FDA product code MBB: Bone Cement, Antibiotic
MBB is the FDA product code for bone cement, antibiotic. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. FDA has cleared 19 510(k) submissions under MBB, 6 in the last five years, from 7 different applicants. The average 510(k) review took 129 days (median 107); 116 days on average over the last three years. FDA has posted 7 recalls for MBB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bone Cement, Antibiotic |
| Device class | Class II |
| Regulation | 21 CFR 888.3027 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MBB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2019 | 2 | 108 |
| 2020 | 1 | 30 |
| 2021 | 1 | 184 |
| 2022 | 3 | 171 |
| 2024 | 2 | 190 |
| 2025 | 1 | 42 |
Compare with all 510(k) review times · Search every MBB clearance
Top MBB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 7 | 2022-12-28 |
| G21, S.R.L. | 5 | 2025-09-15 |
| DePuy Orthopaedics, Inc. | 3 | 2008-05-14 |
| Teknimed Sas | 1 | 2024-12-18 |
| Osartis GmbH | 1 | 2024-11-20 |
2 more applicants have MBB clearances. See the full list in Caduvo.
Most recent MBB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252443 | G21, S.R.L. | SpaceFix Shoulder Spacer | 2025-09-15 | 42 |
| K242216 | Teknimed Sas | GENTAFIX® (1, 3, 3MV) | 2024-12-18 | 142 |
| K240856 | Osartis GmbH | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | 2024-11-20 | 237 |
| K222760 | Biomet, Inc. | StageOne Select Hip Cement Spacer Molds | 2022-12-28 | 106 |
| K221968 | Biomet, Inc. | StageOne Shoulder Cement Spacer Molds | 2022-09-15 | 72 |
Recalls for MBB devices
7 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code MBB?
MBB is the FDA product code for bone cement, antibiotic. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is MBB?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBB?
Across 19 cleared submissions the average was 129 days from receipt to decision (median 107).
Which companies have the most MBB clearances?
Biomet, Inc. (7); G21, S.R.L. (5); DePuy Orthopaedics, Inc. (3); Teknimed Sas (1); Osartis GmbH (1).
Have MBB devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MBB
- Run a recall and safety report across every MBB manufacturer
- Watch product code MBB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times