Product code JDG
- Device name
- Prosthesis, Hip, Femoral Component, Cemented, Metal
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3360
- 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 |
|---|---|---|---|
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | Biomet, Inc. | 2022-02-07 |
| K193546 | Distal Centralizers | Biomet, Inc. | 2020-09-25 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018-03-19 |
| K001984 | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT | Stelkast Company | 2000-09-27 |
| K992234 | THE TAPER-FIT TOTAL HIP SYSTEM | Corin USA | 1999-11-10 |
| K962002 | AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM | Exactech, Inc. | 1996-08-08 |
| K955171 | NEXLOCK FEMORAL STEM | Nexmed, Inc. | 1996-02-09 |
| K953653 | LUBINUS SP II HIP SYSTEM | Turnkey Intergration USA, Inc. | 1995-11-06 |
| K953067 | HIP FRACTURE STEM FENESTRATION PLUG | Howmedica Corp. | 1995-08-21 |
| K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM | Orthomet, Inc. | 1995-05-30 |
| K951083 | PROFORM CEMENTED FEMORAL COMPONENT | Stelkast Company | 1995-05-22 |
| K942479 | INTEGRAL CO-CR FEMORAL COMPONENT | Biomet, Inc. | 1994-09-20 |
| K942028 | RX90 FEMORAL COMPONENT | Biomet, Inc. | 1994-09-19 |
| K942027 | IMPACT CO-CR 1-PIECE FEMORAL COMPONENT | Biomet, Inc. | 1994-09-19 |
| K931194 | CO-CR ANSWER FEMORAL COMPONENT | Biomet, Inc. | 1994-05-05 |
| K935078 | S-ROM TOTAL HIP REPLACEMENT SYSTEM | Joint Medical Products Corp. | 1994-03-09 |
| K933871 | BRIDGE(TM) HIP SYSTEM | Wrightmedicaltechnologyinc | 1994-02-23 |
| K915385 | PPC HIP STEM COMPONENT | Implantology Corp. | 1993-05-17 |
| K924099 | UFC HIP STEM COMPONENT | Implantology Corp. | 1993-04-30 |
| K915391 | FPC HIP STEM COMPONENT | Implantology Corp. | 1993-04-30 |
| K915787 | STABILITY HIP STEM WITH POROCOAT | Depuy, Inc. | 1993-04-29 |
| K922682 | AMERICANA HIP PROTHESIS | Osteo Technology, Inc. | 1993-03-16 |
| K911595 | INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE | Dow Corning Wright | 1991-07-12 |
| K874868 | OPTI-FIX COLLARED FEMORAL COMPONENTS | Richards Medical Co., Inc. | 1988-01-26 |
| K874575 | PROXIMAL FEMORAL REPLACEMENT PROSTHESIS | Dow Corning Wright | 1988-01-07 |
| K874100 | AML CALCAR FEMORAL PROSTHESIS | Depuy, Inc. | 1987-12-31 |
| K873627 | CTI STRAIGHT STEM | Orthopedic Systems, Inc. | 1987-12-30 |
| K874740 | WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO | Dow Corning Wright | 1987-12-18 |
| K874617 | THOMPSON HIP PROSTHESIS | Orthopedic Systems, Inc. | 1987-12-10 |
| K873458 | HOWMEDICA PCA COLLARED FEMORAL STEM | Howmedica Corp. | 1987-09-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327123852 | V40 | Howmedica Osteonics Corp. | 2018-06-13 |
| 07613327123876 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327124057 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327124040 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327124026 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327124019 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327124002 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123982 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123975 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123968 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123951 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123937 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123920 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123913 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123906 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123890 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123869 | INSTRUMENT | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123845 | EXETER | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123791 | EXETER | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123777 | EXETER | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123753 | EXETER | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123746 | EXETER | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327123739 | EXETER | Howmedica Osteonics Corp. | 2018-05-03 |
| 07613327035773 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327035841 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327035834 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327035827 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327035810 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327035803 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327035797 | Centralizer | Howmedica Osteonics Corp. | 2015-09-24 |