Cleared Traditional

StageOne Knee Cement Spacer Molds

K213287 · Biomet, Inc. · Orthopedic
Sep 2022
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K213287 is an FDA 510(k) clearance for the StageOne Knee 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 September 2, 2022, 336 days after receiving the submission on October 1, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K213287 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2021
Decision Date September 02, 2022
Days to Decision 336 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