Data / Medical devices / Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (MBP): 34 FDA-registered makers in 2 countries
34 establishments in 2 countries are registered with the FDA to make Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (product code MBP, Class 2, 21 CFR 888.3045). 13 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on November 21, 2024, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MBP
- Device class
- 2
- Regulation
- 888.3045
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 33 |
| South Korea | 1 |
Makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Osteotech, Inc. | Eatontown, NJ, United States | Manufacturer | 4 | March 6, 2013 | 0 | 2 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 3 | June 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Isotis Orthobiologics, Inc | Irvine, CA, United States | Complaint file establishment, Manufacturer | 3 | March 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 3 | March 6, 2013 | 0 | 4 | 0 | api.fda.gov |
| Lifenet Health | Virginia Beach, VA, United States | Manufacturer | 2 | November 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| LifeNet Health | Virginia Bch, VA, United States | Manufacturer | 2 | November 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| LifeNet Health | Plainfield, IN, United States | Manufacturer | 2 | November 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hans Biomed Corp. | Daejeon, South Korea | Manufacturer | 1 | November 15, 2012 | 0 | 0 | 0 | api.fda.gov |
| LifeNet Health Northwest | Renton, WA, United States | Manufacturer | 1 | November 28, 2005 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Manufacturer | 1 | September 6, 2006 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 1 | January 26, 2006 | 0 | 1 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 1 | January 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Manufacturer, Repackager or relabeler | 1 | May 31, 2013 | 0 | 3 | 0 | api.fda.gov |
| Allosource | Centennial, CO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amend Surgical, Inc. | Alachua, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bone Solutions, Inc. | Colleyville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Berkeley Advanced Biomaterials | Berkeley, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Testing - CT, LLC | Willington, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Olyphant, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Edison, NJ, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Jessup, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secada Medical, LLC D.B.A Ventris Medical | Newport Beach, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics Radiation Technologies, LLC | San Diego, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.