| ASTM F451-16 Standard Specification for Acrylic Bone Cement |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 8-450 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Materials |
| FDA Tech | John Goode FDA/OMPT/CDRH/ODE/DOD/JFDB2/ 301-796-6407 john.goode@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the predough or dough stage in accordance with the manufacturer's recommendations.
1.2 Units of premeasured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place.
1.3 While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient.
1.4 This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature (1, 2).2
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3027 | Bone Cement | Class 2 | LOD |
| §888.3027 | Bone Cement, Antibiotic | Class 2 | MBB |
| §888.3027 | Cement, Bone, Vertebroplasty | Class 2 | NDN |
| There is no relevant guidance developed at this time. |