Polarstem
POLARSTEM COLLAR STANDARD NON-CEMENTED WITH Ti/HA 11
9manufacturers in China registered for this device type
23catalogue numbers in this listing
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 | Smith & Nephew, Inc., United States |
|---|---|
| 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K143739 |
| Record published | 2016-07-25 |
| Record revised | 2025-11-28 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75018413 | In distribution | |
| 75102244 | In distribution | |
| 75018412 | In distribution | |
| 75100481 | In distribution | |
| 75100469 | In distribution | |
| 75100476 | In distribution | |
| 75100464 | In distribution | |
| 75102076 | In distribution | |
| 75100468 | In distribution | |
| 75102255 | In distribution | |
| 75102256 | In distribution | |
| 75100463 | In distribution | |
| 75100478 | In distribution | |
| 75100510 | In distribution | |
| 75018402 | In distribution | |
| 75102249 | In distribution | |
| 75102246 | In distribution | |
| 75100470 | In distribution | |
| 75018411 | In distribution | |
| 75102242 | In distribution | |
| 75102247 | In distribution | |
| 75102078 | In distribution | |
| 75018404 | 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 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| 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 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2024-10-15 | Class II | Under Investigation by firm | The Bipolar assembly contains an oversized Retainer Ring. | 21 devices | |
| Smith & Nephew Orthopaedics AG | 510(k) number | 2020-07-22 | Class II | Device Design | Multiple lots being recalled due to a product design issue | 528 unit | 2026-08-21 |
| Smith & Nephew, Inc. | 510(k) number | 2017-07-24 | Class II | Device Design | The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. | 402 units | 2020-08-21 |
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.