PBI · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Orthopedic · 21 CFR 888.3310 · Class 2
Overview
| Product Code | PBI |
|---|---|
| Device Name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive |
| Regulation | 21 CFR 888.3310 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212512 | G7® Vivacit-E® Freedom® Constrained Liner | Zimmer, Inc. | Apr 28, 2022 | SESE |
| K121874 | G7 ACETABULAR SYSTEM | Biomet Manufacturing Corp | Nov 23, 2012 | SESE |
Top Applicants
- Zimmer, Inc. — 1 clearance
- Biomet Manufacturing Corp — 1 clearance
