FDA.reportPublic FDA data

Ceramic-on-polyethylene total hip prosthesis

Definition
A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
GUDID devices
453
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04547898491160BIOCERAM AZUL HEADKYOCERA CORPORATIONGMH04-4000512025-01-29
04547898491177BIOCERAM AZUL HEADKYOCERA CORPORATIONGMH04-4000522025-01-29
04547898491184BIOCERAM AZUL HEADKYOCERA CORPORATIONGMH04-4000532025-01-29
04547898491191BIOCERAM AZUL HEADKYOCERA CORPORATIONGMH04-4000542025-01-29
04547898491207BIOCERAM AZUL HEADKYOCERA CORPORATIONGMH04-4000602025-01-29
M209190230HEAD FEMORAL CERAMIC 28mm -3BIOPRO, INC.190232015-09-16
M209190240HEAD FEMORAL CERAMIC 28mm +0BIOPRO, INC.190242015-09-16
M209190250HEAD FEMORAL CERAMIC 32mm -3BIOPRO, INC.190252015-09-16
M209190260HEAD FEMORAL CERAMIC 32mm +0BIOPRO, INC.190262015-09-16
M209190270HEAD FEMORAL CERAMIC 32mm +3BIOPRO, INC.190272015-09-16
04580810059420BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000512026-02-27
04580810059437BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000522026-02-27
04580810059444BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000532026-02-27
04580810059451BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000542026-02-27
04580810059499BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000602026-02-27
04580810059475BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000572026-02-16
04580810059505BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000612026-02-16
04580810059512BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000622026-02-16
04580810059529BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000632026-02-16
04580810059543BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000652026-02-16
04580810059567BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000672026-02-16
04580810059581BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000712026-02-16
04580810059598BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000722026-02-16
04580810059611BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000742026-02-16
04580810059628BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000762026-02-16
04580810059635BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000772026-02-16
04580810059642BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000782026-02-16
04580810059659BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000792026-02-16
04580810059468BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000562026-02-11
04580810059536BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000642025-12-05
04580810059550BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000662025-12-05
04580810059574BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000682025-12-05
04580810059604BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000732025-12-05
04580810059482BIOCERAM AZUL HEADKYOCERA MEDICAL CORPORATIONGMH04-4000582025-12-02
00814193025760SYNOVO HIP COMPONENTSSynovo Production01-01-05462024-03-04
00814193025777SYNOVO HIP COMPONENTSSynovo Production01-01-05482024-03-04
00814193025784SYNOVO HIP COMPONENTSSynovo Production01-01-05502024-03-04
00814193025791SYNOVO HIP COMPONENTSSynovo Production01-01-05522024-03-04
00814193025807SYNOVO HIP COMPONENTSSynovo Production01-01-05542024-03-04
00814193025814SYNOVO HIP COMPONENTSSynovo Production01-01-05562024-03-04
00814193025821SYNOVO HIP COMPONENTSSynovo Production01-01-05582024-03-04
00814193025838SYNOVO HIP COMPONENTSSynovo Production01-01-05602024-03-04
00814193025845SYNOVO HIP COMPONENTSSynovo Production01-01-05622024-03-04
00814193025852SYNOVO HIP COMPONENTSSynovo Production01-01-05642024-03-04
00814193025869SYNOVO HIP COMPONENTSSynovo Production01-01-05662024-03-04
00814193025876SYNOVO HIP COMPONENTSSynovo Production01-01-05682024-03-04
00814193025883SYNOVO HIP COMPONENTSSynovo Production01-01-05702024-03-04
00814193025890SYNOVO HIP COMPONENTSSynovo Production01-02-41522024-03-04
00814193025906SYNOVO HIP COMPONENTSSynovo Production01-02-42542024-03-04
00814193025913SYNOVO HIP COMPONENTSSynovo Production01-02-44562024-03-04
00814193025920SYNOVO HIP COMPONENTSSynovo Production01-02-45582024-03-04
00814193025937SYNOVO HIP COMPONENTSSynovo Production01-02-47602024-03-04
00814193025944SYNOVO HIP COMPONENTSSynovo Production01-02-51642024-03-04
00814193025951SYNOVO HIP COMPONENTSSynovo Production01-02-52662024-03-04
00814193025968SYNOVO HIP COMPONENTSSynovo Production01-02-49622024-03-04
B565M132528031STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132532011STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132532021STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132532031STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132532041STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132536011STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132536021STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M132536031Tibial Revision PlatformCPM Medical Consultants, LLCRev A2022-02-15
B565M132536041STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M133528001STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M133532001STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M133536001STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220046281STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220050281STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220050321STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220052281STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220052321STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220054281STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220054361STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220058281STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220058321STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220058401STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220062281STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220062321STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15
B565M220062401STERIZO Total Hip SystemCPM Medical Consultants, LLCRev A2022-02-15