JDL · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Orthopedic · 21 CFR 888.3320 · Class 3
Overview
| Product Code | JDL |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
| Regulation | 21 CFR 888.3320 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (45)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073499 | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | Zimmer, Inc. | Aug 7, 2008 | SESE |
| K070785 | DYNASTY ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | Jul 11, 2007 | SESE |
| K061844 | DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER | Wrightmedicaltechnologyinc | Dec 6, 2006 | SESE |
| K051995 | PROFEMUR RENAISSANCE HIP STEM | Wrightmedicaltechnologyinc | Aug 22, 2005 | SESE |
| K051348 | CONSERVE TOTAL FEMORAL HEAD | Wrightmedicaltechnologyinc | Aug 19, 2005 | SESE |
| K042841 | M2A/C2A ACETABULAR SYSTEM | Biomet, Inc. | Dec 21, 2004 | SESE |
| K041586 | PROFEMUR S HIP STEM | Wrightmedicaltechnologyinc | Jul 9, 2004 | SESE |
| K041114 | PROFEMUR TAPERED HIP STEM | Wrightmedicaltechnologyinc | May 28, 2004 | SESE |
| K004043 | METAL TRANSCEND ARTICULATION SYSTEM | Wrightmedicaltechnologyinc | Jul 13, 2001 | SESE |
| K950542 | METAL BACKED ACETABULAR COMPONENT | Encore Orthopedics, Inc. | May 25, 1995 | SESE |
| K944769 | P.F.C. APICAL PLUG | Johnson & Johnson Professionals, Inc. | Dec 8, 1994 | SESE |
| K942809 | ACETABULAR DOME HOLE PLUGS | Osteonics Corp. | Sep 20, 1994 | SESE |
| K931676 | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | Joint Medical Products Corp. | May 18, 1994 | SESE |
| K934440 | PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES | Howmedica Corp. | Feb 22, 1994 | SESE |
| K930833 | PCA(R) SOLID BACK ACETABULA SHELL | Howmedica Corp. | Feb 22, 1994 | SESE |
| K935669 | SYRIGENE PRE-FILLED SYRINGE | Regulatory & Marketing Services, Inc. | Feb 18, 1994 | SESE |
| K922561 | CONSENSUS(TM) TOTAL HIP SYSTEM | U.S. Medical Products, Inc. | Jul 21, 1993 | SESE |
| K915529 | FPC/SFPC/RFPC ACETABULAR COMPONENT | Implantology Corp. | Jul 13, 1993 | SESE |
| K915527 | CPS ACETABULAR COMPONENT | Implantology Corp. | Jun 24, 1993 | SESE |
| K922861 | BIOMETRIC SCREW FIXATION CUP | Osteo Technology, Inc. | May 12, 1993 | SESE |
| K920929 | POLY INSERT 20 DEGREE | Dow Corning Wright | May 5, 1993 | SESE |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Techmedica, Inc. | Feb 5, 1993 | SESE |
| K921139 | HEALEY REVISION COMPONENT SYSTEM | Biomet, Inc. | Jul 1, 1992 | SESE |
| K921384 | PCA ACETABULAR INSERT II | Howmedica Corp. | Jun 25, 1992 | SESE |
| K920868 | ACETABULAR DOME AND SCREW HOLE PLUGS | Osteonics Corp. | May 26, 1992 | SESE |
| K896614 | S.A.F. ACETABULAR CUP WITH POROUS COATING | Synergy Orthopaedics Intl., Inc. | Jan 9, 1990 | SN |
| K895607 | POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT | Exactech, Inc. | Nov 17, 1989 | SN |
| K894965 | POROUS-COATED TITANIUM ACETABULAR CUP | Dow Corning Wright | Nov 17, 1989 | SN |
| K892640 | PNEUMOTHORAX KIT, MOTIFICATION | Arrow Intl., Inc. | Oct 11, 1989 | SESE |
| K870867 | KM-4(TM) METAL-BACKED ACETABULAR CUP | Kirschner Medical Corp. | May 8, 1987 | SESE |
| K870234 | P.T.H. METAL-BACKED ACETABULAR CUP | Orthopaedic Device Corp. | Mar 20, 1987 | SESE |
| K861264 | JOINT MEASUREMENT INDICATOR | Devcom, Inc. | Apr 15, 1986 | SESE |
| K855042 | KM-3 ACETABULAR COMPONENT | Kirschner Medical Corp. | Mar 14, 1986 | SN |
| K854107 | DIMENSION TOTAL HIP PROSTHESIS POROUS COATED | Kirschner Medical Corp. | Mar 10, 1986 | SN |
| K854935 | LINK METAL-BACKED ACETABULAR CUPS | Link America, Inc. | Mar 5, 1986 | SESE |
| K852369 | LIDGRER-LUND ACETABULAR SOCKETS | Link America, Inc. | Jun 18, 1985 | SESE |
| K850793 | MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA | Intermedics Orthopedics | May 9, 1985 | SESE |
| K850352 | MICRO-STRUC. ACETABULAR COMPON- MC2P | Osteonics Corp. | Apr 25, 1985 | SESE |
| K844482 | MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT | Advanced Biosearch Assn. | Feb 19, 1985 | SESE |
| K842893 | DORR HIP PROSTHESIS, ACETABULAR COMPON | Carbomedics, Inc. | Nov 8, 1984 | SESE |
| K831792 | SELF-ALIGNING ACETABULAR COMPONENT | Endomedics, Inc. | Sep 20, 1984 | SESE |
| K830662 | NATURAL LOCK ACETABULAR COMPONENT | Advanced Biosearch Assn. | Apr 11, 1983 | SESE |
| K813599 | 101-32 FEMORAL COMPONENT | Intermedics Orthopedics | Jan 22, 1982 | SESE |
| K790274 | BG PROXIMAL FEMUR | Howmedica Corp. | Mar 26, 1979 | SESE |
| K770472 | PROSTHESIS, VIDAL TOTAL HIP | Howmedica Corp. | Mar 17, 1977 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 7 clearances
- Howmedica Corp. — 5 clearances
- Osteonics Corp. — 3 clearances
- Kirschner Medical Corp. — 3 clearances
- Link America, Inc. — 2 clearances
