Freedom – ProFlor Inguinal Hernia Implant
Freedom ProFlor is a polypropylene implant for open inguinal hernia repair. Its looped core fills the hernia opening while an underlay mesh patch reinforces the defect and helps hold the…
Freedom ProFlor is a polypropylene implant for open inguinal hernia repair. Its looped core fills the hernia opening while an underlay mesh patch reinforces the defect and helps hold the implant in position.
Two meshes and two small polypropylene rings form the implant. A separate delivery device compresses it for placement into the prepared defect, where surrounding tissue grips the deployed structure.
Listed Item
The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.
Sizes and Fixation
The range includes a 25 mm core with a 60 mm underlay patch and a 40 mm core with a 70 mm patch. The implant is supplied sterile for single-patient use and is designed for placement without sutures.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Insightra Medical, Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K113552 |
| Record published | 2015-07-22 |
| Record revised | 2022-06-10 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper box implant of 6, pack of 6 |
| Sizes | Outer diameter 25 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FIHR 40mm | Outer Diameter 40 mm | In distribution |
| FIHR 25mmE | Outer Diameter 25 mm | In distribution |
| FIHR 25mm | Outer Diameter 25 mm | In distribution |
| FIHR 40mmE | Outer Diameter 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| Parietex | Sofradim Production | 82 |
| DynaMesh | FEG Textiltechnik Forschungs- und Entwicklungsges. mbH | 45 |
| Symbotex | Sofradim Production | 35 |
| Silicone Sheeting Reinforced | Bentec Medical OpCo, LLC. | 33 |
| Parietene | Sofradim Production | 32 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 31 |
| Prolite | Atrium Medical Corporation | 31 |
| Gore Seamguard Bioabsorbable Staple Line Reinforce | W. L. Gore & Associates, Inc. | 30 |
| Surgimesh®wn | Aspide Medical | 28 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142192 | 2015-05-07 |
| K140967 | 2014-06-10 |
| K113552 | 2012-08-23 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990028 | 2003-12-04 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.