U2 Hip Stem
Revision hip stem trial, curved, right, Ø16.5×230mm
9manufacturers in China registered for this device type
60catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K062978 |
| Record published | 2018-06-21 |
| Record revised | 2022-09-16 (version 6) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1104-2416 | curved, right,φ16.5×230mm | In distribution |
| 9104-5301 | φ11, φ12mm | In distribution |
| 1104-2411-RB | curved, right, Ø11×230mm | In distribution |
| 1104-2416-RB | curved, right, Ø16.5×230mm | In distribution |
| 1104-2211 | straight, φ11×180mm | In distribution |
| 1104-2418-RB | curved, right, Ø18×230mm | In distribution |
| 1104-2311 | curved, left,φ11×230mm | In distribution |
| 1104-2312-RB | curved, left, Ø12×230mm | In distribution |
| 9104-8040-RA | In distribution | |
| 1104-2414 | curved, right, φ14×230mm | In distribution |
| 1104-2413 | curved, right, φ13×230mm | In distribution |
| 9104-5303-RB | Ø16.5, Ø18mm | In distribution |
| 1104-2215 | straight, φ15×180mm | In distribution |
| 1104-2216 | straight, φ16.5×180mm | In distribution |
| 1104-2412 | curved, right, φ12×230mm | In distribution |
| 9104-6380 | Ø16.5mm | In distribution |
| 1104-2411 | curved, right, φ11×230mm | In distribution |
| 9104-6370 | Ø15mm | In distribution |
| 9104-6390 | Ø18mm | In distribution |
| 9104-5303 | φ16.5, φ18mm | In distribution |
| 1104-2316 | curved, left,φ16.5×230mm | In distribution |
| 1104-2211-RB | straight, Ø11×180mm | In distribution |
| 9104-8050-RT | In distribution | |
| 1104-2418 | curved, right,φ18×230mm | In distribution |
| 1104-2312 | curved, left,φ12×230mm | In distribution |
| 1104-2415 | curved, right,φ15×230mm | In distribution |
| 9104-6340 | Ø12mm | In distribution |
| 1104-2413-RB | curved, right, Ø13×230mm | In distribution |
| 1104-2214 | straight, φ14×180mm | In distribution |
| 1104-2415-RB | curved, right, Ø15×230mm | In distribution |
| 9104-8040-RT | In distribution | |
| 9104-8050-RA | In distribution | |
| 1104-2214-RB | straight, Ø14×180mm | In distribution |
| 1104-2315 | curved, left,φ15×230mm | In distribution |
| 1104-2213 | straight, φ13×180mm | In distribution |
| 1104-2215-RB | straight, Ø15×180mm | In distribution |
| 9104-6330 | Ø11mm | In distribution |
| 1104-2318 | curved, left,φ18×230mm | In distribution |
| 9104-5302-RB | Ø13, Ø14, Ø15mm | In distribution |
| 9104-5302 | φ13, φ14, φ15mm | In distribution |
| 1104-2314-RB | curved, left, Ø14×230mm | In distribution |
| 1104-2213-RB | straight, Ø13×180mm | In distribution |
| 9104-6360 | Ø14mm | In distribution |
| 1104-2412-RB | curved, right, Ø12×230mm | In distribution |
| 1104-2313 | curved, left,φ13×230mm | In distribution |
| 1104-2311-RB | curved, left, Ø11×230mm | In distribution |
| 1104-2314 | curved, left,φ14×230mm | In distribution |
| 1104-2313-RB | curved, left, Ø13×230mm | In distribution |
| 1104-2316-RB | curved, left, Ø16.5×230mm | In distribution |
| 1104-2212 | straight, φ12×180mm | In distribution |
| 1104-2318-RB | curved, left, Ø18×230mm | In distribution |
| 1104-2212-RB | straight, Ø12×180mm | In distribution |
| 1104-2218 | straight, φ18×180mm | In distribution |
| 1104-2216-RB | straight, Ø16.5×180mm | In distribution |
| 1104-2218-RB | straight, Ø18×180mm | In distribution |
| 1104-2414-RB | curved, right, Ø14×230mm | In distribution |
| 9104-5301-RB | Ø11, Ø12mm | In distribution |
| 9104-8060 | In distribution | |
| 1104-2315-RB | curved, left, Ø15×230mm | In distribution |
| 9104-6350 | Ø13mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062978 | 2007-01-16 |
| K050262 | 2005-08-15 |
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.