← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K254107

# Refobacin Bone Cement R (110034355) (K254107)

_Biomet France · LOD · Apr 15, 2026 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K254107

## Device Facts

- **Applicant:** Biomet France
- **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md)
- **Decision Date:** Apr 15, 2026
- **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.”

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K254107](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K254107)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com