LZY · Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Orthopedic · 21 CFR 888.3360 · Class 2
Overview
| Product Code | LZY |
|---|---|
| Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| 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.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | Jul 19, 2023 | SESE |
| K111145 | ENDO HEAD | Medacta International | Aug 16, 2011 | SESE |
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Latexindo Tobaperkasa | Jan 5, 1998 | SESE |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Implantology Corp. | Jun 29, 1993 | SESE |
| K915548 | IONGUARD TITANIUM MODULAR HEADS | Biomet, Inc. | Mar 10, 1992 | SESE |
| K903084 | MODULAR CATHCART FRACTURE SYSTEM | Depuy, Inc. | Oct 3, 1990 | SESE |
| K896580 | UNI-POLAR HEAD | Richards Medical Co., Inc. | Feb 15, 1990 | SESE |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Protek, Inc. | Jul 19, 1989 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 1 clearance
- Richards Medical Co., Inc. — 1 clearance
- Protek, Inc. — 1 clearance
- P.T. Latexindo Tobaperkasa — 1 clearance
- Medacta International — 1 clearance
