Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biostructures, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160446 | MCP Bone Putty | Biostructures, LLC | 2016-11-07 | 264 | 0 |
| K142276 | MCS Bone Graft | Biostructures, LLC | 2015-01-16 | 154 | 0 |
| K132071 | BIOACTIVE BONE GRAFT PUTTY | Biostructures, LLC | 2014-01-10 | 191 | 0 |
| K112857 | INTERFACE BONE VOID FILLER | Biostructures, LLC | 2011-12-13 | 74 | 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