Fx Solutions: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Fx Solutions” (first 2011, latest 2017), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 218 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 239 |
| 2014 | 1 | 196 |
| 2015 | 2 | 251 |
| 2016 | 0 | — |
| 2017 | 2 | 139 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fx Solutions took a median 139 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 | 2 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Fx Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163669 | Humeris Shoulder | PHX | 2017-05-17 | 141 |
| K162455 | Humelock Reversed Shoulder | PHX | 2017-01-17 | 137 |
| K150488 | Humelock II Reversible Shoulder System | PHX | 2015-11-13 | 261 |
| K143721 | PRCT2 | HRS | 2015-08-27 | 241 |
| K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM | KWT | 2014-07-28 | 196 |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | HSD | 2013-11-09 | 234 |
| K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM | KWT | 2013-08-13 | 244 |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | HSD | 2011-11-09 | 203 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-06-04.
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 Solutions?
FDA lists 8 510(k) clearances under the applicant name “Fx Solutions” (first 2011, latest 2017), across 4 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 Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fx Solutions is 218 days.
Which FDA product codes appear under Fx Solutions?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 3); HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, 2); KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, 2).
Next steps
- See all 8 Fx Solutions clearances with predicates and recalls
- Run predicate analysis for product code PHX, Fx Solutions'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.