# Medical Devices; Reclassification of Polymethylmethacrylate (PMMA) Bone Cement
> **Food and Drug Administration** · Final rule. · Published 2002-07-17 · Effective 1999-10-14 · 67 FR 46852
## Document
- **Document number:** 02-18036
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 46852
- **CFR reference:** 21 CFR 888
- **Publication date:** 2002-07-17
- **Effective date:** 1999-10-14
- **HHS docket:** Docket No. 02P-0294
## Abstract

The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement 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 from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control for the device is a guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." The agency is reclassifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/07/17/02-18036/medical-devices-reclassification-of-polymethylmethacrylate-pmma-bone-cement)
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