Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthovita, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
274 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017-05-02 | 131 | 0 |
| K161447 | HydroSet XT | Orthovita, Inc. | 2016-10-06 | 134 | 0 |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | Orthovita, Inc. | 2016-02-12 | 57 | 0 |
| K153306 | Imbibe Needle | Orthovita, Inc. | 2015-12-18 | 32 | 0 |
| K140868 | STRYKER KWIC NEEDLE | Orthovita, Inc. | 2014-06-05 | 63 | 0 |
| K140414 | IMBIBE NEEDLE | Orthovita, Inc. | 2014-04-01 | 42 | 1 |
| K103173 | VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE | Orthovita, Inc. | 2011-02-07 | 102 | 0 |
| K101171 | ORTHOVITA PEEK SPACER | Orthovita, Inc. | 2011-01-25 | 274 | 0 |
| K102545 | FM-02 BONE GRAFT SUBSTITUTE | Orthovita, Inc. | 2010-10-27 | 54 | 0 |
| K091618 | VITOMATRIX | Orthovita, Inc. | 2010-09-27 | 481 | 0 |
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL | Orthovita, Inc. | 2009-06-05 | 507 | 1 |
| K083033 | VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED C | Orthovita, Inc. | 2008-11-06 | 27 | 0 |
| K081439 | VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE | Orthovita, Inc. | 2008-06-17 | 26 | 0 |
| K072184 | VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE | Orthovita, Inc. | 2007-09-18 | 43 | 0 |
| K052173 | VITAGEL SURGICAL HEMOSTAT SPRAY SET | Orthovita, Inc. | 2005-10-19 | 70 | 0 |
| K050795 | IMBIBE BONE MARROW ASPIRATION NEEDLE | Orthovita, Inc. | 2005-06-03 | 66 | 0 |
| K032288 | VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL | Orthovita, Inc. | 2003-12-19 | 148 | 0 |
| K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT | Orthovita, Inc. | 2003-12-08 | 90 | 1 |
| K032130 | VITOSS-FILLED CARTRIDGE | Orthovita, Inc. | 2003-11-05 | 117 | 0 |
| K032409 | VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER | Orthovita, Inc. | 2003-08-29 | 25 | 0 |
| K030208 | IMBIBE II SYRINGE | Orthovita, Inc. | 2003-04-16 | 85 | 0 |
| K023074 | IMBIBE BONE MARROW ASPIRATION SYRINGE | Orthovita, Inc. | 2003-03-11 | 176 | 0 |
| K011087 | ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SY | Orthovita, Inc. | 2001-09-19 | 162 | 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