FDA product code MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
MBH is the FDA product code for prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3565 and reviewed by the Orthopedic panel. FDA has cleared 146 510(k) submissions under MBH, 38 in the last five years, from 48 different applicants. The average 510(k) review took 121 days (median 90); 133 days on average over the last three years. FDA has posted 103 recalls for MBH devices, 20 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3565 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MBH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 122 |
| 2018 | 6 | 111 |
| 2019 | 1 | 122 |
| 2020 | 7 | 160 |
| 2021 | 6 | 79 |
| 2022 | 7 | 113 |
| 2023 | 6 | 130 |
| 2024 | 10 | 86 |
| 2025 | 8 | 126 |
| 2026 | 7 | 186 |
Compare with all 510(k) review times · Search every MBH clearance
Top MBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer, Inc. | 19 | 2026-05-28 |
| Smith & Nephew, Inc. | 12 | 2026-09-08 |
| Howmedica Osteonics Corp. | 9 | 2020-05-13 |
| Microport Orthopedics, Inc. | 8 | 2026-08-21 |
| Wrightmedicaltechnologyinc | 8 | 2013-03-21 |
43 more applicants have MBH clearances. See the full list in Caduvo.
Most recent MBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261275 | Corin, Ltd. | Unity Total Knee System, Unity Knee Cementless CR Femur | 2026-09-17 | 153 |
| K261462 | Smith & Nephew, Inc. | LANDMARK Total Knee System | 2026-09-08 | 127 |
| K253728 | Microport Orthopedics, Inc. | EVOLUTION® AM BIOFOAM® Tibial System | 2026-08-21 | 270 |
| K251840 | Zimmer, Inc. | Zimmer® Persona® Personalized Knee System | 2026-05-28 | 346 |
| K253189 | Zimmer, Inc. | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | 2026-03-09 | 164 |
Recalls for MBH devices
103 product recalls in 44 recall events; 20 initiated in the last five years and 22 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 10 |
| 2018 | 5 |
| 2019 | 5 |
| 2020 | 3 |
| 2021 | 1 |
| 2023 | 5 |
| 2024 | 11 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code MBH?
MBH is the FDA product code for prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3565 and reviewed by the Orthopedic panel.
What device class is MBH?
Class II, regulation 21 CFR 888.3565. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBH?
Across 146 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most MBH clearances?
Zimmer, Inc. (19); Smith & Nephew, Inc. (12); Howmedica Osteonics Corp. (9); Microport Orthopedics, Inc. (8); Wrightmedicaltechnologyinc (8).
Have MBH devices been recalled?
Yes: 103 product recalls across 44 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MBH
- Run a recall and safety report across every MBH manufacturer
- Watch product code MBH 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.
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