21 CFR 888.3027 — Bone Cement
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3027
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LOD | Bone Cement | 2 | 79 | Implant |
| MBB | Bone Cement, Antibiotic | 2 | 19 | Implant |
| NDN | Cement, Bone, Vertebroplasty | 2 | 108 | Implant |
| NUD | Vertebroplasty Compound, Calcium Based | 2 | 0 | Implant |
| OBL | Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty | 2 | 1 | Implant |
| OBM | Cement, Bone, Vertebroplasty, Pre-Formed, Modular | 2 | 0 | Implant |
| PML | Bone Cement, Posterior Screw Augmentation | 2 | 18 | Implant |
Special Controls
LOD — Bone Cement
*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.”
eCFR
MBB — Bone Cement, Antibiotic
*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.”
eCFR
NDN — Cement, Bone, Vertebroplasty
*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.”
eCFR
NUD — Vertebroplasty Compound, Calcium Based
*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.”
eCFR
OBL — Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
*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.”
eCFR
OBM — Cement, Bone, Vertebroplasty, Pre-Formed, Modular
*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.”
eCFR
PML — Bone Cement, Posterior Screw Augmentation
*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.”
eCFR
