Catalyst Orthoscience, Inc.
Catalyst Orthoscience, Inc. has 0 FDA recalls, 1 inspection, 13 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 10, 2024 · NAI
- Latest 510(k)
- Nov 6, 2025
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 13 | Oct 4, 2026 | Not stated | Current |
| Inspections | 1 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 10, 2024 | Naples, FL | Devices | No Action Indicated (NAI) | 3012552981 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252418 | Catalyst F1x Shoulder System | Nov 6, 2025 |
| K234105 | Catalyst F1x Shoulder System | Apr 5, 2024 |
| K232583 | Catalyst R1 Reverse Shoulder System | Sep 20, 2023 |
| K223655 | Catalyst R1 Reverse Shoulder System | May 9, 2023 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Nov 10, 2022 |
| K213349 | Catalyst R1 Reverse Shoulder System | Jun 23, 2022 |
| K211991 | Catalyst R1 Reverse Shoulder System | Jul 28, 2021 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Feb 12, 2021 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Sep 11, 2019 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | Jan 11, 2019 |
| K181287 | Catalyst CSR Shoulder System | Jul 12, 2018 |
| K173812 | Catalyst CSR 3 Peg Glenoids | Mar 9, 2018 |
| K152825 | Catalyst CSR Shoulder System | May 11, 2016 |