X-Repair
X-Repair is a bioabsorbable mesh used to reinforce weakened soft tissue during surgery. Its applications include reinforcement of tendon repairs made with sutures or suture anchors,…
X-Repair is a bioabsorbable mesh used to reinforce weakened soft tissue during surgery. Its applications include reinforcement of tendon repairs made with sutures or suture anchors, including rotator cuff, patellar, Achilles, biceps and quadriceps repairs.
The rectangular mesh is flexible and double layered, with a woven structure made from poly-L-lactic acid fibers. Locked upper and lower edges and welded ends form the finished scaffold.
Listed Item
X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 30mm (WxL)
Role in Repair
The mesh supplements the repair and does not replace normal tissue or supply its full mechanical strength. Sutures and anchors provide the mechanical fixation for the tendon repair. X-Repair is supplied sterile for single use.
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 | Synthasome, United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| 510(k) | K141394 |
| Record published | 2016-01-05 |
| Record revised | 2025-08-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 30 to 43 mm; width 25 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z009-30 | Length 30 mm | In distribution |
| Z009 | Width 25 mm | In distribution |
| Z009-35 | Length 35 mm | In distribution |
| Z010-30 | Width 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 |
|---|---|
| K141394 | 2014-08-06 |
| K141499 | 2014-07-02 |
| K083307 | 2009-03-27 |
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.