← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K002652

# SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII (K002652)

_Stryker Corp. · LOD · Jan 26, 2001 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K002652

## Device Facts

- **Applicant:** Stryker Corp.
- **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md)
- **Decision Date:** Jan 26, 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/K002652](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K002652)

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