Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fx Shoulder USA, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
387 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2024-05-15 | 104 | 0 |
| K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2023-06-05 | 168 | 0 |
| K222936 | Humeris® 135 Shoulder System | Fx Shoulder USA, Inc. | 2022-11-07 | 42 | 0 |
| K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022-06-07 | 253 | 0 |
| K210790 | Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2021-08-25 | 162 | 0 |
| K201391 | Easytech® Anatomical Shoulder System | Fx Shoulder USA, Inc. | 2021-02-16 | 265 | 0 |
| K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | 2020-07-16 | 387 | 0 |
| K191146 | Humelock TiN Coated Glenosphere | Fx Shoulder USA, Inc. | 2020-07-15 | 442 | 1 |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | 2020-04-29 | 145 | 0 |
| K192799 | Glenoid Baseplate with Screw | Fx Shoulder USA, Inc. | 2020-02-21 | 144 | 0 |
| K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | 2019-10-08 | 55 | 1 |
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