Cleared Traditional

StageOne? Select Hip Cement Spacer Molds

K222760 · Biomet, Inc. · Orthopedic
Dec 2022
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K222760 is an FDA 510(k) clearance for the StageOne? Select Hip Cement Spacer Molds, a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 28, 2022, 106 days after receiving the submission on September 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K222760 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2022
Decision Date December 28, 2022
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBB — Bone Cement, Antibiotic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027