510(k) K161273

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis by Biomet, Inc. — Product Code MBB

K161273 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis". The FDA issued a decision of Substantially Equivalent on January 25, 2017. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Biomet, Inc. has at least 10 other 510(k) clearances on record.