Catalyst Orthoscience, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Catalyst Orthoscience, Inc.” (first 2016, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 98 days, against 136 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 225 |
| 2017 | 0 | — |
| 2018 | 2 | 70 |
| 2019 | 2 | 94 |
| 2020 | 0 | — |
| 2021 | 2 | 93 |
| 2022 | 2 | 179 |
| 2023 | 2 | 90 |
| 2024 | 1 | 101 |
| 2025 | 1 | 97 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Catalyst Orthoscience, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 6 | 6 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 5 | 5 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 2 |
Review panels
- Orthopedic (13)
Most recent Catalyst Orthoscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252418 | Catalyst F1x Shoulder System | KWS | 2025-11-06 | 97 |
| K234105 | Catalyst F1x Shoulder System | PHX | 2024-04-05 | 101 |
| K232583 | Catalyst R1 Reverse Shoulder System | PHX | 2023-09-20 | 26 |
| K223655 | Catalyst R1 Reverse Shoulder System | PHX | 2023-05-09 | 154 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | KWS | 2022-11-10 | 100 |
| K213349 | Catalyst R1 Reverse Shoulder System | PHX | 2022-06-23 | 258 |
| K211991 | Catalyst R1 Reverse Shoulder System | PHX | 2021-07-28 | 30 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | PHX | 2021-02-12 | 156 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | KWT | 2019-09-11 | 68 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | KWT | 2019-01-11 | 121 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Catalyst Orthoscience, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Catalyst Orthoscience, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04968405: Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty (Completed, started 2022-07-22)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Catalyst Research Corp. (9 510(k)s)
- Catalyst, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Catalyst Orthoscience, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Catalyst Orthoscience, Inc.” (first 2016, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Catalyst Orthoscience, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catalyst Orthoscience, Inc. is 100 days. Since 2017: 98 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Catalyst Orthoscience, Inc.?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 6); KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, 5); KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 2).
Next steps
- See all 13 Catalyst Orthoscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PHX, Catalyst Orthoscience, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.