Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-23102023-09-11
07613327626872Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-23162023-09-11
07613327626889Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-23122023-09-11
07613327626896Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-23062023-09-11
07613327626902Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-23142023-09-11
07613327626919Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.65-23082023-09-11
07613327626926Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.61-20142023-09-11
00841036011857TMJ SYSTEMBIOMET MICROFIXATION, INC01-65452014-09-17
00841036011871TMJ SYSTEMBIOMET MICROFIXATION, INC01-65462014-09-17
00841036011895TMJ SYSTEMBIOMET MICROFIXATION, INC01-65502014-09-17
00841036036430TMJ SYSTEMBIOMET MICROFIXATION, INC24-65452014-09-17
00841036036454TMJ SYSTEMBIOMET MICROFIXATION, INC24-65462014-09-17
00841036036508TMJ SYSTEMBIOMET MICROFIXATION, INC24-65562014-09-17
00841036036522TMJ SYSTEMBIOMET MICROFIXATION, INC24-65602014-09-17
00841036036546TMJ SYSTEMBIOMET MICROFIXATION, INC24-65612014-09-17
00841036036560TMJ SYSTEMBIOMET MICROFIXATION, INC24-65622014-09-17
00841036036584TMJ SYSTEMBIOMET MICROFIXATION, INC24-65632014-09-17
00841036036607TMJ SYSTEMBIOMET MICROFIXATION, INC24-65642014-09-17
00841036036621TMJ SYSTEMBIOMET MICROFIXATION, INC24-65652014-09-17
00841036060329TMJ SYSTEMBIOMET MICROFIXATION, INC24-65512014-09-17
00841036060343TMJ SYSTEMBIOMET MICROFIXATION, INC24-65502014-09-17
00841036060398TMJ SYSTEMBIOMET MICROFIXATION, INC24-65552014-09-17
00841036060428TMJ SYSTEMBIOMET MICROFIXATION, INC01-65512014-09-17
00841036063580TMJ SYSTEMBIOMET MICROFIXATION, INC24-66502014-09-17
00841036064884TMJ SYSTEMBIOMET MICROFIXATION, INC24-66512014-09-17
00841036075118TMJ SYSTEMBIOMET MICROFIXATION, INC24-6545TI2014-09-17
00841036081348TMJ SYSTEMBIOMET MICROFIXATION, INC24-6555TI2014-09-17
00841036081386TMJ SYSTEMBIOMET MICROFIXATION, INC01-6545TI2014-09-17
00841036081553TMJ SYSTEMBIOMET MICROFIXATION, INC24-66452014-09-17
00841036081560TMJ SYSTEMBIOMET MICROFIXATION, INC24-66462014-09-17
00841036081713TMJ SYSTEMBIOMET MICROFIXATION, INC24-6546TI2014-09-17
00841036081720TMJ SYSTEMBIOMET MICROFIXATION, INC24-6550TI2014-09-17
00841036081737TMJ SYSTEMBIOMET MICROFIXATION, INC24-6551TI2014-09-17
00841036081744TMJ SYSTEMBIOMET MICROFIXATION, INC24-6556TI2014-09-17
00841036081782TMJ SYSTEMBIOMET MICROFIXATION, INC01-6546TI2014-09-17
00841036081799TMJ SYSTEMBIOMET MICROFIXATION, INC01-6550TI2014-09-17
00841036081805TMJ SYSTEMBIOMET MICROFIXATION, INC01-6551TI2014-09-17
00841036081867TMJ SYSTEMBIOMET MICROFIXATION, INC24-6645TI2014-09-17
00841036081874TMJ SYSTEMBIOMET MICROFIXATION, INC24-6646TI2014-09-17
00841036081881TMJ SYSTEMBIOMET MICROFIXATION, INC24-6650TI2014-09-17
00841036081898TMJ SYSTEMBIOMET MICROFIXATION, INC24-6651TI2014-09-17