Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Small Bone Innovations, 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) |
|---|---|---|---|---|---|
| K052576 | SBI AUTOFIX | Small Bone Innovations, LLC | 2005-11-07 | 49 | 1 |
| K051747 | SBI WRISTFIT | Small Bone Innovations, LLC | 2005-09-06 | 69 | 0 |
| K051605 | SBI K-WIRES | Small Bone Innovations, LLC | 2005-08-10 | 55 | 0 |
| K050462 | SBI HAND FIXATION SYSTEM (TM) | Small Bone Innovations, LLC | 2005-04-26 | 62 | 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