Atlas FDA

MBB

19 FDA 510(k) clearances · Product code

107 daysmedian time to decision
275 days90th percentile
19clearances measured

FDA profile

Official device name
Bone Cement, Antibiotic
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 649 · 2022: 275 · 2023: 262 · 2024: 213 · 2025: 175 · 2026: 109
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SpaceFix Shoulder Spacer (K252443)G21, S.R.L.2025-09-15
GENTAFIX® (1, 3, 3MV) (K242216)Teknimed Sas2024-12-18
Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (K240856)Osartis GmbH2024-11-20
StageOne™ Select Hip Cement Spacer Molds (K222760)Biomet, Inc.2022-12-28
StageOne™ Shoulder Cement Spacer Molds (K221968)Biomet, Inc.2022-09-15
StageOne Knee Cement Spacer Molds (K213287)Biomet, Inc.2022-09-02
SpaceFlex Shoulder (K202338)G21, S.R.L.2021-02-17
SpaceFlex Knee - 80mm Size (K201960)G21, S.R.L.2020-08-13
G21 SpaceFlex Hip (K192041)G21, S.R.L.2019-10-29
SpaceFlex Knee (K190216)G21, S.R.L.2019-06-09
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273)Biomet, Inc.2017-01-25
StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166)Biomet, Inc.2016-09-08
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (K160071)Biomet, Inc.2016-06-16
Refobacin Bone Cement R (K150850)Biomet, Inc.2015-07-16
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS (K131135)Biomet Manufacturing Corp2014-01-22
SMARTSET GMV GENTAMICIN BONE CEMENT (K081163)DePuy Orthopaedics, Inc.2008-05-14
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT (K063857)Howmedica Osteonics Corp.2007-02-26
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT (K061144)DePuy Orthopaedics, Inc.2006-06-08
DEPUY CMW 1 GENTAMICIN BONE CEMENT (K053002)DePuy Orthopaedics, Inc.2005-11-22

Track MBB automatically

Every clearance here is in the API, with alerts when new ones post.