FDA product code MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
MBP is the FDA product code for filler, bone void, osteoinduction (w/o human growth factor). It is a Class II device, regulated under 21 CFR 888.3045 and reviewed by the Orthopedic panel. FDA has cleared 31 510(k) submissions under MBP, 1 in the last five years, from 17 different applicants. The average 510(k) review took 179 days (median 181); 65 days on average over the last three years. FDA has posted 41 recalls for MBP devices, 19 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
| Device class | Class II |
| Regulation | 21 CFR 888.3045 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MBP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 65 |
Compare with all 510(k) review times · Search every MBP clearance
Top MBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Musculoskeletal Transplant Foundation | 7 | 2008-10-10 |
| Osteotech, Inc. | 4 | 2007-02-07 |
| Isotis Orthobiologics, Inc. | 3 | 2009-08-10 |
| Exactech, Inc. | 3 | 2007-06-07 |
| Vivorte, Inc. | 2 | 2015-01-14 |
12 more applicants have MBP clearances. See the full list in Caduvo.
Most recent MBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242799 | Lifenet Health | PliaFX Flo | 2024-11-21 | 65 |
| K143547 | Vivorte, Inc. | Vivorte Trabexus EB | 2015-01-14 | 30 |
| K130703 | Vivorte, Inc. | VIVORTE BVF | 2013-09-12 | 181 |
| K130498 | Bacterin International, Inc. | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | 2013-05-31 | 94 |
| K122513 | Medtronic Sofamor Danek, Inc. | CLEARED UNDER GRAFTON II EDBM | 2013-03-06 | 201 |
Recalls for MBP devices
41 product recalls in 12 recall events; 19 initiated in the last five years and 19 still open. Most recent: 2023-09-26.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 19 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7175 — Injection, factor x, (human), 1 i.u.
- J7190 — Factor viii (antihemophilic factor, human) per i.u.
- J7180 — Injection, factor xiii (antihemophilic factor, human), 1 i.u.
Frequently asked questions
What is FDA product code MBP?
MBP is the FDA product code for filler, bone void, osteoinduction (w/o human growth factor). It is a Class II device, regulated under 21 CFR 888.3045 and reviewed by the Orthopedic panel.
What device class is MBP?
Class II, regulation 21 CFR 888.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBP?
Across 31 cleared submissions the average was 179 days from receipt to decision (median 181).
Which companies have the most MBP clearances?
Musculoskeletal Transplant Foundation (7); Osteotech, Inc. (4); Isotis Orthobiologics, Inc. (3); Exactech, Inc. (3); Vivorte, Inc. (2).
Have MBP devices been recalled?
Yes: 41 product recalls across 12 recall events; the most recent began 2023-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MBP
- Run a recall and safety report across every MBP manufacturer
- Watch product code MBP 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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