← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K010586

# PALAMED BONE CEMENT (K010586)

_Merck Biomaterial GmbH · LOD · Oct 30, 2001 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K010586

## Device Facts

- **Applicant:** Merck Biomaterial GmbH
- **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md)
- **Decision Date:** Oct 30, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3027
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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.

## 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.”

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K010586](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K010586)

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