Product code MBB— Orthopedic
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
- Classification name
- Bone Cement, Antibiotic
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code MBB
FDA has cleared devices under product code MBB between 2005 and 2025, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2022
- 2021
- 2020
- 2019
- 2017
- 2016
- 2015
- 2014
- 2008
- 2007
- 2006
- 2005
Top applicants under product code MBB
Adverse events under product code MBB
product code MBB- Death
- 27
- Injury
- 1,412
- Malfunction
- 551
- Total
- 1,990
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MBB
- K252443 — SpaceFix Shoulder Spacer
- K242216 — GENTAFIX® (1, 3, 3MV)
- K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
- K222760 — StageOne Select Hip Cement Spacer Molds
- K221968 — StageOne Shoulder Cement Spacer Molds
- K213287 — StageOne Knee Cement Spacer Molds
- K202338 — SpaceFlex Shoulder
- K201960 — SpaceFlex Knee - 80mm Size
- K192041 — G21 SpaceFlex Hip
- K190216 — SpaceFlex Knee
- K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- K161166 — StageOne Select Cement Spacer Molds for Temporary Hip Replacement
- K160071 — StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
- K150850 — Refobacin Bone Cement R
- K131135 — BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
- K081163 — SMARTSET GMV GENTAMICIN BONE CEMENT
- K063857 — SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
- K061144 — DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
- K053002 — DEPUY CMW 1 GENTAMICIN BONE CEMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.