Written and maintained by CASRAI Editorial Board
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Not medical advice. This page gives general product and regulatory information for laboratory, clinic and supply staff. It does not describe how to perform any procedure and does not recommend a product for any patient.
Short answer
Bone cement is an implantable material, usually made from polymethylmethacrylate (PMMA) or related methacrylate polymers, that FDA regulates as a Class II device under 21 CFR 888.3027. Cement mixers, cement dispensers (the syringe-like “gun”) and cement monomer vapor evacuators are separate devices with their own classifications: all three are Class I.
Definition and scope
Under 21 CFR 888.3027, 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 regulation states it is intended for arthroplastic procedures of the hip, knee and other joints, for the fixation of polymer or metallic prosthetic implants to living bone. The classification is Class II (special controls), and the named special control is FDA’s guidance document on PMMA bone cement.
The regulation therefore defines bone cement by its intended use (fixing a prosthetic implant to bone) and by its material family. Equipment used around the cement is classified separately, which is why searches for a “bone cement mixer” or “bone cement gun” lead to different regulations than the cement itself.
How the related devices are classified
FDA’s device classification database (openFDA) lists three product codes for the equipment that supports bone cement use, each under the orthopedic specialty. The corresponding regulations in 21 CFR Part 888 describe each device in a single sentence.
Bone cement mixer
Product code JDZ, “Mixer, Cement, For Clinical Use”, is Class I under 21 CFR 888.4210, “Cement mixer for clinical use.” The regulation identifies it as a device consisting of a container intended for use in mixing bone cement.
Bone cement gun (cement dispenser)
Product code KIH, “Dispenser, Cement”, is Class I under 21 CFR 888.4200, “Cement dispenser.” The regulation identifies it as a nonpowered syringe-like device intended for use in placing bone cement.
Cement monomer vapor evacuator
Product code JDY, “Evacuator, Vapor, Cement Monomer”, is Class I under 21 CFR 888.4220, “Cement monomer vapor evacuator.” The regulation identifies it as a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement.
Types of bone cement
Two groupings apply. By material, 21 CFR 888.3027 names methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, and copolymers containing PMMA and polystyrene. By formulation, the laboratory literature distinguishes plain cement from antibiotic-loaded cement. Neut and colleagues studied six commercial gentamicin-loaded PMMA cements and also measured release after gentamicin was added by hand to plain commercial cements in three of the brands (Acta Orthopaedica 2003;74(6):670-676). Release from the hand-added versions was lower than from the manufacturer-loaded cements.
Regulatory cross-walk: cement versus the equipment around it
| Item | FDA product code | 21 CFR section | Class | What the regulation says |
|---|---|---|---|---|
| PMMA bone cement | Separate code under 888.3027 | 888.3027 | Class II (special controls) | Implanted device for fixing prosthetic implants to living bone in arthroplasty |
| Cement mixer for clinical use | JDZ | 888.4210 | Class I (general controls); 510(k) exempt subject to 888.9 | A container intended for mixing bone cement |
| Cement dispenser | KIH | 888.4200 | Class I (general controls); 510(k) exempt subject to 888.9 | A nonpowered syringe-like device for placing bone cement |
| Cement monomer vapor evacuator | JDY | 888.4220 | Class I (general controls); 510(k) exempt subject to 888.9 | Contains or removes fumes such as monomer vapor from bone cement during surgery |
Class I here means general controls only, and the three equipment regulations exempt the device from premarket notification (510(k)) subject to the limitations in 21 CFR 888.9. Class II cement is subject to special controls in addition to general controls. A supply or procurement reader can use this table to see that a request for “bone cement” and a request for a mixer or dispenser fall under different regulatory entries. For background on how FDA reaches a classification when no existing device fits, see FDA De Novo classification.
Where it matters for labs, clinics and supply decisions
Mixing method and antibiotic release
In the same Neut study, comparing vacuum mixing (Cemvac) with hand mixing across the six brands, vacuum mixing reduced cement porosity in all six. Total gentamicin release fell significantly in three of the six brands and rose significantly in one; the authors concluded that vacuum mixing causes only a minor reduction in release compared with hand mixing. The finding shows that preparation method is a variable studied in the laboratory literature, and not a fixed property of a cement. It is a laboratory result and not guidance for any clinical decision.
Related orthopedic and surgical topics
Staff who handle orthopedic instruments and implants may also want the CASRAI guides on the osteotome, orthopedic sutures and the TORP middle-ear prosthesis.
Common misunderstandings
- “Bone cement” does not mean the mixer or gun. The cement is the implanted material (Class II). The mixer, dispenser and vapor evacuator are separate Class I devices with their own product codes.
- Bone cement is not defined as a general bone-filling material. 21 CFR 888.3027 defines it by fixation of prosthetic implants to living bone in arthroplasty, and the regulation text does not use the term “bone void filler”.
- Class I does not mean unregulated. Class I devices are subject to general controls; the exemption from 510(k) is subject to the limitations in 21 CFR 888.9.
FAQ
What is bone cement?
An implanted device made from methylmethacrylate, PMMA, esters of methacrylic acid or PMMA-polystyrene copolymers, intended to fix prosthetic implants to living bone in joint arthroplasty (21 CFR 888.3027).
What are the types of bone cement?
The regulation names several material families (methylmethacrylate, PMMA, methacrylate esters and PMMA-polystyrene copolymers). Published studies, such as Neut et al. 2003, also distinguish plain cement from antibiotic-loaded cement.
What is a bone cement mixer?
A device consisting of a container intended for mixing bone cement. FDA lists it as product code JDZ, Class I, under 21 CFR 888.4210.
What is a bone cement gun?
FDA’s term is “cement dispenser”: a nonpowered syringe-like device intended for placing bone cement, product code KIH, Class I, under 21 CFR 888.4200.
What is a cement monomer vapor evacuator?
A device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement. FDA lists it as product code JDY, Class I, under 21 CFR 888.4220.
Is bone void filler the same as bone cement?
Not by regulatory definition. 21 CFR 888.3027 defines bone cement by its materials and by its use in fixing prosthetic implants to living bone in arthroplasty, and it does not use the term “bone void filler”.
Is bone cement a Class II device?
Yes. 21 CFR 888.3027 classifies PMMA bone cement as Class II (special controls).
Sources
- 21 CFR 888.3027, Polymethylmethacrylate (PMMA) bone cement. https://www.law.cornell.edu/cfr/text/21/888.3027 (checked 2026-10-30).
- 21 CFR 888.4210, Cement mixer for clinical use. https://www.law.cornell.edu/cfr/text/21/888.4210 (checked 2026-10-30).
- 21 CFR 888.4200, Cement dispenser. https://www.law.cornell.edu/cfr/text/21/888.4200 (checked 2026-10-30).
- 21 CFR 888.4220, Cement monomer vapor evacuator. https://www.law.cornell.edu/cfr/text/21/888.4220 (checked 2026-10-30).
- FDA device classification database via openFDA, product codes JDZ, KIH, JDY. https://api.fda.gov/device/classification.json (checked 2026-10-30).
- Neut D, et al. The effect of mixing on gentamicin release from polymethylmethacrylate bone cements. Acta Orthopaedica 2003;74(6):670-676. doi:10.1080/00016470310018180. https://actaorthop.org/actao/article/view/19823; abstract also at https://pubmed.ncbi.nlm.nih.gov/ (checked 2026-10-30).
