Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shoulder Innovations, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
309 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026-04-13 | 112 | 0 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 | 157 | 0 |
| K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025-09-26 | 72 | 0 |
| K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025-02-11 | 232 | 0 |
| K213615 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2022-03-11 | 116 | 0 |
| K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2021-08-20 | 177 | 0 |
| K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019-11-29 | 91 | 0 |
| K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | 2018-10-23 | 309 | 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