Polarstem
The POLARSTEM Cemented Femoral Stem is a stainless-steel hip implant intended for partial or total replacement of the hip joint. The filing describes it as replacing damaged hip-joint…
The POLARSTEM Cemented Femoral Stem is a stainless-steel hip implant intended for partial or total replacement of the hip joint. The filing describes it as replacing damaged hip-joint articulation in people with advanced degeneration or other specified hip conditions.
The subject filing distinguishes the cemented stem from other POLARSTEM femoral stem models. It lists indications including degenerative, post-traumatic or rheumatoid arthritis, femoral-head fracture or avascular necrosis, and failure of prior hip surgery. The submission includes mechanical performance testing for the cemented stem.
Listed Item
POLARSTEM COLLAR STANDARD NON-CEMENTED WITH Ti/HA 0
Cemented Stem Model
The FDA summary identifies a stainless-steel cemented stem for partial or total hip replacement. Mechanical testing is reported for this model-specific device.
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K203175 |
| Record published | 2015-10-20 |
| Record revised | 2025-07-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75100483 | In distribution | |
| 75002113 | In distribution | |
| 75002119 | In distribution | |
| 75002124 | In distribution | |
| 75002120 | In distribution | |
| 75102250 | In distribution | |
| 75103200 | In distribution | |
| 75102077 | In distribution | |
| 75002117 | In distribution | |
| 75100474 | In distribution | |
| 75002123 | In distribution | |
| 75002125 | In distribution | |
| 75102073 | In distribution | |
| 75018400 | In distribution | |
| 75103199 | In distribution | |
| 75002126 | In distribution | |
| 75102257 | In distribution | |
| 75100482 | In distribution | |
| 75100466 | In distribution | |
| 75100465 | In distribution | |
| 75102253 | In distribution | |
| 75000675 | In distribution | |
| 75002127 | In distribution | |
| 75002122 | In distribution | |
| 75102261 | In distribution | |
| 75002116 | In distribution | |
| 75102245 | In distribution | |
| 75018403 | In distribution | |
| 75100475 | In distribution | |
| 75023745 | In distribution | |
| 75002111 | In distribution | |
| 75018417 | In distribution | |
| 75102258 | In distribution | |
| 75100473 | In distribution | |
| 75023369 | In distribution | |
| 75018416 | In distribution | |
| 75100472 | In distribution | |
| 75102243 | In distribution | |
| 75002112 | In distribution | |
| 75002114 | In distribution | |
| 75018401 | In distribution | |
| 75102260 | In distribution | |
| 75100467 | In distribution | |
| 75002118 | In distribution | |
| 75002115 | In distribution | |
| 75002121 | In distribution | |
| 75100471 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250571 | 2025-03-28 |
| K240381 | 2024-06-27 |
| K203175 | 2021-07-22 |
| K211548 | 2021-07-19 |
| K151902 | 2015-09-03 |
| K143739 | 2015-04-20 |
| K143096 | 2015-03-24 |
| K132435 | 2013-10-22 |
| K130728 | 2013-10-10 |
| K122296 | 2012-08-28 |
| K120211 | 2012-07-19 |
| K110101 | 2011-04-11 |
| K100412 | 2010-05-05 |
| K093991 | 2010-04-15 |
| K083762 | 2009-03-11 |
| K082371 | 2009-02-09 |
| K072852 | 2008-06-09 |
| K061066 | 2006-07-14 |
| K053246 | 2006-07-12 |
| K052275 | 2005-12-07 |
| K021673 | 2002-06-11 |
| K013989 | 2001-12-19 |
| K991162 | 2000-01-28 |
| K981847 | 1998-07-17 |
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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-04-24 | Class II | Process control | Packaging contained the incorrect size of femoral head from what was displayed on the label. | 23 packages |
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.