TSP HIP FX Plating Systemimpaction PAD, Guide
Catalogue number 14-451551, listed by Biomet Orthopedics, United States, under Device, Fixation, Proximal Femoral, Implant. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDO |
| Device type | Device, Fixation, Proximal Femoral, Implant |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K140018 |
| Record published | 2016-09-26 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-451551 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BMP Compression HIP Screw | Biomet Orthopedics | 112 |
| DHS | Synthes Gmbh | 93 |
| THP™ Hip Fracture Plating System | Biomet Orthopedics | 74 |
| Percutaneous Compression Plate (Pc.c.p) | Orthofix SRL | 69 |
| Proform Hip System | Globus Medical, Inc. | 51 |
| Conquest FN | Smith & Nephew, Inc. | 31 |
| CHS | Smith & Nephew, Inc. | 26 |
| Large Cannulated Screws | Smith & Nephew, Inc. | 22 |
| TSP HIP FX Plating SYSTEM4.5MM Cortical NON – Locking Screw | Biomet Orthopedics | 13 |
| TSP HIP FX Plating SYSTEM4.5MM Cortical Locking Screw | Biomet Orthopedics | 12 |
| TSP HIP FX Plating SYSTEM7.5MM Telescoping LAG Screw | Biomet Orthopedics | 6 |
| Dhhs | Synthes Gmbh | 6 |
Showing 12 of 112. All products under Device, Fixation, Proximal Femoral, Implant
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-01-07 | Class II | Under Investigation by firm | Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging. | 1662 | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2016-06-10 | Class II | Device Design | The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw | 5458 units | 2017-07-20 |
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.