FDA product code MBV: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
MBV is the FDA product code for prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel. FDA has cleared 14 510(k) submissions under MBV, from 6 different applicants. The average 510(k) review took 86 days (median 58). FDA has posted 1 recall for MBV devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MBV clearance
Top MBV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Depuy, Inc. | 5 | 1983-09-01 |
| Richards Medical Co., Inc. | 2 | 1989-11-21 |
| Protek, Inc. | 2 | 1987-10-28 |
| Advanced Biosearch Assn. | 2 | 1983-08-16 |
| Richard'S Medical Equip., Inc. | 2 | 1983-03-29 |
1 more applicants have MBV clearances. See the full list in Caduvo.
Most recent MBV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010212 | Biomet, Inc. | OFFSET TIBIAL TRAY | 2001-02-14 | 22 |
| K884824 | Richards Medical Co., Inc. | TRICON-M TOTAL KNEE SYSTEM | 1989-11-21 | 368 |
| K873429 | Protek, Inc. | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | 1987-10-28 | 64 |
| K853730 | Protek, Inc. | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP | 1986-02-18 | 165 |
| K833200 | Richards Medical Co., Inc. | TRICON M TOTAL KNEE SYSTEM | 1983-11-29 | 71 |
Recalls for MBV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-15.
Frequently asked questions
What is FDA product code MBV?
MBV is the FDA product code for prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel.
What device class is MBV?
Class II, regulation 21 CFR 888.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBV?
Across 14 cleared submissions the average was 86 days from receipt to decision (median 58).
Which companies have the most MBV clearances?
Depuy, Inc. (5); Richards Medical Co., Inc. (2); Protek, Inc. (2); Advanced Biosearch Assn. (2); Richard'S Medical Equip., Inc. (2).
Have MBV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MBV
- Run a recall and safety report across every MBV manufacturer
- Watch product code MBV 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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