JDG · Prosthesis, Hip, Femoral Component, Cemented, Metal
Orthopedic · 21 CFR 888.3360 · Class 2
Overview
| Product Code | JDG |
|---|---|
| Device Name | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | Biomet, Inc. | Feb 7, 2022 | SESE |
| K193546 | Distal Centralizers | Biomet, Inc. | Sep 25, 2020 | SESE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | Mar 19, 2018 | SESE |
| K001984 | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT | Stelkast Company | Sep 27, 2000 | SESE |
| K992234 | THE TAPER-FIT TOTAL HIP SYSTEM | Corin USA | Nov 10, 1999 | SESE |
| K962002 | AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM | Exactech, Inc. | Aug 8, 1996 | SESE |
| K955171 | NEXLOCK FEMORAL STEM | Nexmed, Inc. | Feb 9, 1996 | SESE |
| K953653 | LUBINUS SP II HIP SYSTEM | Turnkey Intergration USA, Inc. | Nov 6, 1995 | SESE |
| K953067 | HIP FRACTURE STEM FENESTRATION PLUG | Howmedica Corp. | Aug 21, 1995 | SESE |
| K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM | Orthomet, Inc. | May 30, 1995 | SESE |
| K951083 | PROFORM CEMENTED FEMORAL COMPONENT | Stelkast Company | May 22, 1995 | SN |
| K942479 | INTEGRAL CO-CR FEMORAL COMPONENT | Biomet, Inc. | Sep 20, 1994 | SESE |
| K942028 | RX90 FEMORAL COMPONENT | Biomet, Inc. | Sep 19, 1994 | SN |
| K942027 | IMPACT CO-CR 1-PIECE FEMORAL COMPONENT | Biomet, Inc. | Sep 19, 1994 | SN |
| K931194 | CO-CR ANSWER FEMORAL COMPONENT | Biomet, Inc. | May 5, 1994 | SESE |
| K935078 | S-ROM TOTAL HIP REPLACEMENT SYSTEM | Joint Medical Products Corp. | Mar 9, 1994 | SN |
| K933871 | BRIDGE(TM) HIP SYSTEM | Wrightmedicaltechnologyinc | Feb 23, 1994 | SN |
| K915385 | PPC HIP STEM COMPONENT | Implantology Corp. | May 17, 1993 | SN |
| K924099 | UFC HIP STEM COMPONENT | Implantology Corp. | Apr 30, 1993 | SESE |
| K915391 | FPC HIP STEM COMPONENT | Implantology Corp. | Apr 30, 1993 | SESE |
Top Applicants
- Howmedica Corp. — 7 clearances
- Biomet, Inc. — 7 clearances
- Orthopedic Equipment Co., Inc. — 6 clearances
- Depuy, Inc. — 5 clearances
- Hexcel Medical — 4 clearances
