Data / Medical devices / United States / CATALYST ORTHOSCIENCE Inc
CATALYST ORTHOSCIENCE Inc: FDA-registered device maker in Naples, FL, United States, 13 510(k) clearances
CATALYST ORTHOSCIENCE Inc is registered with the FDA (registration 3012552981) in Naples, FL, United States. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012552981
- Address
- 14710 Tamiami Trail N., Suite #102, Naples, FL, United States, 34110
- Owner or operator
- Catalyst Orthoscience (10051942)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 23, 2016
- Registered through
- 2026
- Brand names listed
- Archer CSR Total Shoulder System, Archer R1 Reverse Shoulder System, CSR, Catalyst CSR 3 Peg Glenoids, Catalyst CSR Shoulder System, Catalyst EA Convertible Stemmed Shoulder, Catalyst F1x Shoulder System, Catalyst R1 Reverse Shoulder System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2025 | K252418 | Catalyst F1x Shoulder System | KWS | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| April 5, 2024 | K234105 | Catalyst F1x Shoulder System | PHX | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| September 20, 2023 | K232583 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| May 9, 2023 | K223655 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| November 10, 2022 | K222317 | Catalyst EA Convertible Stemmed Shoulder | KWS | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| June 23, 2022 | K213349 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| July 28, 2021 | K211991 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| February 12, 2021 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | PHX | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| September 11, 2019 | K191811 | Catalyst OrthoScience CSR Shoulder System | KWT | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182500 | Catalyst CSR Press-Fit Humeral Components | KWT | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| July 12, 2018 | K181287 | Catalyst CSR Shoulder System | KWT | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| March 9, 2018 | K173812 | Catalyst CSR 3 Peg Glenoids | KWT | Substantially Equivalent | Catalyst Orthoscience, Inc. | accessdata.fda.gov |
| May 11, 2016 | K152825 | Catalyst CSR Shoulder System | KWT | Substantially Equivalent | Catalyst Orthoscience, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Updated November 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.