Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Expanding Innovations, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
161 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025-06-25 | 85 | 0 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Ex | Expanding Innovations, Inc. | 2025-06-16 | 20 | 0 |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 | 81 | 0 |
| K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | 2023-02-14 | 126 | 0 |
| K222797 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2022-10-14 | 28 | 0 |
| K220655 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2022-03-24 | 17 | 0 |
| K203802 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2021-06-07 | 161 | 0 |
| K201145 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2020-09-10 | 134 | 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