MBP
31 FDA 510(k) clearances · Product code
181 daysmedian time to decision
332 days90th percentile
31clearances measured
FDA profile
- Official device name
- Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2010: 14 · 2011: 18 · 2012: 24 · 2013: 16 · 2014: 15 · 2015: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PliaFX Flo (K242799) | Lifenet Health | 2024-11-21 |
| Vivorte Trabexus EB (K143547) | Vivorte, Inc. | 2015-01-14 |
| VIVORTE BVF (K130703) | Vivorte, Inc. | 2013-09-12 |
| OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (K130498) | Bacterin International, Inc. | 2013-05-31 |
| CLEARED UNDER GRAFTON II EDBM (K122513) | Medtronic Sofamor Danek, Inc. | 2013-03-06 |
| SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (K113728) | Hans Biomed Corp. | 2012-11-15 |
| ACCELL EVO3 (FORMERLY ACCELL A2I) (K103742) | Integra Life Sciences | 2011-03-17 |
| ACCELL EVO3C (K091193) | Isotis Orthobiologics, Inc. | 2009-08-10 |
| DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (K080399) | Musculoskeletal Transplant Foundation | 2008-10-10 |
| ACCELL TBM-R (K081817) | Isotis Orthobiologics, Inc. | 2008-09-24 |
| SYGNAL DBM (K080405) | Musculoskeletal Transplant Foundation | 2008-08-28 |
| CAP PLUS, EQUIVABONE, CAP/DBM (K080329) | Etex Corp. | 2008-04-28 |
| SYGNAL DBM (K073329) | Musculoskeletal Transplant Foundation | 2008-02-28 |
| OPTECURE; OPTECURE + CCC (K063685) | Exactech, Inc. | 2007-06-07 |
| DBX DEMINERALIZED BONE MATRIX MIX (K063676) | Musculoskeletal Transplant Foundation | 2007-03-05 |
| DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY (K061131) | Orthocon, Inc. | 2007-02-08 |
| PLEXUR P (K061982) | Osteotech, Inc. | 2007-02-07 |
| DBX STRIP (K062205) | Musculoskeletal Transplant Foundation | 2007-02-05 |
| PROGENIX DBM PUTTY AND PASTE (K060794) | Medtronic Sofamor Danek | 2006-12-18 |
| OPTECURE +CCC (K061668) | Exactech, Inc. | 2006-09-12 |
| BIOSET XC (K060180) | Regeneration Technologies, Inc. | 2006-09-06 |
| AFT ALLOGRAFT FILLER TUBE (K060161) | Musculoskeletal Transplant Foundation | 2006-03-21 |
| OPTECURE (K050806) | Exactech, Inc. | 2006-02-08 |
| OSTEOSET DBM PELLETS (K053642) | Wrightmedicaltechnologyinc | 2006-01-26 |
| DBX STRIP (K042829) | Musculoskeletal Transplant Foundation | 2006-01-13 |
| ALLOCRAFT DBM (K052735) | Lifecell Corp. | 2005-12-28 |
| GRAFTON DBM (K051195) | Osteotech, Inc. | 2005-12-16 |
| VIAGRAF DBM PASTE (K043209) | Osteotech, Inc. | 2005-12-05 |
| ORTHOBLAST II PUTTY AND PASTE (K050642) | Isotis Orthobiologics, Inc. | 2005-12-05 |
| OPTIUM DBM GEL AND PUTTY (K053098) | Lifenet | 2005-11-28 |
| GRAFTON PLUS DBM PASTE (K043048) | Osteotech, Inc. | 2005-11-23 |
Track MBP automatically
Every clearance here is in the API, with alerts when new ones post.