OBL · Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
Orthopedic · 21 CFR 888.3027 · Class 2
Overview
| Product Code | OBL |
|---|---|
| Device Name | Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063606 | MODIFICATION TO STAXX FX SYSTEM | Spine Wave, Inc. | Apr 13, 2007 | SESE |
Top Applicants
- Spine Wave, Inc. — 1 clearance
