Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isotis Orthobiologics, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
401 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091193 | ACCELL EVO3C | Isotis Orthobiologics, Inc. | 2009-08-10 | 109 | 1 |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | 2008-09-24 | 90 | 0 |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis Orthobiologics, Inc. | 2007-10-15 | 210 | 0 |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Isotis Orthobiologics, Inc. | 2005-12-05 | 269 | 0 |
| K052098 | CONNEXUS, .5CC, MODEL 023000-005 | Isotis Orthobiologics, Inc. | 2005-09-07 | 35 | 0 |
| K043573 | DYNAGRAFT II DENTAL | Isotis Orthobiologics, Inc. | 2005-07-29 | 214 | 0 |
| K050690 | CONNEXUS | Isotis Orthobiologics, Inc. | 2005-07-07 | 112 | 0 |
| K040419 | DYNAGRAFT II | Isotis Orthobiologics, Inc. | 2005-03-25 | 401 | 0 |
| K042706 | OSSATURA DENTAL | Isotis Orthobiologics, Inc. | 2004-10-20 | 20 | 0 |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | Isotis Orthobiologics, Inc. | 2004-09-16 | 55 | 0 |
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