Product code JDL
- Device name
- Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Medical specialty
- Orthopedic
- Device class
- 3
- Regulation number
- 888.3320
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073499 | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | Zimmer, Inc. | 2008-08-07 |
| K070785 | DYNASTY ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | 2007-07-11 |
| K061844 | DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER | Wrightmedicaltechnologyinc | 2006-12-06 |
| K051995 | PROFEMUR RENAISSANCE HIP STEM | Wrightmedicaltechnologyinc | 2005-08-22 |
| K051348 | CONSERVE TOTAL FEMORAL HEAD | Wrightmedicaltechnologyinc | 2005-08-19 |
| K042841 | M2A/C2A ACETABULAR SYSTEM | Biomet, Inc. | 2004-12-21 |
| K041586 | PROFEMUR S HIP STEM | Wrightmedicaltechnologyinc | 2004-07-09 |
| K041114 | PROFEMUR TAPERED HIP STEM | Wrightmedicaltechnologyinc | 2004-05-28 |
| K004043 | METAL TRANSCEND ARTICULATION SYSTEM | Wrightmedicaltechnologyinc | 2001-07-13 |
| K950542 | METAL BACKED ACETABULAR COMPONENT | Encore Orthopedics, Inc. | 1995-05-25 |
| K944769 | P.F.C. APICAL PLUG | Johnson & Johnson Professionals, Inc. | 1994-12-08 |
| K942809 | ACETABULAR DOME HOLE PLUGS | Osteonics Corp. | 1994-09-20 |
| K931676 | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | Joint Medical Products Corp. | 1994-05-18 |
| K934440 | PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES | Howmedica Corp. | 1994-02-22 |
| K930833 | PCA(R) SOLID BACK ACETABULA SHELL | Howmedica Corp. | 1994-02-22 |
| K935669 | SYRIGENE PRE-FILLED SYRINGE | Regulatory & Marketing Services, Inc. | 1994-02-18 |
| K922561 | CONSENSUS(TM) TOTAL HIP SYSTEM | U.S. Medical Products, Inc. | 1993-07-21 |
| K915529 | FPC/SFPC/RFPC ACETABULAR COMPONENT | Implantology Corp. | 1993-07-13 |
| K915527 | CPS ACETABULAR COMPONENT | Implantology Corp. | 1993-06-24 |
| K922861 | BIOMETRIC SCREW FIXATION CUP | Osteo Technology, Inc. | 1993-05-12 |
| K920929 | POLY INSERT 20 DEGREE | Dow Corning Wright | 1993-05-05 |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Techmedica, Inc. | 1993-02-05 |
| K921139 | HEALEY REVISION COMPONENT SYSTEM | Biomet, Inc. | 1992-07-01 |
| K921384 | PCA ACETABULAR INSERT II | Howmedica Corp. | 1992-06-25 |
| K920868 | ACETABULAR DOME AND SCREW HOLE PLUGS | Osteonics Corp. | 1992-05-26 |
| K896614 | S.A.F. ACETABULAR CUP WITH POROUS COATING | Synergy Orthopaedics Intl., Inc. | 1990-01-09 |
| K894965 | POROUS-COATED TITANIUM ACETABULAR CUP | Dow Corning Wright | 1989-11-17 |
| K895607 | POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT | Exactech, Inc. | 1989-11-17 |
| K892640 | PNEUMOTHORAX KIT, MOTIFICATION | Arrow Intl., Inc. | 1989-10-11 |
| K870867 | KM-4(TM) METAL-BACKED ACETABULAR CUP | Kirschner Medical Corp. | 1987-05-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M684260000231 | TRANSCEND® | Microport Orthopedics Inc. | 2015-10-20 |
| M684260000221 | TRANSCEND® | Microport Orthopedics Inc. | 2015-10-20 |
| M684260000211 | TRANSCEND® | Microport Orthopedics Inc. | 2015-10-20 |
| M684260000201 | TRANSCEND® | Microport Orthopedics Inc. | 2015-10-20 |
| M684260000191 | TRANSCEND® | Microport Orthopedics Inc. | 2015-10-20 |
| M684260000181 | TRANSCEND® | Microport Orthopedics Inc. | 2015-10-20 |
| 07613327038118 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038200 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038194 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038187 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038163 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038156 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038149 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038125 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021400 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038101 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038088 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038064 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038033 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038026 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327038019 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327037951 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327037913 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327037869 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021547 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021479 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021462 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021431 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021424 | Omnifit | Howmedica Osteonics Corp. | 2015-09-24 |
| 10603295175995 | S-ROM | DEPUY ORTHOPAEDICS, INC. | 2014-09-20 |