BI-Metric Interlok HIP System
6 catalogue numbers from 12-162301, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDG |
| Device type | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| 510(k) | K931194 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 4) |
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 |
|---|---|---|
| 12-162301 | 7 SIZE 115 MM TYPE1 TAPER | In distribution |
| 12-162308 | 14 SIZE 150 MM TYPE1 TAPER | In distribution |
| 12-162302 | 8 SIZE 120 MM TYPE1 TAPER | In distribution |
| 12-162306 | 12 SIZE 140 MM TYPE1 TAPER | In distribution |
| 12-162310 | 16 SIZE 160 MM TYPE1 TAPER | In distribution |
| 12-162304 | 10 SIZE 130 MM TYPE1 TAPER | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 554 |
| Emperion | Smith & Nephew, Inc. | 262 |
| Reflection | Smith & Nephew, Inc. | 253 |
| Spii Model Lubinus | Waldemar Link GmbH & Co. KG | 174 |
| Polar | Smith & Nephew, Inc. | 132 |
| Anthology | Smith & Nephew, Inc. | 129 |
| Echelon | Smith & Nephew, Inc. | 122 |
| Synergy | Smith & Nephew, Inc. | 102 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | Smith & Nephew, Inc. | 93 |
| Trigen | Smith & Nephew, Inc. | 66 |
| Prosthesis Head B | Waldemar Link GmbH & Co. KG | 62 |
| Corin Taper-Fit Total Hip System | Corin Limited | 55 |
Showing 12 of 71. All products under Prosthesis, Hip, Femoral Component, Cemented, Metal
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.