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.
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| 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 |
Top Applicants
- Wrightmedicaltechnologyinc — 7 clearances
- Howmedica Corp. — 5 clearances
- Kirschner Medical Corp. — 3 clearances
- Osteonics Corp. — 3 clearances
- Advanced Biosearch Assn. — 2 clearances
