Hiploc System
5 catalogue numbers from 236055, listed by Biomet UK Ltd., United Kingdom, under Device, Fixation, Proximal Femoral, Implant. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
5catalogue numbers in this listing
4recalls on this code
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 UK Ltd., United Kingdom |
|---|---|
| FDA product code | JDO |
| Device type | Device, Fixation, Proximal Femoral, Implant |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K080685 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 236055 | Ø12.5 X 55MM | In distribution |
| 190101 | 16MM | In distribution |
| 236055 | Ø12.5 X 55MM | In distribution |
| 190102 | 16MM | In distribution |
| 190104 | 16MM | 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
4 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 UK Ltd. | 510(k) number | 2018-08-09 | Class II | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel | 1 unit | 2020-05-12 |
| Biomet UK Ltd. | 510(k) number | 2018-08-09 | Class II | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel | 10 units | 2020-05-12 |
| Biomet UK Ltd. | 510(k) number | 2018-08-09 | Class II | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel | 44 units | 2020-05-12 |
| Biomet UK Ltd. | 510(k) number | 2018-08-09 | Class II | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel | 6 units | 2020-05-12 |
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.