Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MBP — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
181 daysmedian FDA review time
332 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242799 | PliaFX Flo | Lifenet Health | 2024-11-21 | 65 | 0 |
| K143547 | Vivorte Trabexus EB | Vivorte, Inc. | 2015-01-14 | 30 | 1 |
| K130703 | VIVORTE BVF | Vivorte, Inc. | 2013-09-12 | 181 | 1 |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | 2013-05-31 | 94 | 0 |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Medtronic Sofamor Danek, Inc. | 2013-03-06 | 201 | 0 |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | Hans Biomed Corp. | 2012-11-15 | 332 | 0 |
| K103742 | ACCELL EVO3 (FORMERLY ACCELL A2I) | Integra Life Sciences | 2011-03-17 | 84 | 0 |
| K091193 | ACCELL EVO3C | Isotis Orthobiologics, Inc. | 2009-08-10 | 109 | 1 |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE | Musculoskeletal Transplant Foundation | 2008-10-10 | 239 | 0 |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | 2008-09-24 | 90 | 0 |
| K080405 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-08-28 | 196 | 0 |
| K080329 | CAP PLUS, EQUIVABONE, CAP/DBM | Etex Corp. | 2008-04-28 | 81 | 0 |
| K073329 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-02-28 | 93 | 0 |
| K063685 | OPTECURE; OPTECURE + CCC | Exactech, Inc. | 2007-06-07 | 177 | 0 |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | Musculoskeletal Transplant Foundation | 2007-03-05 | 84 | 0 |
| K061131 | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | Orthocon, Inc. | 2007-02-08 | 290 | 0 |
| K061982 | PLEXUR P | Osteotech, Inc. | 2007-02-07 | 209 | 0 |
| K062205 | DBX STRIP | Musculoskeletal Transplant Foundation | 2007-02-05 | 188 | 0 |
| K060794 | PROGENIX DBM PUTTY AND PASTE | Medtronic Sofamor Danek | 2006-12-18 | 270 | 0 |
| K061668 | OPTECURE +CCC | Exactech, Inc. | 2006-09-12 | 90 | 0 |
| K060180 | BIOSET XC | Regeneration Technologies, Inc. | 2006-09-06 | 226 | 0 |
| K060161 | AFT ALLOGRAFT FILLER TUBE | Musculoskeletal Transplant Foundation | 2006-03-21 | 60 | 1 |
| K050806 | OPTECURE | Exactech, Inc. | 2006-02-08 | 315 | 0 |
| K053642 | OSTEOSET DBM PELLETS | Wrightmedicaltechnologyinc | 2006-01-26 | 27 | 0 |
| K042829 | DBX STRIP | Musculoskeletal Transplant Foundation | 2006-01-13 | 458 | 0 |
| K052735 | ALLOCRAFT DBM | Lifecell Corp. | 2005-12-28 | 89 | 2 |
| K051195 | GRAFTON DBM | Osteotech, Inc. | 2005-12-16 | 220 | 29 |
| K043209 | VIAGRAF DBM PASTE | Osteotech, Inc. | 2005-12-05 | 381 | 0 |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Isotis Orthobiologics, Inc. | 2005-12-05 | 269 | 0 |
| K053098 | OPTIUM DBM GEL AND PUTTY | Lifenet | 2005-11-28 | 25 | 0 |
| K043048 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | 2005-11-23 | 384 | 14 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda