Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osseus Fusion Systems — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
141 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023-02-10 | 93 | 0 |
| K222107 | Black Diamond™ POCT Spinal System | Osseus Fusion Systems | 2022-11-03 | 108 | 0 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022-05-06 | 141 | 0 |
| K192495 | Black Diamond Navigation Instruments | Osseus Fusion Systems | 2020-01-17 | 128 | 0 |
| K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019-10-29 | 84 | 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