Fx Shoulder Solutions SAS
Viriat Auvergne-Rhone-Alpes, FR
Fx Shoulder Solutions SAS appears in FDA device records in Viriat Auvergne-Rhone-Alpes, FR. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Fx Shoulder Solutions SAS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Fx Solutions510(k), enforcement report, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for Fx Shoulder Solutions SAS between 2011 and 2017. The busiest year on record is 2013, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163669 | Humeris Shoulder | PHX | Substantially Equivalent | |
| K162455 | Humelock Reversed Shoulder | PHX | Substantially Equivalent | |
| K150488 | Humelock II Reversible Shoulder System | PHX | Substantially Equivalent | |
| K143721 | PRCT2 | HRS | Substantially Equivalent | |
| K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM | KWT | Substantially Equivalent | |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | HSD | Substantially Equivalent | |
| K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM | KWT | Substantially Equivalent | |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | HSD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009532798 | 3009532798 | Fx Shoulder Solutions SAS | 1663 rue de Majornas, Viriat Auvergne-Rhone-Alpes 01440 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LXHOrthopedic Manual Surgical Instrument
- HRSPlate, Fixation, Bone
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- PHXShoulder Prosthesis, Reverse Configuration
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2469-2018 | Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | Class II | Terminated | |
| Z-2468-2018 | Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain