Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osseus Fusion Systems, LLC · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
109 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213590 | Blue Topaz Sacroiliac Screw System | Osseus Fusion Systems, LLC | 2022-03-01 | 109 | 0 |
| K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018-08-15 | 86 | 0 |
| K170844 | Gemini-C Hybrid Cervical Interbody System | Osseus Fusion Systems, LLC | 2017-07-03 | 104 | 0 |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | Osseus Fusion Systems, LLC | 2016-04-26 | 61 | 0 |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | Osseus Fusion Systems, LLC | 2013-08-08 | 50 | 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