Fx Shoulder USA, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Fx Shoulder USA, Inc.” (first 2019, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 162 days. Since 2017 the median was 162 days, against 141 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 |
|---|---|---|
| 2019 | 1 | 55 |
| 2020 | 4 | 266 |
| 2021 | 2 | 214 |
| 2022 | 2 | 148 |
| 2023 | 1 | 168 |
| 2024 | 1 | 104 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fx Shoulder USA, Inc. took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 9 | 9 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 1 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Fx Shoulder USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240278 | Full Wedge Lateralized and Augmented Baseplates | PHX | 2024-05-15 | 104 |
| K223801 | FX V135(TM) Shoulder Prosthesis | PHX | 2023-06-05 | 168 |
| K222936 | Humeris® 135 Shoulder System | PHX | 2022-11-07 | 42 |
| K213117 | FX V135 Shoulder Prosthesis | PHX | 2022-06-07 | 253 |
| K210790 | Lateralized and Augmented Baseplates | PHX | 2021-08-25 | 162 |
| K201391 | Easytech® Anatomical Shoulder System | PKC | 2021-02-16 | 265 |
| K191698 | TiN Coated Humeral Head | KWT | 2020-07-16 | 387 |
| K191146 | Humelock TiN Coated Glenosphere | PHX | 2020-07-15 | 442 |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | PHX | 2020-04-29 | 145 |
| K192799 | Glenoid Baseplate with Screw | PHX | 2020-02-21 | 144 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fx Shoulder USA, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fx Shoulder USA, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Fx Shoulder USA, Inc.” (first 2019, latest 2024), 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 Fx Shoulder USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fx Shoulder USA, Inc. is 162 days. Since 2017: 162 days, versus 141 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fx Shoulder USA, Inc.?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 9); KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, 1); PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, 1).
Next steps
- See all 11 Fx Shoulder USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PHX, Fx Shoulder USA, 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.