Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Catalyst Orthoscience, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
156 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 | 97 | 0 |
| K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024-04-05 | 101 | 0 |
| K232583 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023-09-20 | 26 | 0 |
| K223655 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023-05-09 | 154 | 0 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 | 100 | 0 |
| K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022-06-23 | 258 | 0 |
| K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021-07-28 | 30 | 0 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021-02-12 | 156 | 0 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019-09-11 | 68 | 0 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019-01-11 | 121 | 0 |
| K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018-07-12 | 57 | 0 |
| K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | 2018-03-09 | 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